Document:

Exhibit
10.58

 

	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

	

 

February
18, 2022

 

Personal
and Confidential

 

Douglas
Plassche

***

***

 

Dear
Doug,

 

This
letter agreement (the “Agreement”) shall confirm our understanding as to the terms of your continuing employment with Elite
Laboratories, Inc., a Delaware corporation (the “Company”).

 

In
recognition of the value Elite places on your past and continued service to the Company, we are pleased to offer you an incentive to
continue to remain employed with the Company and to provide for the continuity of management and the success of the Company’s operations
during a period of substantial change by ensuring your commitment to continue to serve diligently in your present position through June
30, 2023. In consideration of the foregoing, provided that you remain continuously employed with the Company through June 30, 2023,
you will be entitled to a retention bonus of $300,000 less applicable withholding taxes, regardless of whether you remain with the Company
or leave the Company any time after June 30, 2023. The retention bonus shall be paid in two installments. The first installment shall
be paid on October 31, 2022, and the second on June 30, 2023. Further, in the period up to June 30, 2023 your salary will be adjusted
to $300,000 per year effective March 1st, 2021. These benefits will replace what is stated in your offer letter.

 

(Signature
Page follows)

 

165
Ludlow Avenue ● Northvale, NJ 07647 ● Ph: (201)750-2646 ● Fax: (201)750-2755 www.elitepharma.com

    	 

    	 

    

 

If
you find the foregoing arrangement acceptable and believe that the foregoing accurately summarizes our understanding, please kindly so
indicate by executing and dating the attached copy of this Agreement in the space provided and returning a copy to me.

 

Very truly yours,

 

	 	Elite
    Laboratories, Inc.
	 	 	 
	 	By:	/s/
    Nasrat Hakim
	 	 	Nasrat
    Hakim 
	 	 	President
    and CEO

 

	ACCEPTED
    & AGREED 	 
	 	 	 
	By:
    	/s/
    Douglas Plassche	 
	 	Douglas
    PlasscheExhibit
10.59

 

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

 

 

 

License,
SUPPLY

and
Distribution Agreement

 

FOR
VIGABATRIN

 

Elite
pharmaceuticals, inc.,

 

elite
laboratories, inc.,

 

-
and -

 

LANNETT
COMPANY, Inc.

 

Dated
as of July 20, 2021

 

 

 

    	 

     

    

 

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NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED 

 

THIS
LICENSE, SUPPLY AND DISTRIBUTION AGREEMENT is made as of July 20, 2021 (the “Effective
Date”), by and between ELITE PHARMACEUTICALS, INC. a Nevada corporation and ELITE LABORATORIES, INC., a Delaware corporation located
at 165 Ludlow Avenue, Northvale, New Jersey 07647 (collectively, “ELITE”),
and LANNETT COMPANY, INC., USA, a Delaware corporation located at 9000 State Road, Philadelphia, PA 19136 and/or its Affiliates (“LANNETT”).

 

WHEREAS:

 

	A.	ELITE
    has ownership rights to Products and/or ANDAs specified in Schedule A (the “Products”), and LANNETT wishes to license
    from ELITE the exclusive rights to market and sell the Products on the terms and conditions set forth in this Agreement.
	 	 
	B.	ELITE
    has significant experience in developing, manufacturing and marketing finished dosage forms of pharmaceutical products, including
    the Products;
	 	 
	C.	LANNETT
    has significant experience in marketing pharmaceutical products; and
	 	 
	D.	Subject
    to the terms and conditions of this Agreement, LANNETT desires to engage ELITE on an exclusive basis to manufacture, supply, package
    and label the Products and ELITE agrees to grant LANNETT the right under this Agreement to commercialize the Products in the Territory
    on an exclusive basis.

 

NOW,
THEREFORE in consideration of the mutual covenants and obligations contained herein and other good and valuable consideration, the
receipt and sufficiency of which is hereby acknowledged, the Parties hereto agree as follows:

 

ARTICLE
1 - DEFINITIONS

 

	1.1	In
    addition to terms defined elsewhere in this Agreement, the terms set forth below shall be defined in this Agreement (including the
    recitals) as follows:
	 	 	 
	 	 	(a)	“Affiliate”
    with respect to either Party means any Person who directly or indirectly through one or more intermediaries controls, is controlled
    by, or is under common control with such Party. The term “control” means the beneficial (direct or indirect) ownership
    of more than fifty percent (50%) of the voting or equity interests of such Person or the power or right to direct the management
    and affairs of its business, whether through the ownership of voting securities, by contract, or otherwise.
	 	 	 	 
	 	 	(b)	“Agreement”
    means this License, Supply and Distribution Agreement, together with all schedules hereto.
	 	 	 	 
	 	 	(c)	Analytical
    Specifications” has the meaning given in Article 4.1(a).
	 	 	 	 
	 	 	(d)	“ANDA”
    means an Abbreviated New Drug Application pursuant to Section 505(j) of the FDCA.
	 	 	 	 
	 	 	(e)	“Bankruptcy
    Code” has the meaning given in Article 14.16.

 

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NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED 

 

	 	 	(f)	“Business
    Day” in relation to each Party means any day other than a Saturday, a Sunday, or any statutory or public holiday on which
    banks are generally closed for regular business in New York, New York.
	 	 	 	 
	 	 	(g)	“Certificate
    of Analysis” means a certificate of analysis that certifies that a given batch of Product meets the release Product Specifications.
	 	 	 	 
	 	 	(h)	“Claim”
    means any claim, action, cause of action, or demand.
	 	 	 	 
	 	 	(i)	“Commercially
    Reasonable Efforts” with respect to any activity means the efforts and resources that would be used in the performance
    of the relevant activity in compliance with Law by a Person (engaged in the manufacture and supply or distribution, sale and commercialization
    of pharmaceutical products, as applicable) of comparable size and resources as the applicable Party with regard to a product at a
    similar stage in its product life taking into account the following factors to the extent reasonable and relevant: issues of safety
    and efficacy, product profile, market potential, competitive market conditions, duration of exclusivity or other proprietary position
    of the product and the potential profitability and economic return of the product, all as measured by the facts and circumstances
    at the time such efforts are due. 
	 	 	 	 
	 	 	(j)	“Confidential
    Information” has the meaning given in Article 12.2.
	 	 	 	 
	 	 	(k)	“DEA”
    shall mean the United States Drug Enforcement Administration or any successor entity.
	 	 	 	 
	 	 	(l)	“Debarred
    Entity” has the meaning given in Article 9.2(c).
	 	 	 	 
	 	 	 	 
	 	 	(m)	“Debarred
    Individual” has the meaning given in Article 9.2(c).
	 	 	 	 
	 	 	(n)	“Distribution
    Fees” means three percent (3%) of Net Sales for all Products.
	 	 	 	 
	 	 	(o)	“Effective
    Date” has the meaning given in the preamble.
	 	 	 	 
	 	 	(p)	“Facility”
    means the ELITE FDA-approved manufacturing site located at 135/165 Ludlow Avenue,
    Northvale, NJ, USA 07647.
	 	 	 	 
	 	 	(q)	“FDA”
    means the United States Food and Drug Administration or any successor government agency.
	 	 	 	 
	 	 	(r)	“FDCA”
    means the Federal Food, Drug, and Cosmetic Act.
	 	 	 	 
	 	 	(s)	“Force
    Majeure Event” has the meaning given in Article 14.5.
	 	 	 	 
	 	 	(t)	“ELITE”
    has the meaning given in the preamble.
	 	 	 	 
	 	 	(u)	“GMP”
    means current good manufacturing practices for the manufacture of finished pharmaceutical products in effect within the Territory
    from time to time during the Term of this Agreement, which set minimum standards to ensure that pharmaceutical products meet established
    requirements for identity, strength, quality and purity, as established under the Laws of the Territory, including 21 C.F.R. Parts
    210 and 211.

 

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 (I)
NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED 

 

	 	 	(v)	 “Gross
    Sales” means the gross amount invoiced by LANNETT or its Affiliates or sublicensees for sales of the Product to Third Parties
    in the Territory.
	 	 	 	 
	 	 	(w)	“Indemnitee”
    has the meaning given in Article 11.3.
	 	 	 	 
	 	 	(x)	“Indemnitor”
    has the meaning given in Article 11.3.
	 	 	 	 
	 	 	(y)	“Intellectual
    Property Rights” means any patent, trademark, copyright, trade secret, right in unpatented know-how, right of confidence
    and any other intellectual or industrial property right of any nature whatsoever in any part of the world, whether registered or
    unregistered.
	 	 	 	 
	 	 	(z)	“LANNETT”
    has the meaning given in the preamble. 
	 	 	 	 
	 	 	(aa)	 “Law”
    means any federal, state, provincial and local laws, statutes, regulations, rules, guidelines, orders, ordinances, and any other
    requirements of any government or Regulatory Authority in the Territory applicable to the development, registration, manufacturing,
    testing, packaging, storing, shipping, marketing, distribution and sale of pharmaceutical products or as otherwise applicable to
    the Parties respective obligations under this Agreement, including the FDCA.
	 	 	 	 
	 	 	(bb)	“Losses”
    means any damages, liabilities, obligations, costs, expenses or losses, including reasonable legal fees and expenses, court costs,
    penalties, fines, costs of investigation and amounts paid in settlement of claims.
	 	 	 	 
	 	 	(cc)	“Major
    Change” shall mean a change that has the potential to adversely impact quality, identity, purity or stability of the Products
    or the compliance and validity of the Products Marketing Authorizations, as these factors may relate the safety or efficacy of the
    Product and as defined in the FDA regulations and guidance. 
	 	 	 	 
	 	 	(dd)	 “Marketing
    Authorization” means all approvals, licenses, registrations or authorizations of any Regulatory Authority, necessary for
    the manufacturing, use, storage, import, transport, marketing, promotion and sale of the Product in the Territory, together with
    pricing or reimbursement approval in countries where governmental approval is required for pricing or for the Product to be reimbursed
    by national health insurance.
	 	 	 	 
	 	 	(ee)	“Net
    Sales” shall mean with respect to the Product, Gross Sales less the following items (whether or not separately stated on
    such invoice but only to the extent included in Gross Sales):

 

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NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED 

 

	 	(i)	Any
    and all promotional allowances, rebates, charge backs, quantity and cash discounts, and other usual and customary discounts to customers;
	 	 	 
	 	(ii)	Amounts
    refunded, repaid or credited by reason of rejections, returns or recalls of goods;
	 	 	 
	 	(iii)	Any
    sales, excise, turnover, inventory, value-added, and similar taxes and duties assessed on applicable sales;
	 	 	 
	 	(iv)	Failure
    to Supply penalties (in the case if Article 4.4 (i) and (ii)), Non-affiliate third party administrative fees granted, Medicaid and
    state and/or governmental rebates, and shelf stock adjustments and retroactive price reductions.
	 	 	 
	 	Components
    of Net Sales shall be determined using the accrual method of accounting in accordance with US GAAP or an equivalent stipulated method
    of accounting in the Territory.

 

	 	 	(ff)	“Net
    Profits” is calculated as listed in Schedule C and means the Net Sales of a Product, minus the sum of (i) the Distribution
    Fee, (ii) Transfer Price of Product and (iii) shipping costs from the Facility.
	 	 	 	 
	 	 	(gg)	 “Non-Conforming
    Product” has the meaning given in Article 4.8(b). 
	 	 	 	 
	 	 	(hh)	“Original
    Agreement” has the meaning given in Recital A.
	 	 	 	 
	 	 	(ii)	“Packaging”
    means all material used to prepare fully packaged Products, including labeling, containers, closures, cartons, and shipping cases,
    as applicable.
	 	 	 	 
	 	 	(jj)	“Parties”
    means the parties to this Agreement referred to collectively, and “Party” means either party to this Agreement
    referred to individually.
	 	 	 	 
	 	 	(kk)	“Person”
    includes any individual, partnership, corporation, unincorporated organization or association, joint venture, limited liability company,
    trust or any other form of entity.
	 	 	 	 
	 	 	(ll)	“Safety
    Data Exchange Agreement or SDEA” means the pharmacovigilance agreement to be entered into by the Parties which shall set
    forth the safety data exchange procedures to be followed by the Parties for the collection, investigation, reporting and exchange
    of information concerning adverse events. 
	 	 	 	 
	 	 	(mm)	“Products”
    means the finished pharmaceutical products in commercially saleable form, as manufactured by ELITE exclusively supplied to LANNETT
    pursuant to this Agreement as set forth on Schedule A. 
	 	 	 	 
	 	 	(nn)	“Purchase
    Order” means a written, binding purchase order for a certain quantity of Product properly issued by LANNETT in accordance
    with the terms of this Agreement.
	 	 	 	 
	 	 	(oo)	“Quality
    Agreement” means a quality agreement to be entered into by the Parties which will set forth certain obligations of the
    Parties in relation to the manufacture, packaging, quality control and testing of the Products in accordance with GMP.

 

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NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED 

 

	 	 	(pp)	“Recall”
    shall mean a recall, removal, market withdrawal, seizure, or field correction of Product.
	 	 	 	 
	 	 	(qq)	“Regulatory
    Authorities” means any federal, state, local or international regulatory agency, department, bureau or other governmental
    entity responsible for regulating the manufacture, use, storage, importation, transportation, distribution marketing, promotion and
    sale of pharmaceutical products in the Territory, including the FDA and DEA.
	 	 	 	 
	 	 	(rr)	“Regulatory
    Approval” means all approvals or authorizations granted by the FDA for marketing the Products in the Territory.
	 	 	 	 
	 	 	(ss)	“Specifications”
    means the written methods, formulae, procedures, specifications, tests (and testing protocols) and standards pertaining to the
    Products as approved by FDA in the Product’s ANDA and attached herein as Schedule B, which may be amended from time-to-time
    by the written agreement of the Parties.
	 	 	 	 
	 	 	(tt)	 “Term”
    has the meaning given in Article 8.1.
	 	 	 	 
	 	 	(uu)	“Territory”
    means the United States of America and its possessions, territories, protectorates, military bases and commonwealths.
	 	 	 	 
	 	 	(vv)	“Third
    Party” means any Person other than LANNETT or ELITE, or any of their respective Affiliates.
	 	 	 	 
	 	 	(ww)	“Trademarks”
    has the meaning given in Article 4.3(a).
	 	 	 	 
	 	 	(xx)	“Transfer
    Price” is listed and defined in Schedule A.

 

	1.2	Interpretation
    of “Include”. Where the words “include”, “includes” or “including” are used in
    this Agreement, they shall mean, respectively, “include without limitation”, “includes without limitation”,
    “including but not limited to”, or “including without limitation”.

 

ARTICLE
2 - MARKETING AUTHORIZATIONS

 

	2.1	Subject
    to the terms of this Agreement, ELITE shall exclusively manufacture, supply, package and label the Products for LANNETT, and LANNETT
    shall have the right to promote, market, store, distribute and sell the Products in the Territory. ELITE hereby grants to LANNETT
    and its Affiliates an exclusive right to fully commercialize the Products in the Territory. LANNETT agrees to exclusively purchase
    Products it requires from ELITE.
	 	 
	2.2	ELITE
    shall, at their expense, maintain and update the Marketing Authorizations for the Products as may be required for the Parties to
    perform their obligations hereunder. ELITE shall be solely responsible for all communications with the Regulatory Authorities in
    the Territory relating to any Marketing Authorizations for the Products. ELITE shall provide LANNETT with timely notice of any communications
    from the Regulatory Authorities which may affect ELITE’s right or ability to supply LANNETT with the Products.

 

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ARTICLE
3 - PAYMENT TERMS

 

	3.1	Transfer
    Price. ELITE shall sell each Product to LANNETT at the prices set forth in Schedule A, which Transfer price shall be inclusive
    of all costs and expenses associated with the manufacture, supply, packaging, labeling of the Product to LANNETT. 
	 	 
	3.2	Upon
    delivery of the Products to LANNETT, ELITE shall submit invoices therefore to LANNETT. LANNETT shall pay each undisputed invoice
    in full within thirty (30) days of its receipt in full of the Products reflected in the invoice and the Certificate of Analysis,
    which Certificate is in a form sufficient for release of the Products. A late payment fee of one percent (1%) per month may be imposed
    upon LANNETT for payments past due, unless Products therein are subject to a quality dispute. In the event of any inconsistency between
    an invoice and this Agreement, the terms of this Agreement shall control.
	 	 
	3.3	License
    Fees. Within forty-five (45) days of the end of each calendar quarter, LANNETT shall pay to ELITE a License Fee of *** percent (**%)
    of the Net Profits received from sales of each Product. Such payment shall additionally include a sales summary for each Product
    generally in the format as provided in Schedule C. In no case shall the License Fee for any calendar quarter be negative;
    provided, however in the event of a loss in any calendar quarter, subject to ELITE’s written approval of any Product pricing
    by LANNETT that leads to quarterly losses and subject to the loss carryover clause that follows, the amount of that loss shall be
    carried forward to subsequent calendar quarters until the amount of such loss has been fully absorbed. If Net Profits for calendar
    quarter are negative, LANNETT shall carry over the applicable License Fee percentage set forth above multiplied by the value by which
    the Net Profits are negative in such calendar quarter and deduct this amount from the calculation of Net Sales for the following
    calendar quarter. If Net Profits are negative in two (2) or more consecutive calendar quarters, LANNETT shall invoice ELITE the applicable
    License Fee percentage set forth above multiplied by the value by which the Net Profits are negative for the previous calendar quarter
    and carry over the applicable License Fee percentage set forth above multiplied by the value by which Net Profits are negative for
    the current calendar quarter and deduct this amount from the calculation of Net Sales for the following calendar quarter. For the
    avoidance of doubt, if Net Profits are negative in subsequent calendar quarters, the amounts will be similarly carried over or reimbursed
    as per the terms set forth in this Section 3.3 until Net Profits are positive. Reimbursement of negative Net Profits owed by ELITE
    in this Section 3.3 shall be payable to LANNETT within forty-five (45) days after receipt of an invoice from LANNETT.

 

ARTICLE
4 - MANUFACTURING AND SUPPLY; COMMERCIALIZATION

 

	4.1	Supply of Products. 
	 	 	 
	 	 	(a)	During
    the Term of this Agreement, ELITE shall use Commercially Reasonable Efforts to manufacture, timely supply, package and label for
    delivery to LANNETT the Products in accordance with any Purchase Orders issued by LANNETT under the terms of this Agreement. Purchase
    Orders shall include the shipping instructions in accordance with Schedule D hereto ELITE shall manufacture, supply, package
    and label the Products in compliance with all Laws, including the GMPs, the Marketing Authorization, the Quality Agreement, and the
    Specifications (“Analytical Specifications”). 

 

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	 	 	(b)	ELITE
    shall manufacture the Products in the Facility and use Commercially Reasonable Efforts to maintain access to sufficient supplies
    of raw materials, components and other required resources to perform its obligations under this Agreement, and meet LANNETT’s
    supply requirements for the Products. ELITE shall not manufacture the Products at a site other than the Facility without first obtaining
    LANNETT’s prior written consent, which consent shall not be unreasonably withheld. ELITE shall be solely responsible for all
    costs and expenses incurred in connection with the manufacture of the Products hereunder, including without limitation costs and
    expenses of personnel, quality control, testing, manufacturing, facilities, equipment, materials, FDA product fees, FDA establishment
    fees and government sales, use, excise, property or similar taxes or excises.
	 	 	 	 
	 	 	(c)	ELITE
    shall have procedures in place to ensure that the oldest approved inventory of the Products is distributed first. In addition, each
    Party shall maintain a tracking system by which the distribution of each lot of the Products may be readily determined to facilitate
    its Recall if necessary.
	 	 	 	 
	 	 	(d)	Transfer
    Price Adjustments. The Transfer Prices for the Products under Schedule A are valid through December 31, 2022. After December
    31, 2022, the Transfer Price for Products may be adjusted for any increase in the cost of active pharmaceutical ingredients, annual
    Generic Drug User Fees (GDUFA fees) proportional allocation, and other material government mandated requirements. ELITE shall provide
    at least thirty (30) days written notice to LANNETT for any such Transfer Price adjustments with justifications for any increase.
    ELITE shall use commercially reasonable efforts to reduce its manufacturing expenses for the Products. At either Party’s written
    request, the Parties will discuss in good faith the revision of the Transfer Price (and any subsequently agreed prices) to take into
    account adverse market conditions resulting in unsatisfactory returns for LANNETT or changes in the manufacturing costs for the Products.
    The revised Transfer Price shall be laid down in writing and inserted as an amended Schedule A to this Agreement. Confirmed
    orders are excluded from Transfer Price negotiations. If, after good faith negotiations, the Parties are unable to reach agreement
    on an adjustment to the Transfer Pricing for the Products, then LANNETT shall be entitled to terminate this Agreement, effective
    upon at least sixty (60) days’ prior written notice to ELITE.
	 	 	 	 
	 	 	(e)	The
    Parties shall enter into a Safety Data Exchange Agreement and Quality Agreement. The respective roles and responsibilities for quality
    assurance personnel of the Parties in carrying out the transactions pursuant to this Agreement shall be defined and stipulated in
    the Quality Agreement. The fully executed SDEA (SDEA) and Quality Agreement are hereby incorporated and made a part of this Agreement
    by reference. In the event of any inconsistency between the provisions of the SDEA and the provisions of this Agreement, the wording
    of the SDEA shall govern any and all patient safety matters and this Agreement shall govern all other matters. The Parties hereby
    acknowledge and agree that in the event of any conflict between the terms of this Agreement and the terms of the Quality Agreement,
    this Agreement shall control with respect to all issues (other than with respect to all quality matters), and the Quality Agreement
    shall control with respect to all quality matters.

 

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	4.2	Master
    Production Plan and Purchase Orders. On or before fifteen (15) days prior to the end of each calendar quarter during the Term,
    LANNETT shall deliver to ELITE a master production plan which covers a twelve (12) month period, which includes three (3) months
    binding purchase order, and nine (9) months non-binding forecast (the “Master Production Plan”). The first three
    months (beginning with the first month following the month in which the Master Production Plan is due) of each Master Production
    Plan shall be deemed to be a binding purchase order (the “Binding Forecast”). Months four (4) through twelve (12)
    of the Master Production Plan shall be LANNETT’s non-binding, good faith estimate of such requirements based on forecasted
    trade and LANNETT shall have the ability to adjust the quantities forecast. Unless the Parties otherwise agree in writing, all firm
    orders for Product (the “Purchase Order”) placed shall specify: (i) the type of Product being ordered; (ii) the
    amount of such Product being requested (which shall be in whole batch size quantities); and (iii) the requested delivery date
    which, unless otherwise agreed by ELITE in writing, shall be not less than ninety (90) days after receipt of the Purchase Order.
    Each Master Production Plan and accompanying binding Purchase Order shall be deemed to be automatically accepted unless ELITE notifies
    LANNETT of its rejection of the same within four (4) Business Days of receipt. ELITE may only reject a Purchase Order if a Purchase
    Order is not consistent with the terms of this Article 4.2 or is not timely delivered. Once a Purchase Order is accepted by
    ELITE, ELITE shall be obligated to timely manufacture, supply, package, label, and have ready for delivery the full quantities of
    Products set forth in the Purchase Order by the required delivery date at the Facility. In the event that the terms of any Purchase
    Order are not consistent with, or attempt to modify, the terms of this Agreement, the terms of this Agreement shall prevail. If LANNETT
    requests changes to any Purchase Order after receipt thereof by ELITE, ELITE shall use Commercially Reasonable Efforts to comply
    with such changes. ELITE shall use Commercially Reasonable Efforts to supply up to one hundred twenty-five percent (125%) of LANNETT’S
    requirement forecast of Products for the applicable period.

 

	4.3	Delivery Terms.
	 	 	 
	 	 	(a)	LANNETT
    shall provide ELITE packaging specifications and related materials that comply with FDA requirements and the Parties will finalize
    all packaging by the time of the first Purchase Order. If requested by LANNETT, ELITE shall affix on the Product and/or on the label
    and/or the packages certain proprietary or registered marks, logos or insignia relating to the Product in accordance with the directions
    and specifications given by LANNETT, along with any other marks, logos or insignia, as LANNETT may stipulate from time to time (collectively,
    “Trademark”). Pursuant to the aforesaid, LANNETT hereby grants to ELITE, a non-exclusive, non-transferable, non-assignable
    and non-sublicensable right to the Trademarks, solely for the purpose of affixing such Trademarks to the Product in accordance with
    LANNETT’s directions and specifications during the Term. LANNETT shall have sole approval authority over all Product labeling
    and packaging specifications of the Products supplied to LANNETT pursuant to this Agreement.

 

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NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED 

 

	 	 	(b)	ELITE
    shall deliver the full quantities of the Products set forth in each Purchase Order (Incoterms 2010 EXW) to LANNETT or its designee.
    All Products shall be packaged for shipment in accordance with the packaging specifications set forth in the Marketing Authorizations
    and packing instructions reasonably required by LANNETT. 
	 	 	 	 
	 	 	(c)	Each
    Products shipment made by ELITE shall be accompanied by and shall include a Certificate of Analysis for each shipment of the Products
    manufactured and supplied hereunder. ELITE shall be responsible for all applicable release testing of the Products in accordance
    with the Analytical Specifications. ELITE shall perform all required in-process quality control tests and quality assurance reviews
    on the Products, including without limitation, stability testing at its sole cost and expense. In addition, ELITE shall furnish LANNETT,
    along with the first shipment of the Products, ELITE’s Material Safety Data Sheets containing the relevant safety and health
    information and such other similar information as LANNETT may reasonably from time-to-time request in connection therewith.
	 	 	 	 
	 	 	(d)	All
    Products provided to LANNETT shall have no less than eighty five percent (85%) remaining shelf-life remaining as per the Product’s
    ANDA.
	 	 	 	 
	 	 	(e)	All
    orders containing at least ninety percent (90%) of the specified amount of Product in a Purchase Order shall be deemed satisfied.

 

	4.4	Failure
    to Supply. ELITE shall notify LANNETT as promptly as possible, but in no event later than five (5) Business Days, after ELITE
    discovers that it will not be able to supply the quantity of Products ordered by the delivery date specified in a Purchase Order.
    In such event: (i) ELITE shall cooperate with LANNETT in taking all actions that LANNETT deems reasonably necessary in order to remedy
    such inability to supply, at ELITE’s expense; and (ii) If ELITE’s inability to supply continues past twenty (20) days
    from the required delivery date set forth in the Purchase Order at LANNETT’s election, any or all outstanding Purchase Orders
    relating to such Product may be cancelled and LANNETT shall have no obligations with respect to such Purchase Orders; provided, however,
    ELITE must cover any Failure to Supply (as defined below) obligations set forth in this Section. Compliance by ELITE with this Article
    4.4 shall not relieve ELITE of any other obligation or liability under this Agreement. LANNETT shall otherwise retain all of
    its rights under this Agreement and/or at law against ELITE for its failure to deliver all or any portion of the quantity of Products
    ordered by LANNETT. With regards to a Binding Forecast or if ELITE accepted a Purchase Order from LANNETT, pursuant to the procedures
    defined in Section 4.2 of this Agreement, then ELITE shall be responsible for the late charges and any penalties assessed against
    LANNETT by its Customers or any other third party or any costs, fees, charges, or penalties incurred by Lannett (“Failure to
    Supply”), unless the delay is attributable to (i) action or controls imposed by the DEA 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,
    but ELITE will use commercially reasonable efforts to keep three (3) to six (6) months of raw materials inventory on hand at all
    times. Late charges and any penalties assessed against ELITE by LANNETT under this paragraph are due and payable within thirty (30)
    days of being invoiced by LANNETT and, if not timely paid, may be deducted against amounts owed by LANNETT to ELITE.

 

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	4.5	Samples
    and Batch Records. ELITE shall prepare and maintain batch records and file samples, properly stored, for each lot or batch of
    Products manufactured and shipped hereunder in compliance with all GMPs and Laws in the Territory.
	 	 
	4.6	Commercialization.
    LANNETT shall use Commercially Reasonable Efforts to market and sell the Products in the Territory. All commercial matters regarding
    the marketing, promotion, sale, offer for sale, pricing or distribution of the Products in the Territory shall be under the exclusive
    control of LANNETT. 
	 	 
	4.7	Change
    of Specification. No alterations of the Specifications for the Products or other changes requiring prior approval by the FDA,
    or material changes to the manufacturing process or validated processes, can be made without the prior written approval of LANNETT.
    ELITE shall notify LANNETT in writing of any proposed alterations for the Specifications for the Products or any Major Changes to
    the manufacturing process or validated processes. LANNETT shall notify ELITE of LANNETT’s decision within thirty (30) days
    of receipt of such proposal from ELITE. If ELITE does not receive LANNETT’s decision in writing within thirty (30) days, the
    alteration of the Specifications or other Major Changes to the manufacturing process or validated process proposed by ELITE shall
    be deemed rejected by LANNETT. In the event that the FDA or any other governmental authority shall suggest or mandate any change
    or revision to the Product, such that the Specifications would no longer comply with such suggestion or mandate, the Parties shall
    work together in good faith to develop revised Specifications that meet all changes or revisions suggested or mandated by the FDA
    or other governmental authority and Schedule B shall be amended in writing to set forth the new agreed upon Specifications.

 

	4.8	Acceptance
                    of the Product.

	 	 	 
	 	 	(a)	Following
    receipt of a shipment of Product at the final destination, LANNETT, or its designee, shall conduct a visual inspection of the Product
    and all accompanying documents provided by ELITE, including without limitation, the Certificate of Analysis, in accordance with its
    customary procedures. LANNETT shall advise ELITE, in writing, if it is rejecting a shipment of Product due to obvious physical damage
    or obvious packaging defect that are evident upon such visual inspection of the packaged Product as shipped by ELITE. LANNETT (and
    its designees) shall have no obligation to inspect the Product beyond the visual inspection provided for in this Article 4.8(a).
	 	 	 	 
	 	 	(b)	In
    the case of defects other than those obvious defects described in Article 4.8(a), including, by way of example, any failure
    of the Product, at the time of delivery, to meet the Analytical Specifications and the representations, warranties and covenants
    of Article 9.2(f), LANNETT shall promptly notify ELITE if it becomes aware of such non-obvious defect(s). Any defect in physical
    condition of Products delivered by ELITE or Products that do not conform with the Analytical Specifications (as may be in effect
    from time to time) or the representations, warranties and covenants of Article 9.2(f) for any reason shall be deemed to be
    a non-conforming product (“Non-Conforming Product”). LANNETT, or its designee, shall have the right to reject
    any Non-Conforming Product and no failure on the part of LANNETT, or its designee, or passage of time shall prejudice LANNETT’s
    right to reject or revoke acceptance of Non-Conforming Product. All Non-Conforming Product shall be returned to ELITE at its sole
    cost and expense.

 

 

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	 	 	(c)	If
    ELITE confirms the Non-Conforming Product or lab testing pursuant to Article 4.8(d) determines that the Product is Non-Conforming
    Product, ELITE shall, at LANNETT’s election, either replace such Non-Conforming Product with conforming Product or, refund
    to LANNETT, the price paid for such Non-Conforming Product.
	 	 	 	 
	 	 	(d)	If
    the Parties cannot agree as to whether a delivered quantity of Product is Non-Conforming Product, then the Parties agree to have
    the batch in dispute tested and further analyzed by a recognized independent testing laboratory selected by the Parties or a quality
    consultant (if not a laboratory analysis issue). The appointment of such laboratory or quality consultant shall not be unreasonably
    withheld or delayed by either Party. The decision of the laboratory or quality consultant shall be in writing and, save for manifest
    error on the face of the decision, shall be binding on both Parties. Should said laboratory’s testing or quality consultant
    determine that the Product is Non-Conforming Product then ELITE will bear the cost of such testing or quality consultant and comply
    with the terms of Article 4.8(c). If said Product is determined to have been conforming, then LANNETT shall bear all costs
    of the independent laboratory testing or quality consultant as well as accept the Product shipment and pay for same within forty-five
    (45) days of such acceptance.

 

ARTICLE
5 - INSPECTIONS

 

	5.1	Inspections.
    During the Term of this Agreement and thereafter in the event of a Claim against either Party regarding use of the Products is threatened
    or commenced, ELITE shall permit LANNETT’s representatives to enter ELITE’s facilities, upon reasonable prior notice
    (except in the event of a for-cause audit) and during normal business hours, for the purpose of inspecting the facility and quality
    control procedures and confirming compliance with all applicable GMPs and Laws in the Territory, the requirements of the Regulatory
    Authorities in the Territory, the Quality Agreement and this Agreement. If during any such inspection LANNETT discovers any instances
    in which ELITE has not complied with the foregoing, then ELITE shall promptly provide to LANNETT a written plan for correcting such
    deficiencies, including a proposed timetable for implementing such corrections, and shall ensure that such deficiencies are corrected,
    at ELITE’s sole expense, as soon as reasonably practicable. ELITE agrees to provide LANNETT with copies of all: (i) reasonably
    requested documentation in its possession relating to the manufacture of Product, Specifications, compliance with quality assurance
    standards, raw material vendors and manufacturing processes; and (ii) U.S. and international regulatory approvals, regulatory inspections
    of the manufacturing process, facilities and documentation, and other communications with Regulatory Authorities related to the Product;
    however ELITE shall not be required to provide copies to LANNETT of ELITE’s proprietary information and ELITE shall only be
    required to allow LANNETT to inspect such proprietary information such as batch records at ELITE’s site and under ELITE’s
    supervision. Notwithstanding the provision of this Article 5.1, LANNETT shall have no obligation or be deemed to have an obligation
    to inspect ELITE’s facilities.
	 	 
	5.2	Regulatory
    Authority Inspections. ELITE shall permit any Regulatory Authority to inspect the facility used to manufacture the Products
    and all associated records to the full extent permitted by applicable Law (“Regulatory Inspection”). ELITE shall
    notify LANNETT within forty-eight (48) hours of becoming aware of any planned or actual Regulatory Inspection. ELITE agrees to reasonably
    cooperate with the applicable Regulatory Authority in connection with such audits. ELITE shall notify LANNETT prior to the commencement
    of any meetings with, or inspection activity by, any Regulatory Authority, unless such inspection activity is an unannounced inspection.
    Further, ELITE shall provide a reasonable description to LANNETT of any such governmental inquiries, notifications or inspections
    related to Products promptly (but in no event later than five (5) calendar days) after such visit or inquiry. ELITE shall furnish
    to LANNETT: (i) within five (5) calendar days after receipt, any report or correspondence issued by the Regulatory Authority in connection
    with such visit or inquiry, including but not limited to, any FDA Form 483, establishment inspection report, or warning letter; and
    (ii) copies of any and all responses or explanations to any Regulatory Authority relating to items set forth above prior to the submission
    of such responses or explanations to any Regulatory Authority by ELITE for comment, which comments shall be taken into consideration
    by ELITE in good faith. ELITE shall also provide LANNETT with a copy of all final responses.

 

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ARTICLE
6 - RECORDS

 

	6.1	Records.
    ELITE and LANNETT shall maintain all records necessary to comply with all applicable Laws in the Territory relating to the performance
    of their respective obligations under this Agreement. ELITE shall also maintain, or cause to be maintained (i) all manufacturing
    records, standard operating procedures, validation records, equipment log books, batch records, laboratory notebooks and all raw
    data relating to the manufacturing of the Products, and (ii) such other records as LANNETT may reasonably require in order to ensure
    compliance by ELITE with the terms of this Agreement. All such records shall be maintained for such period as may be required pursuant
    to the applicable Laws.
	 	 
	6.2	Inspection
    of ELITE Books and Records. During the Term of this Agreement, and thereafter for the greater of (i) the period stipulated by
    the Laws in the Territory, and (ii) two (2) years from the expiration of the last Products manufactured, ELITE agrees that LANNETT,
    at reasonable times upon reasonable prior notice, may inspect the research and development books and records of ELITE pertaining
    to ELITE’s obligations under this Agreement for purposes of ensuring compliance with the terms of this Agreement.
	 	 
	6.3	Inspection
    of LANNETT Books and Records. LANNETT shall keep, and shall require its Affiliates to maintain, in connection with the handling,
    sale, and distribution of the Product hereunder, books and records necessary to allow the accurate calculation, consistent with GAAP,
    of the amounts due to ELITE, the reporting obligations contemplated herein, and compliance with the terms of this Agreement, and
    LANNETT shall maintain such books and records for a period of at least two (2) years after the end of the calendar year in which
    they were generated, or for such longer period as may be required by Applicable Law. Upon at least thirty (30) days prior written
    notice, ELITE, at its expense, shall have the right to have an independent public accounting or auditing firm, reasonably acceptable
    to LANNETT, obtain access to such books and records as may be reasonably necessary to determine or verify the amount of payments
    due under this Agreement and compliance with the obligations hereof; provided, however, that this right may not be exercised more
    than once in any calendar year. Such accounting firm shall conduct such examination, and LANNETT shall make such books and records
    available, during normal business hours at the facility(ies) where such books and records are customarily maintained. Each such examination
    shall be limited to pertinent books and records for any year ending not more than twenty-four (24) months prior to the date of request,
    except that ELITE shall not be permitted to audit the same period of time more than once. The independent accounting firm will prepare
    and provide to each Party a written report stating whether the reports submitted and amounts paid are correct or incorrect and the
    amounts of any discrepancies. The conclusions of such accounting firm shall be final and binding on the Parties absent demonstrable
    error. If there was an underpayment by LANNETT hereunder, LANNETT shall promptly (but in no event later than thirty (30) days after
    its receipt of the independent auditor’s report so concluding) make payment to ELITE of any shortfall by wire transfer in U.S.
    dollars, plus interest on the amount of such shortfall calculated at the lesser of (a) five percent (5%) per annum, or (b) the maximum
    rate permitted by law from the date such payment should have been made to the date the shortfall is paid. If there was an overpayment
    by LANNETT hereunder, ELITE shall promptly (but in no event later than thirty (30) days after ELITE’s receipt of the independent
    auditor’s report so concluding) refund to LANNETT the excess amount by wire transfer in U.S. dollars. All costs of the audit,
    including the expenses of the independent accounting firm, shall be borne by ELITE unless the underpayment by LANNETT results in
    a cumulative discrepancy during any calendar year in excess of the greater of (i) ten percent (10%) of the total amount reported
    to ELITE for that period or (ii) one hundred thousand dollars ($100,000.00), in which case all reasonable and documented costs of
    the audit, including the expenses of the independent accounting firm, shall be borne and promptly paid by LANNETT. ELITE shall ensure
    that the independent public accountant or auditor maintains the confidentiality of LANNETT’s Confidential Information on terms
    no less restrictive than those set forth in this Agreement.

 

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	6.4	Annual
    Reports. ELITE shall provide Lannett in a timely manner copies of ELITE’s
    annual reports to the FDA or any other Regulatory Authority with respect to the Products.

 

ARTICLE
7 - RECALLS

 

	7.1	Notification
    of Recall. If any Regulatory Authority or other governmental agency issues or requests a Recall or takes similar action in connection
    with a Product in the Territory, or if LANNETT reasonably determines after consultation with ELITE that an event has occurred which
    may result in the need for a Recall, the Party notified of or wishing to implement such Recall shall, within forty-eight (48) hours
    (regardless of weekday, weekend or holiday), advise the other Party thereof by telephone or facsimile, after which the Parties shall
    promptly discuss and work together to effect an appropriate course of action. ELITE shall be responsible for notifying the Regulatory
    Authorities in the Territory of any voluntary Recall and implementing any Recalls. LANNETT shall fully cooperate with ELITE to fully
    implement any Recall. ELITE agrees to forward to LANNETT a copy of any field communication associated with the Products that it plans
    to issue before such communication is issued or sent to any governmental agency. ELITE will maintain complete and accurate records
    of any activities conducted with respect to any Recall for such period as may be required by Law. Following any Recall, ELITE will
    review all of its procedures as impacted by the identified root cause in the associated investigation, and will revise such procedures,
    as necessary, to correct the cause of such Recall subject to the change control requirements set forth in the Quality Agreement.
    ELITE will provide LANNETT with such information regarding such review and revisions as LANNETT may request and ELITE shall provide
    LANNETT the right to approve, reject or request modifications to the proposed changes.
	 	 
	7.2	Recall
    Expenses. If a Recall results from the acts or omissions of one Party, then such Party shall bear the full expenses of both Parties
    incurred in the Recall. For clarity, if a Recall is due to a defect during the manufacture, processing, packaging or labelling of
    the Product prior to delivery, the cost and expense shall be borne solely by ELITE. If a Recall is partially caused by the actions
    or omissions of both Parties, then each Party shall be responsible for its proportionate share of the Recall expenses based on its
    proportionate share of causation. Recall expenses include the expenses of notification, shipping, return, replacement (if possible),
    customer fees and penalties, and destruction of recalled Products (including Products which cannot be shipped due to the condition
    causing the Recall). The Parties shall discuss in good faith and agree on the scope and costs of Recall, if practicable, prior to
    enforcement of the Recall.
	 	 
	7.3	Notice
    of Failure to Meet Specifications. If ELITE discovers that there is a potential that any batch or lot of the Products already
    delivered to LANNETT may fail to conform to the Specifications, then ELITE shall notify LANNETT within twenty-four (24) hours (or
    one (1) business day), of such determination of failure to meet the Specifications and of the nature thereof in detail, including,
    but not limited to, supplying LANNETT with all investigatory reports, data and communications, out-of-specification reports and data
    and the results of all outside laboratory testing and conclusions, if any. ELITE shall investigate all such failures promptly, and
    at its sole expense, cooperate with LANNETT in determining the cause for the failure and a corrective action to prevent future failures.

 

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ARTICLE
8 - TERM & TERMINATION

 

	8.1	Term.
    This Agreement shall commence upon the Effective Date, and, unless terminated earlier in accordance with the provisions hereof, shall
    continue for a period of three (3) years from the Effective Date (“Initial Term”). Unless earlier terminated pursuant
    to this Agreement, the Initial Term may be extended for successive one (1) year periods (“Renewal Term”) upon
    mutual agreement of the Parties in writing. The Initial Term and all Renewal Term (if any) are collectively referred to as the “Term.”
	 	 	 
	8.2	Termination.
    If any one or more of the following events of default shall occur, then this Agreement may be terminated as set forth herein:
	 	 	 
	 	 	(a)	if
    a Party files a petition in bankruptcy or is adjudged as bankrupt, or a petition in bankruptcy is filed against it and is not dismissed
    within sixty (60) days, or it becomes insolvent, takes advantage of legislation for creditor relief, has a receiver or receiver-manager
    appointed in relation to its assets, or discontinues its business, then the other Party may terminate this Agreement upon delivering
    written notice of termination;
	 	 	 	 
	 	 	(b)	if
    a Party hereto violates or fails to perform any of its material undertakings, agreements, covenants or obligations under this Agreement
    (excluding matters otherwise specifically addressed with a termination right elsewhere in this Agreement) and the failure is not
    remedied within thirty (30) days after written notice from the non-defaulting Party, then the non-defaulting Party may terminate
    this Agreement upon delivering written notice of termination to the breaching Party; provided that if the breaching Party
    is diligently pursuing in good faith the remedy of the breach at the expiration of such thirty (30) day cure period, then such thirty
    (30) day cure period may be extended as reasonably required to effect the cure if agreed to by the non-defaulting Party;
	 	 	 	 
	 	 	(c)	if
    a Party hereto willfully or fraudulently misrepresents any fact, information or report disclosed pursuant to this Agreement and such
    misrepresentation is not cured or remedied within thirty (30) days after the receipt of written notice thereof by the non-defaulting
    Party, then the other Party may terminate this Agreement upon delivering written notice of termination;
	 	 	 	 
	 	 	(d)	if
    a court of competent jurisdiction makes a final determination that the marketing and sale of a Product in the Territory infringes
    the patent or other Intellectual Property Rights in the Territory of a third party and enjoins the marketing and sale of the Product
    in the Territory, and if all rights to appeal have been exhausted or expired, then LANNETT may, upon delivering written notice to
    ELITE, terminate this Agreement with respect to such Product;

 

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	 	 	(e)	by
    ELITE or LANNETT, on a Product by Product basis, if any time after the first twelve (12) months from the first commercial sale, the
    average License Fee paid by Lannett is less than three hundred thousand dollars (US$300,000) for a six (6) month sales period for
    that Product; and
	 	 	 	 
	 	 	(f)	Lannett
    will also have the right to suspend further performance under this Agreement and/or terminate this Agreement in its entirety, without
    liability except for unpaid previously delivered Products, if: (i) ELITE loses any approval(s) from the FDA required to perform its
    obligations under this Agreement; (ii) ELITE or its principals are involved in felonious or fraudulent activities related to Elite’s
    business; or (iii) ELITE is unable to successfully address material deficiencies identified by the FDA that prevent Elite from manufacturing
    Product as a result of an inspection of ELITE’S facility within sixty (60) days after ELITE’S receipt of a deficiency
    notice from the FDA; or (iv) more than three (3) late shipments of the Products occur during any 12-month period during the Term.
    In any such event, LANNETT may terminate this Agreement immediately by written notice to ELITE. For purposes of this Section, a late
    shipment shall mean failure by ELITE to deliver to LANNETT ninety (90) percent (90%) of the Products ordered by LANNETT for delivery
    within twenty (20) days of the date specified for such delivery in the applicable Purchase Order.
	 	 	 	 
	 	 	(g)	If
    at initial commercial launch the Product must be launched at a negative Net Profit (due to market average sales price falling), then
    the parties shall meet and discuss the best path forward to minimize losses. If the best path is not to launch, then the Parties
    agree to share inventory costs for the first batch of finished product that Lannett has purchased at launch according to the agreed
    upon Net Profit split. 

 

	8.3	Other
                                            Termination Rights. In addition to Article 8.2, (i) either Party may terminate
                                            this Agreement pursuant to Articles 14.3 (Assignment without Consent) and 14.5
                                            (Force Majeure), and (ii) LANNETT may terminate this Agreement pursuant to Article
                                            4.4 (Failure to Supply) and Article 9.2(c) (Debarred), and (iii) ELITE may terminate
                                            this Agreement pursuant to Article 9.3(c) (Debarred). LANNETT may terminate this Agreement
                                            for any reason upon providing ELITE with six (6) months written notice.

                                                                               

	8.4	Effect
    of Termination. Upon termination or expiration of this Agreement, the provisions of this Agreement shall continue to apply with
    respect to the Parties’ respective rights and obligations in relation to any Purchase Order made prior to such termination,
    including without limitation ELITE’s obligation to manufacture, release and deliver Products to LANNETT, and LANNETT’s
    obligation to make payment for such Products. If this Agreement is terminated while LANNETT is still in possession of Products (“Remaining
    Products”), ELITE hereby grants LANNETT and its Affiliates a license to promote, market, distribute and sell the Remaining
    Products in the Territory, subject to the License Fees in Article 3.3.
	 	 
	8.5	Survival.
    The expiration or earlier termination of this Agreement shall not relieve either Party hereto from any obligations which accrued
    prior to such expiration or earlier termination, and shall not destroy or diminish the binding force and effect of any of the terms
    and conditions of this Agreement that expressly or by implication come into or continue in effect on or after termination or expiration,
    including ARTICLE 1 - , ARTICLE 5 - , ARTICLE 6 - , ARTICLE 7 - , Section 8.4, ARTICLE 9 - , ARTICLE 11 - , ARTICLE 12 - , Sections
    14.6, and 14.7. Further, the provisions from the Original Agreement that were deemed to survive the termination or expiration
    of that Agreement shall further survive.

 

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ARTICLE
9 - REPRESENTATIONS & WARRANTIES

 

	9.1	Representations
    and Warranties. Each Party represents and warrants to the other Party as follows, which representations and warranties shall
    be true as at the date hereof and throughout the Term of this Agreement:
	 	 	 
	 	 	(a)	it
    has full corporate power and authority and has taken all corporate action necessary to enter into and perform this Agreement; and
	 	 	 	 
	 	 	(b)	this
    Agreement is its legal, valid and binding obligation, enforceable in accordance with the terms and conditions hereof.
	 	 	 	 
	9.2	ELITE General and Supply Warranties.
    ELITE represents and warrants to LANNETT as follows:
	 	 	 
	 	 	(a)	No
    Other Agreements. No contracts, commitments or agreements of any nature exist, and none will be entered into during the Term
    of this Agreement, that impair or inhibit the ability of ELITE to perform its obligations hereunder.
	 	 	 	 
	 	 	(b)	No
    Lawsuits. As of the date hereof there have not been any Claims, lawsuits, arbitrations, legal or administrative or regulatory
    proceedings, charges, or complaints or investigations, by any third party or government authority threatened, commenced, pending
    or proceeding against ELITE, and ELITE has not received any notice thereof, which could prevent ELITE from complying with its material
    obligations under this Agreement.
	 	 	 	 
	 	 	(c)	Debarred.
    Neither ELITE nor any of its officers, directors, or employees or consultants performing services under this Agreement has been or
    is: (1) an individual who has been debarred by the FDA pursuant to 21 U.S.C. § 335a(a) or (b) (“Debarred Individual”)
    from providing services in any capacity to a person that has an approved or pending drug product application with FDA, or an employer,
    employee, or partner of such a Debarred Individual; or (2) a corporation, partnership or association that has been debarred by FDA
    pursuant to 21 U.S.C. § 335a(a) or (b) (“Debarred Entity”) from submitting or assisting in the submission
    of an ANDA, or an employee, partner, shareholder, member, subsidiary, or affiliate of a Debarred Entity; or (3) an employer, employee
    or partner of an individual convicted within the last five years for crimes described in subsections (a) or (b) of Section 306 of
    the FDCA. If and when ELITE becomes aware of any fact that makes or gives rise to make this representation and warranty untrue, ELITE
    shall immediately notify LANNETT in writing and any such breach may result in immediate termination of this Agreement by LANNETT.

 

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	 	 	(d)	Non-Infringement.

	 	 	 	 
	 	(i)	ELITE’s
                                            performance of its obligations hereunder to the best of ELITE’s knowledge does not
                                            and will not infringe any intellectual property rights of a third party.

                                                                                 

	 	(ii)	To
    the best of ELITE’s knowledge no patents, patent applications if issued, or any other proprietary rights of any third party
    would be infringed by the manufacture, use or sale of the Product and ELITE shall indemnify, defend and hold harmless LANNETT and
    its Affiliates against any and all such infringement claims, demands, actions, losses, damages, fines, penalties, costs and expenses
    (including reasonable attorneys’ fees). The indemnification obligation of ELITE shall include Third Party patents issued after
    the Effective Date.
	 	 	 
	 	 	(e)	Facility.
    The Facility is in compliance with all Laws, including without limitation GMP, and that there are no, nor have been any, citations
    or adverse conditions of a material nature noted in any inspection of the site which would cause the Product to be misbranded or
    adulterated. It has and shall maintain sufficient knowledge and experience and adequate production facility(s), equipment and processes
    to produce the Product and perform its obligations under this Agreement in compliance with all Laws.
	 	 	 	 
	 	 	(f)	Products
    Supply. ELITE warrants, represents and covenants to LANNETT that all Products delivered to LANNETT hereunder shall:

 

	 	(i)	comply
    with the Specifications;
	 	 	 
	 	(ii)	comply
    with the applicable Purchase Order;
	 	 	 
	 	(iii)	be
    manufactured, tested, packaged, labeled, stored, handled and delivered by ELITE in accordance with (i) the terms of this Agreement,
    including the Specifications, and the Quality Agreement, (ii) the requirements of the Marketing Authorization, (iii) all applicable
    GMPs and Laws in the Territory, including regulations set forth by the DEA, (iv) all of ELITE’S quality control procedures
    and associated test methods for the Products;
	 	 	 
	 	(iv)	be
    manufactured at the Facility approved by the Regulatory Authorities in the Territory;
	 	 	 
	 	(v)	not
    be adulterated or misbranded under any applicable Laws in the Territory;
	 	 	 
	 	(vi)	have
    at least eighty-five percent (85%) of the Product’s shelf-life remaining at the time of delivery; and
	 	 	 
	 	(vii)	be
    free of all liens, security interests, and other claims of any nature and free from defects in material, manufacturing and workmanship
    for the shelf-life of the Products.
	 	 	 
	 	 	(g)	be
    manufactured, supplied, packaged, labeled and delivered in compliance with all serialization and aggregation requirements set forth
    in the Drug Supply Chain Security Act (DSCSA) Marketing Authorizations. The serialization requirements include, but are not limited
    to, the addition of Product identifiers imprinted on each sellable unit, on each homogenous case and on each pallet intended to be
    introduced in the Territory. Unique Product identifiers will include a national drug code, serial identifier (proved by LANNETT),
    lot number and expiration date. Serial numbers must be aggregated from item to case and case to pallet. ELITE warrants, represents
    and covenants to LANNETT that (i) all Marketing Authorizations have been obtained as necessary to permit LANNETT to manufacture,
    use, store, import, transport and sell the Product in the Territory pursuant to the terms of this Agreement and (ii) ELITE shall
    maintain all necessary Marketing Authorizations in good standing to permit LANNETT to manufacture, use, store, import, transport
    and sell the Product in the Territory pursuant to the terms of this Agreement.

 

    	17

     

    

 

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                                            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 

 

	 	 	(h)	It
    is and shall at all times relevant to this Agreement be in full compliance with all applicable Laws relating or impacting in the
    performance of ELITE’s duties and obligations under this Agreement, including but not limited to, those rules, regulations,
    and/or guidance promulgated or issued by the FDA, the Centers for Medicare & Medicaid Services, the U.S. Department of Health
    and Human Services Office of Inspector General the U.S. Drug Enforcement Agency, the U.S. Department of Justice, as well as any applicable
    environmental requirements and all serialization and aggregation requirements set forth in the Drug Supply Chain Security Act.
	 	 	 	 
	 	 	(i)	Subject
    to DEA quotas, it has access to sufficient supplies of raw materials, components and other required resources to perform the services
    required under this Agreement, and shall exercise commercially reasonable and diligent efforts to maintain access to sufficient supplies
    without interruption during the Term.

 

	9.3	LANNETT
    General Warranties. LANNETT represents and warrants to ELITE that:

 

	 	 	(a)	No
    Other Agreements. No contracts, commitments or agreements of any nature exist, and LANNETT covenants that none will be entered
    into during the Term of this Agreement that impair or inhibit the ability of LANNETT to perform its obligations hereunder.
	 	 	 	 
	 	 	(b)	No
    Lawsuits. As of the date hereof there have not been any Claims, lawsuits, arbitrations, legal or administrative or regulatory
    proceedings, charges, or complaints or investigations by any third party or government authority threatened, commenced, pending or
    proceeding against LANNETT, and LANNETT has not received any notice thereof, which could prevent LANNETT from complying with its
    material obligations under this Agreement.
	 	 	 	 
	 	 	(c)	Debarred.
    Neither LANNETT nor any of its officers, directors, or employees or consultants performing services under this Agreement has been
    or is: (1) a Debarred Individual or an employer, employee, or partner of such a Debarred Individual; or (2) a Debarred Entity, or
    an employee, partner, shareholder, member, subsidiary, or affiliate of a Debarred Entity; or (3) an employer, employee or partner
    of an individual convicted within the last five years for crimes described in subsections (a) or (b) of Section 306 of the FDCA.
    If and when LANNETT becomes aware of any fact that makes or gives rise to make this representation and warranty untrue, LANNETT shall
    immediately notify ELITE in writing and any such breach may result in immediate termination of this Agreement by ELITE.

 

    	18

     

    

 

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 (I)
NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED 

 

	 	 	(d)	It
    is and shall at all times relevant to this Agreement be in full compliance with all applicable Laws relating or impacting in the
    performance of LANNETT’s duties and obligations under this Agreement, including, to the extent applicable, but not limited
    to, those rules, regulations, and/or guidance promulgated or issued by the FDA, the Centers for Medicare & Medicaid Services,
    the U.S. Department of Health and Human Services Office of Inspector General the U.S. Drug Enforcement Agency, the U.S. Department
    of Justice, as well as any applicable environmental requirements and all applicable requirements set forth in the Drug Supply Chain
    Security Act.

 

	9.4	Disclaimer.
    EXCEPT FOR THE WARRANTIES AND REPRESENTATIONS PROVIDED OR REFERENCED IN THIS AGREEMENT, THE PARTIES MAKE NO OTHER WARRANTIES OR REPRESENTATIONS
    TO EACH OTHER, EXPRESS OR IMPLIED, INCLUDING THOSE WITH RESPECT TO THE PRODUCTS, WHETHER STATUTORY OR OTHERWISE, AND EACH PARTY SPECIFICALLY
    DISCLAIMS ALL OTHER WARRANTIES, INCLUDING ANY IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.

 

ARTICLE
10 - COVENANTS

 

	10.1	Compliance.
    Each Party shall perform its obligations under this Agreement in strict compliance with all applicable GMPs and Laws in the Territory,
    and all applicable licenses, governmental permits or applications in the Territory.
	 	 
	10.2	Permits
    and Licenses. Each Party shall throughout the Term of this Agreement obtain and maintain any and all licenses, permits, orders,
    applications and consents (including facility licenses and permits) required by the Regulatory Authorities in the Territory, and
    all applicable Laws, regulations and GMPs necessary or required to perform its obligations under this Agreement.

 

ARTICLE
11 - INDEMNIFICATION & INSURANCE

 

 

	11.1	Indemnification
    of ELITE. LANNETT shall defend, indemnify and hold harmless ELITE, its Affiliates and their respective officers, directors, employees,
    agents and representatives from and against all Losses from any Third-Party Claim directly resulting from:
	 	 	 
	 	 	(a)	any
    breach of any obligations, actions, or representations made by LANNETT under this Agreement; and
	 	 	 	 
	 	 	(b)	any
    negligent, grossly negligent or intentionally wrongful act or omission of LANNETT or of any person acting on LANNETT’s behalf,
    with authorization, when the wrongful act or omission occurred in performance of LANNETT’s obligations under this Agreement;
	 	 	 	 
	 	provided,
    however, that the foregoing indemnification obligations shall not apply to the extent such Losses are caused by an act or omission
    for which ELITE is contributorily negligent and/or otherwise required to indemnify LANNETT under Article 11.2.

 

    	19

     

    

 

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 (I)
NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED 

 

	11.2	Indemnification
    of LANNETT. ELITE shall defend, indemnify and hold harmless LANNETT, its Affiliates and their respective officers, directors,
    employees, agents and representatives from and against all Losses from any Third-Party Claim directly resulting from:
	 	 
	 	 	(a)	any
    breach of any obligations, actions, or representations made by ELITE under this Agreement; 
	 	 	 	 
	 	 	(b)	any
    infringement or claim of infringement of any patent, trademark or other intellectual property rights based on the manufacture and
    release of the Product furnished under the provisions of this Agreement; 
	 	 	 	 
	 	 	(c)	personal
    injury (including death) or property damage relating to or arising out of any use, distribution or sale of the Products by LANNETT
    or its Affiliates to the extent that such Loss was the result of the Product not being manufactured to meet the Analytical Specifications;
    
	 	 	 	 
	 	 	(d)	any
    negligent, grossly negligent or intentionally wrongful act or omission of ELITE or of any person acting on ELITE’s behalf,
    with authorization, when the wrongful act or omission occurred in performance of ELITE’ obligations under this Agreement;
	 	 	 	 
	 	 	(e)	the
    condition of any Products sold, supplied or delivered to LANNETT under this Agreement, including any defect in material, workmanship,
    design, manufacturing or formulary;
	 	 	(f)	any
    warnings and instructions, or lack thereof, for any Product; 
	 	 	 	 
	 	 	(g)	the
    possession, distribution, sale and/or use of, or by reason of the seizure of, any Product; and
	 	 	 	 
	 	 	(h)	any
    actual or asserted violation(s) of the FDCA or any applicable Law by virtue of which any Product sold, supplied or delivered to Lannett
    under this Agreement is alleged or determined to be adulterated, misbranded, mislabeled or otherwise not in full compliance with,
    or in contravention of, any applicable Law.
	 	 	 	 
	 	provided,
    however, that the foregoing indemnification obligations shall not apply to the extent such Losses are caused by an act or omission
    for which LANNETT is contributorily negligence or is required to indemnify ELITE under Article 11.1. ELITE shall also indemnify
    LANNETT for any damages arising from any interruption in supply of the Products to LANNETT occasioned by ELITE’s commitments,
    contractual or otherwise, with a Third Party subject to Article 4.4.

 

	11.3	Indemnification
    Procedure. Any Party entitled to indemnification hereunder (the “Indemnitee”) shall notify the indemnifying
    Party (the “Indemnitor”) promptly of any claim threatened or commenced against the Indemnitee. The Indemnitor
    shall assume control and direct the defense, investigation and handling of the claim for and on behalf of the Indemnitee, provided,
    however that the Indemnitor shall not settle or consent to judgment without the Indemnitee’s approval, which approval shall
    not to be unreasonably withheld. The Indemnitee shall cooperate with the Indemnitor, and may participate, at the Indemnitee’s
    expense, in the defense of such claim. If the Indemnitor fails to assume control of the defense of any claim, or, having elected
    to assume control, thereafter fails to diligently defend the claim, the Indemnitee shall, without limitation to the Indemnitor’s
    obligations hereunder, be entitled to contest, settle or pay the amount of the claim, and the Indemnitor shall be bound by the results
    obtained by the Indemnitee with respect to the claim.

 

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NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED 

 

	11.4	Insurance.
    Each Party hereby represents to the other that it has, and during the Initial Term and any Renewal Term and for three (3) years after
    termination or expiration of this Agreement, will maintain, products liability insurance coverage of not less than US five million
    dollars ($5,000,000.00) per occurrence and five million dollars ($5,000,000) in the aggregate. For the sake of clarity, should ELITE
    increase its product liability insurance coverage beyond this amount, the new levels shall automatically apply to this Agreement.
    Upon the request of the other Party hereto, the insured Party shall furnish the other Party with a certificate of insurance evidencing
    such coverage and each Party shall endeavor to provide notice to the other Party if there is a material change or cancellation of
    the policy. Each Party shall list the other Party as an additional insured on such Party’s applicable insurance coverage. Each
    Party shall provide the certificate of insurance within ten (10) days of its receipt of a request for proof of insurance.
	 	 
	11.5	Survival.
    The obligations set forth in this ARTICLE 11 - shall survive the termination of this Agreement and remain in full force and
    effect for an indefinite period after termination in relation to any claim based on events which occur during the term hereof.

 

ARTICLE
12 - CONFIDENTIALITY

 

	12.1	Confidentiality.
    During the Term of this Agreement and for five (5) years thereafter, each Party shall maintain in strict confidence the Confidential
    Information (as defined below) of the other Party. Each Party shall not use the Confidential Information of the other Party for any
    purpose other than the purposes expressly permitted by this Agreement and shall not disclose such Confidential Information to any
    third party (including in connection with any publications, presentations or other disclosures) except to its employees, agents or
    advisors (“Representatives”) who have a need to know such Confidential Information to perform such Party’s
    obligations under this Agreement. Each Party shall ensure that any Representative to whom it discloses the other Party’s Confidential
    Information is informed of the confidential nature of and duty not to disclose the information and is obligated under written obligation
    to maintain the confidentiality thereof on terms at least as restrictive as those set forth herein. Each Party shall be responsible
    for any breach of this Agreement by its Representatives, which shall be considered a breach by such Party. Under no circumstances
    shall the receiving Party use the disclosing Party’s Confidential Information for its own commercial advantage to the detriment
    of the disclosing Party. Each Party may disclose such of the Confidential Information of the other Party as may be required by the
    order of a court of competent jurisdiction or by any governmental authority having jurisdiction, provided that prior to any
    such disclosure the Party required to disclose shall, to the extent permitted by Law, notify the other Party prior to disclosing
    any Confidential Information and provide such other Party with a reasonable opportunity to contest or limit the scope of the required
    disclosure and obtain any protective orders as may be appropriate. In the event the disclosure is nonetheless compelled, the Party
    making the disclosure shall only disclose the information to the extent required to comply with the Law. Upon termination or expiration
    of this Agreement, or upon request, a Party shall destroy or return all Confidential Information of the other Party and certify in
    writing that such return (or destruction) has been completed; provided, however, that each Party shall be entitled to retain one
    archival copy of such Confidential Information solely for purposes of monitoring such Party’s compliance with its obligations
    under this ARTICLE 12 - . 

 

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 (I)
NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED 

 

	12.2	Definition.
    “Confidential Information” means all proprietary technical information, marketing, business and financial information,
    scientific data, information, whether or not labeled “Confidential”, and all tangible and intangible embodiments and
    oral disclosures thereof of any kind whatsoever, and all other materials which a disclosing Party treats confidentially that relates
    to a Product or the business of a Party and is disclosed or developed under or in connection with this Agreement. Confidential Information
    shall not include any information which the receiving Party can show by competent proof:
	 	 
	 	 	(a)	was
    known to or in the possession of the receiving Party prior to the date of its actual receipt from the disclosing Party; 
	 	 	 	 
	 	 	(b)	is
    readily available to the public other than through the fault of the receiving Party; 
	 	 	 	 
	 	 	(c)	was
    disclosed by a third party not under an obligation of confidentiality to the disclosing Party; or 
	 	 	 	 
	 	 	(d)	is
    subsequently independently developed by the receiving Party without use of the Confidential Information as demonstrated by competent
    written records.
	 	 	 	 
	12.3	Injunctive
    Relief. The Parties acknowledge that any breach of this ARTICLE 12 -  may constitute irreparable harm, and that the
    non-breaching Party shall be entitled to seek specific performance or injunctive relief to enforce this ARTICLE 12 -  in
    addition to whatever remedies such Party may otherwise be entitled to at law or in equity, without the necessity of posting bond
    or any other security.
	 	 
	12.4	Separate
    Confidentiality Agreement. LANNETT and ELITE have entered into a separate Mutual Confidential Disclosure Agreement dated January
    7, 2019 (“Confidentiality Agreement”). Such Confidentiality Agreement will be and remain in full force and effect
    as provided therein. In the event of any conflict between the terms of this Agreement and the terms of any such Confidentiality Agreement,
    the terms of such Confidentiality Agreement will control. 
	 	 
	12.5	No Publicity.
    Except as required by law, neither Party shall originate any publicity, news release or other public announcements, written or
    oral, whether to the public press, to stockholders, or otherwise, relating to this Agreement, any amendment hereto, performance hereunder
    or the existence of an arrangement between the Parties without the prior written approval of the other Party, which approval shall
    not be unreasonably withheld. Nothing in the provision shall be deemed to prevent a Party from making such disclosures or announcements
    that are legally required of such Party; provided that in any event the non-disclosing Party shall have the right to review
    any such disclosure and revise such disclosure to the extent it relates to the use of the non-disclosing Party’s name or Confidential
    Information. No Party shall, without the prior written consent of the affected Party, use in advertising, publicity, or otherwise,
    the name, trademark, logo, symbol, or other image of the affected Party without the other Party’s prior written consent. 
	 	 
	ARTICLE
                                            13 - REGULATORY MATTERS

                                                                                 

	13.1	 	Regulatory
    Responsibilities. ELITE will, at its own cost and expense, continue to own and maintain the applicable Regulatory Approvals necessary
    to market the Products in the Territory. ELITE shall be responsible for all regulatory and safety reporting requirements associated
    with ownership of the Regulatory Approval, including, without limitation, adverse event reports, annual reports mandated by the applicable
    Laws in the Territory. Additionally, ELITE shall be responsible for complying with applicable Laws to appropriately categorize and
    report changes to the FDA, including without limitation, amendments, supplements, and annual reports. All communications by ELITE
    with the FDA relating to the Products as marketed in the Territory shall be promptly provided in writing to LANNETT, and ELITE shall
    promptly provide to LANNETT copies of all documents sent to or received from the FDA regarding the Products. 

 

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NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED 

 

	13.2	Labeling.
    ELITE shall be responsible for the creation, content, and printing of the labeling for the Products. ELITE shall send LANNETT all
    labeling materials (e.g., package insert, container label, carton label, medication guide, patient labeling, etc.) in final format
    for the Products for LANNETT’S review and final written approval. ELITE is responsible for ensuring the most current labeling
    content, consistent with the reference listed drug (“RLD”) labeling content and all requested FDA updates, is used on
    Products supplied to LANNETT. ELITE is responsible for notifying LANNETT within three (3) business days of any FDA communication
    requesting changes to labeling materials, including Safety Change Notifications and changes requested per section 505(o)(4) of the
    FDCA. ELITE will provide LANNETT with a copy of all FDA communications related to labeling. All changes to labeling materials for
    the Products require LANNETT’S review and final written approval. Labeling materials that have not been subject to LANNETT’S
    review and written approval are prohibited to be used on Products supplied to LANNETT. ELITE is responsible for submitting the content
    of labeling in Structured Product Labeling (“SPL”) format to the FDA for LANNETT’S NDC numbers within fourteen
    (14) days of ANDA approval to ensure proper drug listing. ELITE is also responsible for submitting updated SPL files within fourteen
    (14) days when labeling changes are made and approved and as required by applicable Laws.
	 	 
	ARTICLE
    14 - MISCELLANEOUS
	 
	14.1	Notices.
    Any notice or other document required or permitted to be given pursuant to this Agreement shall be in writing and shall be delivered
    by personally by hand; by courier; by prepaid certified mail, return receipt requested; or by email, in each case addressed to the
    Party to whom it is to be given at the address set forth below or at such other address as the Party to whom such notice is to be
    given shall have last notified the other Party in accordance with the provisions of this section:

 

	In
    the case of LANNETT at:	Lannett
    Company, Inc., USA
	 	1150
    Northbrook Drive 
	 	Suite
    155
	 	Trevose,
    PA 19053
	 	Attention:
    Legal Department
	 	Email:
    ***@lannett.com
	And
    in the case of ELITE at:	Elite
    Pharmaceuticals, Inc. 
	 	165
    Ludlow Avenue
	 	Northvale,
    NJ 07647
	 	Attention:
    CEO
	 	Email:
    ***@elitepharma.com

 

	 	Any
    such notice or other document shall:
	 	 
	 	(i)	if
    delivered by hand, courier, or email be deemed to have been given and received at the place of receipt on the date of delivery, provided
    that if delivery is other than during business hours (9:00 a.m. to 5:00 p.m., local time) on a Business Day in the place of receipt,
    such notice shall be deemed to have been given and received at the place of receipt on the first Business Day thereafter; and

 

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NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED 

 

	 	(ii)	if
    mailed, be deemed to have been given and received at the place of receipt on the earlier of the date of actual receipt and three
    (3) Business Days after the date of mailing. In the event of postal disruption, such notices or documents must be delivered
    by means other than by mail.

 

	14.2	Relationship
    of the Parties. The relationship of the Parties is that of independent contractors. Nothing in this Agreement shall be deemed
    or construed to constitute or create between the Parties hereto a partnership, joint venture, agency, or other relationship other
    than as expressly set forth herein. This Agreement does not constitute any one Party hereto as the agent or legal representative
    of the other Party for any purpose whatsoever. Neither of the Parties grants to the other any right or authority to assume or create
    any obligation or responsibility, express or implied, on behalf of it or in its name in any manner whatsoever, unless otherwise agreed
    to in writing by the other Party.
	 	 
	14.3	Inurement
    & Assignment. This Agreement shall be binding upon and inure to the benefit of the Parties hereto and their respective successors
    and permitted assigns. Except as otherwise expressly provided herein, neither Party may assign or transfer it rights or obligations
    under this Agreement, in whole or in part, without the prior written consent of the other Party. Notwithstanding the foregoing, both
    LANNETT and ELITE shall be entitled to assign its rights and performance of its obligations under this Agreement to any Affiliate
    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), provided that the assigning Party remains fully responsible for the performance
    of the obligations of its Affiliates under this Agreement. Any assignment or transfer by a Party other than in accordance with the
    terms hereof shall be void and shall entitle the other Party to terminate this Agreement.
	 	 
	14.4	No
    Waiver; Remedies. No Party to this Agreement shall be deemed or taken to have waived any provision of this Agreement unless such
    waiver is in writing, and then such waiver shall be limited to the circumstances set forth in such written waiver. No failure or
    delay on the part of a Party in exercising any right, power or remedy shall operate as a waiver thereof, nor shall any single or
    partial exercise of any such right, power or remedy preclude any other or further exercise thereof or the exercise of any other right,
    power or remedy. All remedies provided for hereunder shall be cumulative of and in addition to any and all other remedies, at law
    or in equity, which any Party may have, and the exercise of any one or more of such remedies shall not preclude the exercise of any
    others.
	 	 
	14.5	Force
    Majeure. If either Party is prevented from complying, either totally or in part, with any of the terms or provisions of this
    Agreement by reason of force majeure, including fire, flood, earthquake, storm, general strike, lockout, riot, war, terrorism, rebellion,
    accident, acts of God and/or any other cause or externally induced similar casualty beyond its reasonable control and without the
    fault or negligence of either Party(a “Force Majeure Event”), then, upon written notice by the Party liable to
    perform to the other Party, the requirements of this Agreement or such of its provisions as may be affected, and to the extent so
    affected, shall be suspended during the period of such disability, provided that the Party asserting force majeure shall bear
    the burden of establishing the existence of such Force Majeure Event by clear and convincing evidence, and provided further
    that the Party prevented from complying shall use its best efforts to remove such disability, and shall continue performance with
    the utmost dispatch whenever such causes are removed, and shall notify the other Party of the Force Majeure Event not more than five
    (5) Business Days from the time of the event and state the nature of the Force Majeure Event, its anticipated duration and any action
    being taken to avoid or minimize its effect. The suspension of performance shall be of no greater scope and no longer duration than
    is reasonably required. When such circumstances arise, the Parties shall discuss what, if any, modification of the terms of this
    Agreement may be required in order to arrive at an equitable solution. Notwithstanding the foregoing, if a Force Majeure Event shall
    continue for a period of longer than three (3) consecutive months or one hundred and twenty (120) days in any twelve (12) month period,
    then the Party unaffected by such event may terminate this Agreement immediately upon giving written notice of termination to the
    other Party. Notwithstanding any provision contained herein, any action taken by a Regulatory Authority as a result of a Party’s
    negligence or willful misconduct shall not constitute a Force Majeure Event under this Article 14.5.

 

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NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED 

 

	14.6	Dispute
    Resolution. The Parties recognize that disputes as to certain matters may from time to time arise which relate to a Party’s
    rights and/or obligations under this Agreement. It is the objective of the Parties to establish procedures to facilitate the resolution
    of such disputes in an expedient manner by mutual cooperation and without resort to litigation. To accomplish this objective, the
    Parties agree to follow the procedures set forth in this Article 14.6 if and when such a dispute arises between the Parties
    arises. Notwithstanding the provisions of this Article 14.6 however, nothing herein contained shall preclude a Party from
    seeking equitable remedies in any court of competent jurisdiction as set forth in Article 14.7 hereof. If any controversy,
    dispute or claim arises between the Parties relating to the interpretation, breach, performance, enforcement, termination or validity
    of this Agreement and the Parties cannot resolve the dispute within thirty (30) days of a written request by one Party to any other
    Party, the Parties agree to hold a meeting, attended by each Parties authorized representatives , to attempt in good faith to negotiate
    a resolution of the dispute prior to pursuing other available remedies. If, within thirty (30) days after such written request, the
    Parties have not succeeded in negotiating a resolution of the dispute, the Party may seek any other remedies available to it in at
    law or in equity.
	 	 
	14.7	Governing
    Law & Venue. This Agreement shall be governed by, and construed in accordance with, the laws of the State of Delaware, without
    giving effect to any choice of law or conflict of law rules or provisions that would cause the application of the laws of any jurisdiction
    other than the State of Delaware. Each Party hereby irrevocably submits to the exclusive jurisdiction of any federal or state court
    in Delaware for the purposes of any suit, action or other proceeding arising out of this Agreement or any transaction contemplated
    hereby. Each Party further agrees that service of any process, summons, notice or document by certified or registered mail to such
    Party’s address set forth in Article 14.1 or such other address or to the attention of such other person as the recipient
    Party has specified by prior written notice to the sending Party shall be effective service of process in any action, suit or proceeding
    in Delaware with respect to any matters to which it has submitted to jurisdiction as set forth above in the immediately preceding
    sentence. Each Party irrevocably and unconditionally waives any objection to the laying of venue of any action, suit or proceeding
    arising out of this Agreement or the transactions contemplated hereby in the federal or the state courts in Delaware and hereby irrevocably
    and unconditionally waives and agrees not to plead or claim in any such court that any such action, suit or proceeding brought in
    such court has been brought in an inconvenient forum.
	 	 
	14.8	Waiver
    of Trial by Jury. TO THE FULLEST EXTENT PERMITTED BY LAW, THE PARTIES HEREBY WAIVE THEIR RESPECTIVE RIGHTS TO A JURY TRIAL OF
    ANY PROCEEDING BASED UPON, ARISING OUT OF, OR RELATED TO THIS AGREEMENT, INCLUDING ANY DISPUTE ARISING OUT OF OR RELATING TO THE
    PERFORMANCE THEREOF, OR ANY OF THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT. THE SCOPE OF THIS WAIVER IS INTENDED TO BE ALL-ENCOMPASSING
    OF ANY AND ALL DISPUTES THAT MAY BE FILED IN ANY COURT AND THAT RELATE TO THE SUBJECT MATTER OF THIS AGREEMENT, INCLUDING CONTRACT
    CLAIMS, TORT CLAIMS, BREACH OF DUTY CLAIMS AND ALL OTHER COMMON LAW AND STATUTORY CLAIMS.

 

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NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED 

 

	14.9	Severability.
    If any provision in this Agreement is held to be invalid, void or unenforceable, then the remainder of this Agreement, or the application
    of such provision to the Parties or to the circumstances other than those as to which it is held invalid or unenforceable, shall
    not be affected thereby and shall be enforced to the fullest extent permitted by law. The Parties agree to renegotiate any such invalid,
    void or unenforceable provision in good faith in order to provide a reasonably acceptable alternative consistent with the basic purposes
    of this Agreement.
	 	 
	14.10	Entire
    Agreement. This Agreement (including the Schedules attached hereto, the SDEA and the Quality Agreement) constitutes the
    entire agreement between the Parties with respect to the subject matter hereof, and all prior or agreements, whether written or oral,
    are superseded hereby. This Agreement may be amended only in writing executed by the Parties.
	 	 
	14.11	Sub-contracting.
    ELITE shall not sub-contract any of the work to be performed under this Agreement without the prior written consent of LANNETT. No
    such sub-contracting shall relieve ELITE of any of its obligations hereunder.
	 	 
	14.12	Counterparts.
    This Agreement may be executed in any number of counterparts, each of which when so executed shall be deemed to be an original and
    all of which when taken together shall constitute this Agreement. 
	 	 
	14.13	Headings.
    The captions and headings contained herein are for convenience of the Parties and in no way define, limit or describe the scope of
    this Agreement.
	 	 
	14.14	Language.
    The language of this Agreement and all proceedings taken in relation thereto shall be English.
	 	 
	14.15	Currency.
    Unless otherwise specifically provided, all references to money amounts are expressed in terms of United States Dollars (USD) and
    all payments made pursuant to this Agreement shall be made in that currency.
	 	 
	14.16	Section
    365(n) of the Bankruptcy Code. All rights and licenses granted under or pursuant to any Section of this Agreement are and shall
    otherwise be deemed to be for purposes of Section 365(n) of Title 11, of the United States Code (the “Bankruptcy Code”)
    licenses of rights to “intellectual property” as defined in Section 101(35A) of the Bankruptcy Code. The Parties shall
    retain and may fully exercise all of their respective rights and elections under the Bankruptcy Code. Upon the bankruptcy of any
    Party, the non-bankrupt Party shall use its best efforts to transfer its Product responsibilities to a third party, unless the bankrupt
    Party elects to continue, and continues, to perform all of its obligations under this Agreement.
	 	 
	14.17	Construction
    of Agreement. The terms and provisions of this Agreement represent the results of negotiations between the Parties and their
    representatives, each of which has been represented by counsel of its own choosing, and neither of which has acted under duress or
    compulsion, whether legal, economic or otherwise. Accordingly, the terms and provisions of this Agreement shall be interpreted and
    construed in accordance with their usual and customary meanings, and each of the Parties hereto hereby waives the application in
    connection with the interpretation and construction of this Agreement of any rule of law to the effect that ambiguous or conflicting
    terms or provisions contained in this Agreement shall be interpreted or construed against the Party whose attorney prepared the executed
    draft or any earlier draft of this Agreement.

 

[SIGNATURE
PAGE FOLLOWS]

 

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 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 

 

IN
WITNESS WHEREOF, the Parties hereto have executed this Agreement as of the date first written above.

 

	ELITE
    PHARMACEUTICALS, INC.	 	LANNETT
    COMPANY, INC.
	 	 	 
	By:	                            	 	By:	             
	Name:		 	Name:	
	Title:		 	Title:	

 

ELITE
LABORATORIES, INC.

 

	By:		 
	Name:		 
	Title:		 

 

	Schedule
    A:	Products
    and Prices
	 	 
	Schedule
    B:	Product
    Specifications
	 	 
	Schedule
    C:	Quarterly
    Report for Calculation of Net Profit
	 	 
	Schedule
    D: 	Shipping
    Instructions

 

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 EXPLANATORY
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NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED 

 

SCHEDULE
A

 

Products
and Prices

 

Product
List

 

	Generic
    Name	 	ANDA
    #	 	Reference
    Listed Drug
	Vigabatrin		214961		Sabril®,
    Lundbeck Pharmaceuticals

 

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 EXPLANATORY
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NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED 

 

Transfer
Prices ($/carton)

 

	Name	 	Strength	 	Full
    Batch Qty. (cartons)	 	Carton
    Size	 	Cost
    per carton	 
	Vigabatrin	 	500 mg	 	2,500 cartons	 	50 packets	 	$	**.00	

 

The
Transfer Price for the Product is the cost of goods sold and means the fully burdened cost of manufacturing a Product, which consists
of the direct and indirect costs associated with acquiring the materials, including the manufacturing, testing and analysis of the finished
dosage of a Product, quality control, quality assurance, labeling, and packaging, labor (including benefits), serialization, annual generic
drug user fees (GDUFA), depreciation and overhead, all determined in accordance with GAAP and is subject pricing adjustments in Section
4.1(d).

 

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 (I)
NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED 

 

Schedule
B

 

Product
Specifications

 

 

    	30

     

    

 

 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 

 

 

    	31

     

    

 

 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 

 

Schedule
C

 

Quarterly
Report for Calculation of NET Profit

 

Product
Name:________________________________________________________

 

	Quantity
    sold by SKU	 	XXXX
    units	 
	Gross
    Sales	 	$	          	 
	Deductions:	 	 	 	 
	Chargebacks	 	 	 	 
	Rebates	 	 	 	 
	ADministrative
    Fees	 	 	 	 
	Billbacks	 	 	 	 
	Returns	 	 	 	 
	Shelf
    Stock Adjustments	 	 	 	 
	Other
    deductions	 	 	 	 
	Cash
    Discounts	 	 	 	 
	Medicaid	 	 	 	 
	NET
    SALES	 	$		 
	Transfer
    Price	 	 	 	 
	DIstribution
    FEES	 	 	 	 
	Shipping
    COsts	 	 	 	 
	 	 	 	 	 
	NET
    PROFITS	 	 	 	 
	Profit
    share Payment to ELITe at the applicable Licence fee percentage set forth in Section 3.3	 	 	 	 

 

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 (I)
NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED 

 

SCHEDULE
D

 

SHIPPING
INSTRUCTIONS

 

All
shipments inbound to LANNETT must arrive intact and in a certain and dry condition that is free from defects and damage.

 

All
material must have 85% of its maximum shelf life remaining at the time of delivery and in no case less than 15 months.

 

All
truckloads of the Products should be in sealed trailers, with the seal number noted on the delivery receipt.

 

All
truckload and less than truckload shipments must be on 40”x48” 4-way heat treated pallets that are shrink-wrapped and free
of broken boards.

 

Finished
goods materials should have a maximum height of 51” from the floor to the top of the pallet.

 

Each
shipment must be labelled with a minimum of the name of the material, the manufacturer’s lot number, the gross, tare, and net weights,
the LANNETT item number for the material, and the LANNETT purchase order number.

 

All
finished products must be packaged as agreed in the product specification and case labels must be HDMA complaint.

 

A
dock appointment must be scheduled for deliveries consisting of 5 or more pallets and for all hazardous material. Receiving hours are
7am-3pm Eastern. For Seymour, IN deliveries, please contact the representative at 812-523-5446 to schedule all freight deliveries.

 

Please
email invoices to the following email address: ***@Lannett.com

 

    	33

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