Document:

Exhibit
10.49

 

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 IN PUBLICLY DISCLOSED.

 

 

 

 

 

 

 

 

License,
SUPPLY

and Distribution Agreement

 

FOR
Dantrolene Capsules

 

Elite
pharmaceuticals, inc.,

 

elite
laboratories, inc.,

 

-
and -

 

LANNETT
COMPANY, Inc.

 

Dated
as of April 9, 2019

 

 

 

     

     

    

 

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 IN PUBLICLY DISCLOSED.

 

THIS
LICENSE, SUPPLY AND DISTRIBUTION AGREEMENT is made as of April 9, 2019 (the “Effective Date”), by and between
ELITE PHARMACEUTICALS, INC. a Nevada corporation and ELITE LABORATORIES, INC., 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.

 

    1

     

    

 

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 IN 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 [**] percent ([**]%) 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.

 

    2

     

    

 

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 IN 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):

 

		(i)	Any
                                         and all promotional allowances, rebates, charge backs, quantity and cash discounts, and
                                         other usual and customary discounts to customers;

 

    3

     

    

 

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 IN PUBLICLY DISCLOSED.

 

		(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.

 

    4

     

    

 

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 IN 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.

 

    5

     

    

 

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 IN PUBLICLY DISCLOSED.

 

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 from the date of commercialization of the Products through
                                         June 30, 2020, of [**] percent ([**]%) of the Net Profits received from sales of each
                                         Product. For the year July 1, 2020 through June 30, 2021 and each year thereafter, Lannett
                                         shall pay to Elite a License Fee of either (a) [**] percent ([**]%) of the Net Profits
                                         received from sales of each Product; or (b) if LANNETT receives [**] dollars ($[**])
                                         or more in Net Profits during such year, [**] percent ([**]%) of the Net Profits received
                                         from sales of each Product, with such higher percentage being paid on only such amount
                                         exceeding the [**] dollars ($[**]). 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. In the event
                                         that 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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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 IN PUBLICLY DISCLOSED.

 

		(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, 2019. After December 31, 2019, 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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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 IN PUBLICLY DISCLOSED.

 

		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.

 

    8

     

    

 

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 IN 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 given 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.

 

    9

     

    

 

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 IN
PUBLICLY DISCLOSED.

 

		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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THAT HAS BEEN OMITTED BECAUSE IT IS BOTH
(I) NOT MATERIAL AND

(II) WOULD BE COMPETITIVELY HARMFUL IN
PUBLICLY DISCLOSED.

 

		(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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(I) NOT MATERIAL AND

(II) WOULD BE COMPETITIVELY HARMFUL IN
PUBLICLY DISCLOSED.

 

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.

 

		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.

 

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(I) NOT MATERIAL AND

(II) WOULD BE COMPETITIVELY HARMFUL IN
PUBLICLY DISCLOSED.

  

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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(II) WOULD BE COMPETITIVELY HARMFUL IN
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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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(II) WOULD BE COMPETITIVELY HARMFUL IN
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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.

 

		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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(II) WOULD BE COMPETITIVELY HARMFUL IN
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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.

 

		(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.

 

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(I) NOT MATERIAL AND

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		(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

     

    

 

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 IN
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

     

    

 

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 IN
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

     

    

 

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 IN
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.

 

    20

     

    

 

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 IN
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 - .

 

    21

     

    

 

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 IN
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.

 

    22

     

    

 

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 IN
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

9000 State Road

Philadelphia, PA 19136

Attention: Legal Department

Email: [**]

 

And in the
case of ELITE at:                          Elite Pharmaceuticals, Inc.

165 Ludlow Avenue

Northvale, NJ 07647

Attention: CEO

Email: [**]

 

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

 

		(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.

 

    23

     

    

 

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 IN
PUBLICLY DISCLOSED.

 

		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.

 

    24

     

    

 

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 IN
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.

 

		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.

 

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

 

	ELITE PHARMACEUTICALS, INC.	 	LANNETT COMPANY, INC.
	 	 	 
	By:	/s/
    Nasrat     Hakim	 	By:	/s/
    John     Kozlowski
	Name:	Nasrat
    Hakim	 	Name:	John
    Kozlowski
	Title:	CEO	 	Title:	COSSO

 

ELITE
LABORATORIES, INC.

 

	By:	/s/
    Nasrat     Hakim	 
	Name:	Nasrat
    Hakim	 
	Title:	CEO	 

 

	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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SCHEDULE
A

 

Products
and Prices

 

Product
List

 

	Generic
    Name	 	ANDA
    #	 	Reference
    Listed Drug
	Dantrolene
    Sodium	 	76686	 	Dantrium®,
    Par Sterile Products, LLC

 

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Transfer
Prices ($/bottle)

 

	Name	 	Strength	 	Full Batch Qty.	 	Bottle Size	 	Cost per bottle 
	Dantrolene Sodium	 	25 mg	 	[**] bottles	 	100 count	 	$[**]
	Dantrolene Sodium	 	50 mg	 	[**] bottles	 	100 count	 	$[**]
	Dantrolene Sodium	 	100 mg	 	      [**]	 	100 count	 	$[**]

 

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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Schedule
B

 

Product
Specifications

 

[**]

 

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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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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: AccountsPayable@Lannett.com

 

 

32Exhibit 10.50

 

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License,
SUPPLY

and Distribution Agreement

 

Elite pharmaceuticals,
inc.,

 

elite laboratories,
inc.,

 

- and -

 

LANNETT
COMPANY, Inc.

 

Dated as of March 6, 2019

 

 

 

     

     

    

 

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THIS LICENSE, SUPPLY AND DISTRIBUTION
AGREEMENT is made as of March 6, 2019 (the “Effective Date”), by and between ELITE PHARMACEUTICALS, INC.
a Nevada corporation and ELITE LABORATORIES, INC., 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 and their ANDA co-owner, SunGen Pharma LLC (303C College Road East, Princeton, NJ 08540)
(“SunGen”), have 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.

 

    1

     

    

 

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		(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 [**] percent ([**]%) 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 Ludlow Avenue, Northvale, New Jersey 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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		(v)	“Gross Profit” means the Net Sales of a Product each calendar quarter less Transfer
Price of Product, Distribution Fees and shipping costs from the Facility.

 

		(w)	“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.

 

		(x)	“Indemnitee” has the meaning given in Article 11.3.

 

		(y)	“Indemnitor” has the meaning given in Article 11.3.

 

		(z)	“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.

 

		(aa)	“LANNETT” has the meaning given in the preamble.

 

		(bb)	“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.

 

		(cc)	“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.

 

		(dd)	“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.

 

		(ee)	“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.

 

		(ff)	“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):

 

		(i)	Any and all promotional allowances, rebates, charge backs, quantity and cash discounts, and other
usual and customary discounts to customers;

 

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		(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.

 

		(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.

 

		(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.

 

    4

     

    

 

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		(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)	“SunGen” has the meaning given in the preamble.

 

		(uu)	“Term” has the meaning given in Article 8.1.

 

		(vv)	“Territory” means the United States of America and its possessions, territories,
protectorates, military bases and commonwealths.

 

		(ww)	“Third Party” means any Person other than LANNETT or ELITE or SunGen, or any
of their respective Affiliates.

 

		(xx)	“Trademarks” has the meaning given in Article 4.3(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 and their ANDA co-owner SunGen 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 and their ANDA
co-owner SunGen 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.

 

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.

 

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		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. Throughout the Initial Term and Renewal Term, LANNETT shall pay to ELITE [**] percent
([**]%) of the Gross Profits received from sales of each Product within forty-five (45) days of the end of each calendar quarter
(“License Fees”). 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 Fees 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. In the event that Net Profits for calendar
quarter are negative, LANNETT shall carry over seventy percent ([**]%) of 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 for seventy percent ([**]%) of the value
by which the Net Profits are negative for the previous calendar quarter and carry over seventy percent ([**]%) of 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.

 

		3.4	Lannett shall pay to Elite seven hundred and fifty thousand dollars (US$750,000) upon commercial
launch of the [**] Product.

 

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”).

 

		(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.

 

    6

     

    

 

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 IN
PUBLICLY DISCLOSED.

 

		(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.

 

Transfer Price
Adjustments. The Transfer Prices for the Products under Schedule A are valid through December 31, 2019. After December
31, 2019, 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.

 

		(d)	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.

 

    7

     

    

 

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 IN
PUBLICLY DISCLOSED.

 

		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.

 

		(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.

 

    8

     

    

 

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 IN
PUBLICLY DISCLOSED.

 

		(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 given
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.

 

		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.

 

    9

     

    

 

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 IN
PUBLICLY DISCLOSED.

 

		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.

 

		(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.

 

    10

     

    

 

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 IN
PUBLICLY DISCLOSED.

  

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.

 

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.

 

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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 IN
PUBLICLY DISCLOSED.

  

		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.

 

		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.

 

    12

     

    

 

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 IN
PUBLICLY DISCLOSED.

 

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.

 

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.”

 

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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 IN
PUBLICLY DISCLOSED.

 

		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;

 

		(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.

 

    14

     

    

 

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 IN
PUBLICLY DISCLOSED.

 

		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.

 

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.

 

    15

     

    

 

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 IN
PUBLICLY DISCLOSED.

 

		(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.

 

		(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;

 

    16

     

    

 

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 IN
PUBLICLY DISCLOSED.

 

		(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.

 

		(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.

 

    17

     

    

 

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 IN
PUBLICLY DISCLOSED.

 

		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.

 

		(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.

 

    18

     

    

 

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 IN
PUBLICLY DISCLOSED.

 

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.

 

		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.

 

    19

     

    

 

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 IN
PUBLICLY DISCLOSED.

 

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.

 

		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. ELITE shall increase its product liability insurance coverage to ten million dollars ($10,000,000) prior to the
launch of [**] Product. 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.

 

    20

     

    

 

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 IN
PUBLICLY DISCLOSED.

 

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 - .

 

		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.

 

    21

     

    

 

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 IN
PUBLICLY DISCLOSED.

 

		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.

 

		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.

 

    22

     

    

 

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 IN
PUBLICLY DISCLOSED.

 

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

9000 State Road

Philadelphia, PA 19136

Attention: Legal Department

Email: [**]

 

And in the
case of ELITE at:                          Elite Pharmaceuticals, Inc.

165 Ludlow Avenue

Northvale, NJ 07647

Attention: CEO

Email: [**]

 

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

 

		(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.

 

    23

     

    

 

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 IN
PUBLICLY DISCLOSED.

 

		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.

 

		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.

 

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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 IN
PUBLICLY DISCLOSED.

 

		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.

 

		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.

 

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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 IN
PUBLICLY DISCLOSED.

 

		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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(I) NOT MATERIAL AND

(II) WOULD BE COMPETITIVELY HARMFUL IN
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IN WITNESS WHEREOF, the Parties
hereto have executed this Agreement as of the date first written above.

 

	ELITE PHARMACEUTICALS, INC.	 	LANNETT COMPANY, INC.
	 	 	 
	By:   	/s/ Nasrat Hakim      	     	By: 	/s/ Tim Crew                
	Name: Nasrat Hakim	 	Name: Tim Crew
	Title: CEO	 	Title: CEO

 

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

  

		Schedule A:	Products

 

		Schedule B:	Product Specifications

 

		Schedule C:	Quarterly Report for Calculation of Gross Profit

 

		Schedule D:	Shipping Instructions

 

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SCHEDULE A

 

Products and Prices

 

Product List

 

	Generic Name	 	ANDA #	 	Reference Listed Drug
	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product)	 	211352	 	Adderall® 
	[**]	 	[**]	 	[**]

  

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(I) NOT MATERIAL AND

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Transfer Prices ($/bottle)

 

	
        Name
	 	Strength	 	Full Batch 

Qty.	 	Bottle Size	 	Cost per 

bottle 
	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product)	 	5 mg	 	[**] bottles	 	100 count	 	$[**]
	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product)	 	7.5 mg	 	[**] bottles	 	100 count	 	$[**]
	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product)	 	10 mg	 	[**] bottles	 	100 count	 	$[**]
	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product)	 	12.5 mg	 	[**] bottles	 	100 count	 	$[**]
	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product)	 	15 m g	 	[**] bottles	 	100 count	 	$[**]
	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product)	 	20 mg	 	[**] bottles	 	100 count	 	$[**]
	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product)	 	30 mg	 	[**] bottles	 	100 count	 	$[**]
	[**]	 	[**] mg	 	[**] bottles	 	100 count	 	$[**]
	[**]	 	[**] mg	 	[**] bottles	 	100 count	 	$[**]
	[**]	 	[**] mg	 	[**] bottles	 	100 count	 	$[**]
	[**]	 	[**] mg	 	[**] bottles	 	100 count	 	$[**]
	[**]	 	[**] mg	 	[**] bottles	 	100 count	 	$[**]
	[**]	 	[**] mg	 	[**] bottles	 	100 count	 	$[**]

 

Pricing includes all Product manufacturing
and packaging costs, quality assurance, batch quality control testing and stability testing, and is subject pricing adjustments
in Section 4.1(d).

 

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(I) NOT MATERIAL AND

(II) WOULD BE COMPETITIVELY HARMFUL IN
PUBLICLY DISCLOSED.

  

Schedule
B

 

Product
Specifications

 

[**]

 

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Schedule
C

 

Quarterly
Report for Calculation of Gross 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	 	 
	Gross
    Profit	 	 
	NET
    PROFIT	 	 
	Profit
    share Payment to ELITe at  [**]%	 	 

  

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(I) NOT MATERIAL AND

(II) WOULD BE COMPETITIVELY HARMFUL IN
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: AccountsPayable@Lannett.com

 

 

32

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