Document:

Exhibit 10.56

 

MANUFACTURING AND SUPPLY AGREEMENT

 

This MANUFACTURING AND SUPPLY AGREEMENT
(this "Agreement") is made as of May _, 2011, (the "Effective Date") by and between Mikah Pharma, LLC, organized
and existing under the laws of the State of Delaware, having offices at 20 Kilmer Drive, Hillsborough, New Jersey 08844, (referred
to herein as "Mikah”) and Epic Pharma, LLC, a company organized under the laws of Delaware having offices at 227-15
N. Conduit Avenue, Laurelton, NY 11413 (referred to herein as "Epic" or "Manufacturer"). Mikah and Epic are
each a "Party" and together constitute the "Parties" to this agreement

 

A.     WHEREAS
Mikah desires that Epic performs certain services relating to the Product(s) (as defined below), including (a) developing and preparing
the documentation required for the transfer of the manufacturing process to Epic's facility and the filing of a CBE30 for the ANDA,
and (b) manufacturing finished dosage forms appropriate for commercial sale, marketing and distribution in the Territory (as defined
below) in accordance with the requirements of this Agreement; and

 

B.     WHEREAS
Epic desires to perform such technology transfer, manufacturing and supply services to enable Mikah or its designees to commercially
market, sell and distribute the Product(s) upon the terms and conditions of this Agreement entered into between the Parties and
incorporated herein by reference.

 

NOW, THEREFORE in consideration of the
mutual covenants and agreements contained herein, the sufficiency and satisfaction of which are hereby acknowledged, Mikah and
Epic hereby agree as follows:

 

ARTICLE 1

DEFINITIONS

 

The following capitalized terms have the
meanings set forth in this Agreement

 

"Affiliate(s)'' shall mean any person
or entity which, directly or indirectly, controls, is controlled by, or is under common control with, a party or its assignee.
Control shall be determined based upon either their legal right to control or de facto control of the entity.

 

"ANDA" means Abbreviated New
Drug Application and all amendments thereto, that have to date been filed with the FDA seeking authorization and approval to manufacture,
package, ship and sell, as more fully defined in 21 C.F.R. Part 314, the Products, as well as the Abbreviated New Drug Application
for any other Product hereafter added to the terms of this Agreement.

 

"API" means the active pharmaceutical
ingredient required for the Products.

 

"Applicable Laws" means all
laws, ordinances, codes, rules and regulations within the Territory applicable to the Manufacturing of the Product or in any
territory applicable to any aspect thereof and the obligations of Epic or Mikah, as the context requires under this
Agreement, including, without limitation: (a) all applicable federal, state and local laws and regulations of the Territory
(including Environmental Laws) relating to the Manufacture of the Products; (b) the United States Federal Food, Drug and
Cosmetic Act, and (c) the regulations promulgated under the FD&C Act including without limitation those regarding the
Good Manufacturing Practices ("cGMP") each as amended from time to time.

  

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"Confidential Information" is
as defined in Section 10.2.

 

"Data" shall refer to all data,
materials, plans, reports, test results and other information developed solely by or for Mikah in connection with the Technology
Transfer and/or the Manufacturing of the Products.

 

"Defective Product" means any
Product that fails to conform to the Specifications or Applicable Laws.

 

"Effective Date" means the date
this Agreement was fully executed.

 

"Facility" means Epic's manufacturing
facility located at 227-15 N. Conduit Avenue, Laurelton, NY 11413.

 

“FDA" means the United States
of America Food and Drug Administration.

 

"Intellectual Property" means
without limitation, patents, patent applications, knowhow, trade secrets, copyrights, trademarks, designs, concepts, technical
information, manuals, standard operating procedures, instructions or specifications.

 

"Latent Defect" means a defect:
(a) which could not reasonably have been discovered upon receipt and careful inspection of the Product and (b) for which the assignable
cause has been attributed to the actions or omissions of Epic prior to delivery of the Product.

 

"Manufacture(d)" or "Manufacturing"
means the compounding, filling, producing, testing and/or packaging of the API and Raw Materials into a finished dosage form in
accordance with the Specifications and the terms and conditions set forth in this Agreement.

 

"Mikah Technology" means any
and all data, Specifications, formulations, analytical methods, reports, studies, or other information in whatever form, relating
to the Products that are owned or controlled by Mikah as of the Effective Date and/or during the Term of this agreement.

 

"Patent Defect" shall mean any
instance where a Product, fails to conform to the Specifications or fails to conform to the indemnifications given by Epic herein,
and such failure is discoverable upon reasonable physical inspection or standard testing procedures upon receipt by Mikah or its
affiliates in accordance with applicable standard operating procedures.

 

"Product" means each of the pharmaceutical
products now or hereafter listed on Exhibit A, as it may be amended by the Parties from time to time.

 

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"Purchase Order" shall have the
meaning set forth in Section 3.4.

 

"Raw Materials" means all raw
materials (including APIs), supplies, components and packaging necessary to manufacture and ship the Product in accordance with
the Specifications.

 

"Regulatory Authority" means
any governmental regulatory authority within a Territory involved in regulating any aspect of the development, manufacture, testing,
market approval, sale, distribution, packaging or use of the Product.

 

"Rolling Forecast" shall have
the meaning set forth in Section 3.2.

 

"Specifications" means with respect
to each Product, the procedures, requirements, standards, quality control testing and other data and the scope of services as set
forth or referenced in the ANDA, the relevant portions of which shall be supplied to Epic, and are hereby incorporated by reference
into this Agreement, along with any amendments or modifications thereto, subject to the terms and conditions set forth in Article
7.

 

"Technology Transfer" shall mean
transfer of the ANDA's manufacturing process and analytical methods developed or owned by Mikah to Epic, including but not limited
to: the transfer of the formulation; range finding; the manufacture of a confirmation batch and an exhibit batch at the Facility;
methods transfers and improvements; updating USP and regulatory requirements as they relate to the methods; selection of suitable
API, excipients and specifications; the manufacturing of pivotal submission batches at the Facility and the preparation of all
documentation required for Mikah's filing and approval of a CBE30 with FDA.

"Term" shall have the meaning set forth in Article 14.1.

 

"Territory" means the United
States of America, its territories, possessions, commonwealths and any other country, which the Parties agree in writing to add
to this definition of Territory in an amendment to this Agreement.

 

ARTICLE 2

TECHNOLOGY TRANSFER, VALIDATION & RELATED
SERVICES

 

2.1           Services.
Epic shall perform, at its sole cost and expense, all Technology Transfer, validation and qualification services (including: equipment,
methods and facility qualification), validation and stability services required by Applicable Laws to commence manufacturing the
Product for commercial sale by Mikah or its designees in accordance with the terms of this Agreement.

 

2.2           Supply
of API, Excipients and Packaging Material. Epic shall provide the API, excipients, capsules bottles, labels and chemicals
needed for the manufacture of the Product pursuant to this Agreement Epic will be responsible for the testing and conforming release
of the API, excipients and packaging materials and maintaining the required storage conditions directed by the Specifications.

 

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2.3           Labeling. Mikah shall provide
Epic with all artwork copy or other material templates developed or produced by Mikah or its Affiliates for the Product labels,
printed packaging materials and Product inserts. Epic shall purchase the labels and printed materials. Epic shall not make any
changes to the artwork, copy or other materials submitted by Mikah without the prior written approval of Mikah or its Affiliates.
Epic will submit to Mikah, for Mikah's approval, a proof of all Product labels, printed packaging materials and Product inserts
prior to printing.

 

ARTICLE 3

MANUFACTURE AND SUPPLY

 

3.1           Supply
and Purchase of Product. During the Term of this Agreement and subject to the provisions herein, Mikah shall purchase from
Epic and Epic agrees to manufacture and supply solely and exclusively to Mikah, such Product as Mikah may order from time to time
pursuant to this Agreement. Mikah hereby grants to Epic a nonexclusive, royalty-free license, under which Epic has no right to
grant sublicenses, and to use Mikah Technology and the Work Product to Manufacture and supply Product solely for and to Mikah.
Epic shall manufacture the Product at its Facility in accordance with the ANDA, the Specifications. Applicable Laws, and the terms
and conditions of this Agreement. During the Term of this Agreement and subject to Mikah receiving final approval of the Product
ANDAs from FDA, Mikah shall purchase the Product, in finished packaged form, from Epic in accordance with the terms and conditions
of this Agreement. Epic shall not manufacture the Product or any derivative thereof, whether for itself or for any other company,
broker, or distributor whatsoever.

 

3.2           Forecasts.
Commencing three months before the anticipated commercial launch of each Product, Mikah or Actavis, Mikah's designee, shall
provide Epic with non-binding rolling twelve (12) month forecasts of its Product requirements by delivery date. These
forecasts will become binding only upon issuance of a Purchase Order by Mikah. The forecasts will be updated monthly during
the first business week of each calendar month ("Rolling Forecasts"). The Parties agree to discuss the forecasts
and the status of the business for the Product quarterly. The Parties further agree that all such forecasts are for planning
purposes only and Mikah shall have no obligation to purchase Product consistent with such forecasts hereunder except as may
be set forth in a Purchase Order (defined below). Epic agrees to keep at least that amount of inventory of Raw Materials on
hand or with Epic to meet Mikah's forecasted Product requirements. It is understood between the Parties that all forecast
information must be kept completely confidential.

 

3.3           Reliance
on Forecasts. Epic shall use the forecasts to order and maintain the Raw Materials necessary to fulfil the forecasted Product
requirements, taking into account the Raw Material vendor's lead times, minimum order quantities, and Epic's lead time. In no case
will Epic maintain more than a three (3) month supply of Raw Materials without Mikah's prior written consent.

 

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3.4           Purchase
Orders. Mikah or Actavis, Mikah's designee, shall submit Purchase Orders for Product ("Purchase Orders") specifying:
(a) the number of units of Product to be purchased, (b) the Price, (c) the expected delivery date, and (d) such other special terms
and conditions that may be applicable to such order. For every delivery, per Product, a firm binding order must be made at least
two (2) months in advance of delivery date or such lesser period of time that the Parties may agree to, in writing. Epic shall
confirm the order and projected date of shipment within seven (7) calendar days after having received a Purchase Order. All Purchase
Orders received and not rejected by Epic within 7 days of Epic's receipt shall be deemed to have been confirmed by Epic in accordance
with its reflected terms. Epic shall accept all Mikah Purchase Orders (whether submitted by Mikah or Actavis), as described herein.
Though Epic shall not be obligated to fulfill any order received less than two (2) months prior to a requested shipment date for
any Product, Epic shall use commercially reasonable efforts to accommodate any requested shipment date.

 

3.5           Capacity.
Epic shall, at all times during the term hereof, maintain the Manufacturing capacity to supply at least 125% of the quantities
forecasted by Mikah.

 

3.6           Terms of Sale. Mikah orders for Product shall be made pursuant to its (or Actavis's) standard form of Purchase Order. To the
extent such Purchase Order contains terms or conditions that are in conflict with the terms and conditions of this Agreement, the
conflicting terms or conditions of the Purchase Order will have no effect, unless Epic agrees, in writing, to such terms or conditions
or that such terms and conditions will supersede the terms of this Agreement.

 

3.7           Order
Cancellation or Changes. Mikah may cancel a Purchase Order or modify the date of shipment or the quantity of Product specified
in a Purchase Order, by submitting a written change order to Epic at least thirty (30) days in advance of the previously requested
date of shipment. All such change orders shall be binding and effective upon receipt by Epic. If Mikah requests a cancellation
or modification of a Purchase Order less than 30 days in advance of the previously requested delivery date, such change order shall
be binding and effective only upon the written approval by Epic. Epic shall use commercially reasonable efforts to approve the
cancellation or modification requested by Mikah, or such other modifications that might be mutually acceptable, and shall advise
Mikah of its determination within 3 business days of the submission of Mikah's proposed change order. In the case of partial acceptance,
Epic shall specify the quantities and date of shipment of the portion of the Order it can accept, and Mikah shall be entitled to
fill any additional amounts not Manufactured by Epic from a Second Source.

 

3.8           Timeliness
of Delivery. It is of essence to this Agreement that Epic delivers the Product at the date of shipment stated in the order
confirmation. If for any reason Epic believes that delivery of any Purchase Order will be delayed, Epic shall promptly advise Mikah
as well as the new anticipated delivery date. If Epic fails to deliver the full quantity of Product on or before the delivery date
specified in the applicable confirmed Purchase Order, for any reason other than Force Majeure, Epic shall compensate Mikah for
any losses or fines imposed by its direct or indirect customer, and Mikah shall have the right to find or use a second source for
the supply of the Product.

 

3.9           Shipment.
All Product shall be delivered EXW, Epic's loading dock. Upon Epic's delivery of the Product EXW, Mikah will bear all risk of loss,
delay, or damage in transit as well as all costs of further shipment and appropriate insurance. All Product delivered hereunder
shall be suitably packed for shipment by Epic in accordance with good commercial practice, and instructions provided to Epic by
Mikah, with respect to protection of such Product during transportation and marked for shipment to Mikah. Such shipment shall also
include a Certificate of Analysis ("C of A") and a Certificate of Compliance ("C of C") in accordance with
the terms of the Quality Agreement.

 

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3.10         Residual
Materials. If Mikah (i) cancels or modifies its Purchase Orders pursuant to Section 3.7, or (ii) requests that Epic purchase
any Raw Materials prior to the placement of the related Purchase Order, which creates residual inventory of the API or other Raw
Materials that Epic has purchased in accordance with the terms of this Agreement, Mikah shall purchase any APJ and other Raw Materials
that Epic purchased in accordance with Section 3.3 of this Agreement which Epic cannot return or use elsewhere, as reasonably
determined by Epic. Mikah shall purchase such API or other Raw Materials from Epic for an amount equal to Epic's actual cost therefore,
within sixty (60) days of Epic's written request and delivery of such Raw Materials, provided Epic certifies to Mikah that the
API and other Raw Materials purchased by Mikah have been stored and otherwise maintained by Epic under cGMP conditions.

 

3.11         First
Priority. Epic hereby agrees that it shall not Manufacture or process goods for itself or for a third party where to do so
will, as a consequence, delay delivery of Mikah's firm Purchase Order requirements of Product under this Agreement or cause Epic
to refuse or fail to accept a Purchase Order in the manner set forth herein.

 

3.12         Second
Source. At any time during the term of this Agreement, Mikah may seek to establish a second source for the Manufacture of any
or all of the Products. Upon notice of such intention, and in compliance with all applicable confidentiality obligations set forth
herein or elsewhere, Epic shall cooperate in any way reasonably necessary to permit such second source to be validated as a Manufacturing
site of the Product under the ANDA.

 

3.13         Facility
Transfer. In the event that Epic breaches any of its obligations or requirements under this Agreement and fails to cure any
such breach within 60 days of notice thereof by Mikah (or if earlier, on the date such breach results in the inability of Mikah
to sell and market the Products or any of them under the provisions of the FD&C Act or applicable Laws), Mikah shall have the
right to take all actions necessary to accomplish a Technology Transfer to a different manufacturing facility for the Product so
effected (a "Facility Transfer").The Facility Transfer shall be at the cost and expense of Epic. Upon and after a Facility
Transfer made pursuant to this Section, Mikah shall not be obligated to make any payments to Epic with respect to Product that
is not manufactured at Epic's Facility. Any facility Transfer shall be effective until the Product Termination Date for each individual
Product. The rights of Mikah under this Section shall be in addition to its other rights under this Agreement.

 

ARTICLE 4

PRICE AND PAYMENT

 

4.1        Supply Price and Other Payments.
Attached hereto as Exhibit B is the pricing for the Product and certain additional payments that shall be made by Mikah to Epic
in connection with this Agreement.

 

4.2        Audit Right. Mikah reserves
the right, upon advance written notice to audit Epic's documentation related to any charges submitted to Mikah. In the event that
such an audit results in a calculation, which differs, from the audited party's calculations, the Parties agree to negotiate in
good faith to reach agreement as to the amount of the Price adjustment. In the event that the Parties cannot reach agreement, the
Parties agree to hire an independent third party auditor, and share the costs of such audit, whose determination shall be binding
on both Parties.

 

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4.3        Payment Terms. All amounts payable under this Section shall be expressed in United States Dollars and shall be due and payable
by Mikah to Epic within 60 of delivery of the finished packaged lots. All payments shall be made by wire transfer in accordance
with written instructions given by Epic from time to time.

 

ARTICLE 5

PRODUCT CONFORMITY TO SPECIFICATIONS

 

5.1        Notification
of Defective Product. Mikah shall notify Epic within sixty (60) days after receiving the Product if Mikah has determined
that such shipment contains a quantitative defect such that Epic has delivered a quantity of Product that is less than the
quantity stated in any invoice or bill of landing. Epic shall, at its own cost and expense, supply Mikah with any missing
quantities of Product as soon as practical after receipt of such Notice (as defined herein). Notice of Patent Defect shall be
provided by Mikah to Epic within sixty (60) days of inspection of Product in such shipment Mikah shall provide Epic a sample
of such Defective Product Notice of a Latent Defect shall be provided within thirty (30) days after Mikah notices the Latent
Defect.

 

5.2        Resolution of Defective Product.
Notwithstanding the foregoing, Mikah shall have the right to reject any batch of Product having Latent Defects prior to the expiry
of such batch of Product. If Epic agrees that the batch is Defective Product, Epic shall, at its option, replace the Defective
Product or repay the full amount of any payments, including shipping and recall costs and cost of API, made by Mikah for such Product.
If Epic does not agree with Mikah's determination that such Product is Defective Product, then after reasonable efforts to resolve
the disagreement, either Party may submit a sample of such Product to a mutually agreed upon independent third party who is an
expert or is familiar with the industry to determine whether the Product meets the Specifications. The independent party's results
shall be final and binding and if such results indicate that the Product was a Defective Product, Epic shall, at its option, replace
the Defective Product or repay the full amount of any payments, including shipping costs and cost of API, made by Mikah for such
Product. Unless otherwise agreed to by the Parties in writing. the costs associated with such testing and review shall be borne
by the non-prevailing Party.

 

ARTICLE 6

DELIVERY

 

6.1           Delivery.
Epic shall segregate and store all Product until its shipment on the dates reasonably meeting the delivery dates specified by Epic's
commitments issued in connection with Mikah's Purchase Orders. Epic shall tender the Product for delivery to the destination specified
by Mikah. Mikah shall be responsible for all costs associated with the Product after delivery by Epic to the specified destination
in accordance with the terms of this Agreement.

 

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6.2           Shelf
Life. All Product shipped to Mikah shall have at least twenty-one (21) months of saleable shelf life remaining upon receipt
of Product at destination in accordance with Section 6.1 except for the exhibit and validation lots.

 

ARTICLE 7

CHANGES TO SPECIFICATIONS

 

All Specifications and any changes thereto
agreed to by the Parties from time to time shall be in writing, dated and signed by the Parties. No change in the Specifications
shall be implemented by Epic without the prior written approval of Mikah. Epic shall respond promptly to any request made by FDA
or Mikah for a change in the Specifications or the Facility, and both Parties shall use commercially reasonable, good faith efforts
to agree to the terms of any requested change in the Specifications or the Facility that affects the Manufacture of the Product
in a timely manner.

 

ARTICLE 8

RECORDS AND REGULATORY MATTERS

 

8.1           Batch
Records and Data. Within a reasonable period of time following the completion of Manufacturing of the first batch of each Product,
and on the anniversary of the signing of this Agreement thereafter, Epic shall provide Mikah with properly completed copies of
batch records prepared in accordance with the Specifications; provided, however, that if testing reveals an out-of-Specification
result, Epic shall provide such batch records within 14 days following resolution of the out-of-Specification result. In addition,
for all shipments of Product, Epic shall provide Mikah with an accurate COA and Mikah shall accept such COA given in good faith,
regardless of whether or not Mikah shall accept the Product.

 

8.2           Recordkeeping.
Epic shall maintain true and accurate books, records, test and laboratory data, reports and all other information relating to Manufacturing
under this Agreement, including all information required to be maintained by all Applicable Laws. Such information shall be maintained
in original forms, notebooks and records for a period of at least three (3) years from the relevant finished Product expiration
date or longer if required under Applicable Laws.

 

8.3           Regulatory
Compliance. Epic shall act as Mikah's regulatory agent and shall be responsible for the correspondence with the Regulatory
Authority with respect to the Product and the Specifications, including any product licenses, applications and amendments in connection
therewith. Epic will be responsible to maintain all permits and licenses required by any Regulatory Authority with respect to the
Facility and its equipment and the manufacture and distribution of the Product Each Party intends and commits to cooperate to satisfy
all Applicable Laws within the scope of its respective responsibilities under this Agreement.

 

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8.4           Regulatory
Correspondence. Mikah shall be the sole owner of the ANDA. Epic shall notify Mikah immediately of any correspondence, any inspections,
and the result of any inspection(s) with the FDA or any Regulatory Authority. Epic shall immediately send a draft to Mikah of all
correspondence Epic intends to send to any Regulatory Authority, related to the Product For all correspondence with a Regulatory
Authority, related to the Product that is not in response to a regulatory deficiency or problem, Mikah shall have fourteen (14)
business days to approve the draft correspondence, and if Mikah is silent after fourteen (14) business days, it is understood Mikah
gives its constructive consent to the correspondence. For all correspondence with a Regulatory Authority, related to the Product
that is in response to a regulatory deficiency or problem, Mikah shall have the absolute right to approve the draft correspondence
before such correspondence is sent to the Regulatory Authorities. In such a case, Mikah will make every effort to act expediently
in approving the draft correspondence.

 

8.5           Governmental
Inspections and Requests. Epic shall immediately advise Mikah if an authorized agent of any Regulatory Authority visits the
Facility or any portion thereof, which may affect the Manufacturing of the Product. Epic shall furnish to Mikah a copy of the report
by such Regulatory Authority, if any, within ten (10) days of Epic's receipt of such report. Further, upon receipt of a Regulatory
Authority request to inspect the Facility or audit Epic's books and records and such inspection would affect the Manufacturing
under this Agreement, Epic shall immediately notify Mikah, and shall provide Mikah with a copy of any written document received
from such Regulatory Authority.

 

8.6           Recall.
In the event Epic believes a recall, field alert, Product withdrawal or field correction may be necessary with respect to any Product
provided under this Agreement, Epic shall immediately notify Mikah in writing (for the sake of clarification "immediately"
as used in this section shall mean no more than two (2) days). Epic will not act to initiate a recall, field alert, Product withdrawal
or field correction without the express prior written approval of Mikah, unless otherwise required by Applicable Laws. In the event
Mikah believes a recall, field alert, Product withdrawal or field correction may be necessary with respect to any Product provided
under this Agreement, Mikah shall immediately notify Epic in writing and Epic shall provide all necessary cooperation and assistance
to Mikah. The cost of any recall, field alert, Product withdrawal or field correction shall be borne by Mikah except that Epic
shall be obligated to reimburse Mikah for recall, field alert, Product withdrawal or field correction costs incurred by Mikah to
the extent such recall, field alert, Product withdrawal or field correction is caused by Epic's breach of its representations,
warranties, or obligations under this Agreement, Applicable Laws or its negligence or willful misconduct. For purposes hereof,
recall costs shall be limited to reasonable, actual and documented administrative costs incurred by Mikah or third party customers
directly in connection with such recall, withdrawal or correction, replacement and disposal of the Defective Product to be recalled,
in accordance with Article 5.

 

8.7           Inspections
and Audits by Mikah. Representatives of Mikah shall have access to the Facility for the purpose of: (a) conducting inspections
of such facility and Epic's maintenance and usage of the equipment utilized in the development and manufacture of Product, (b)
performing quality control audits or (c) witnessing the development, manufacturing, storage or transportation of the Product or
the materials related to or used in the manufacture of Product including API. Mikah shall have access to the results of any tests
performed by Epic relating to Product and the API or the processes or materials used in the development and manufacture. Epic shall
use its best efforts to ensure that Mikah has similar access to the facilities, data and records of Epic's Epics or agents. Such
inspections do not relieve Epic of any of its obligations under this Agreement or create new obligations on the part of Mikah.
Such visits by Mikah's representatives shall be conducted during normal business hours.

 

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ARTICLE 9

REPRESENTATIONS
AND WARRANTIES

 

9.1           Epic.
Epic hereby represents, warrants and covenants to Mikah that:

 

9.1.1           At the time of each delivery of the Product as provided under this Agreement, such Product and its corresponding Raw Materials
will conform to and will have been manufactured, stored and transported in full conformance with the Specifications, cGMPs and
all Applicable Laws;

 

9.1.2           The
Product shall not, at the time of delivery to Mikah, contain any material or be manufactured, handled or stored in any way that
would cause the Product to be adulterated in any way within the meaning of Section 501 or misbranded within the meaning of Section
502 of the Food, Drug and Cosmetic Act, as amended;

 

9.1.3           As of the Effective
Date and at all times during the Term, Epic and the Facility and all equipment utilized in the manufacture of the Product is and
will be in compliance with all Applicable Laws, including all applicable workplace safety regulations under OSHA (or the equivalent
local governmental entity), all tax regulations and Environmental Laws;

 

9.1.4           At
all times during the Term, Epic shall obtain Mikah's written approval for the use of any third party contract laboratory intended
for the testing and release of API, excipients and/or finished Product if such laboratory is not filed in said ANDA.

 

9.1.5           At
all times during the Term, Epic shall continue to hold all licenses, approvals, permits and similar authorizations of Regulatory
Authorities necessary or required to operate the Facility and its equipment;

 

9.1.6           Neither
Epic nor any of its employees has ever been: (a) debarred. or (b) convicted of a crime for which a person can be disbarred
under Section 306 (a) or (b) of the Generic Drug Enforcement Act of 1992 as amended from time to time, or (c) been convicted
of any crime in the country where the Product is manufactured. Epic agrees to immediately notify Mikah should any Regulatory
Authority threaten any action that could possibly result in a breach of this Section;

 

9.1.7           The
Manufacture, storage, packaging and labeling of the Product shall be in complete accordance with all Applicable Laws, the ANDA
and the Specifications and will be made, stored. packaged, labeled and controlled by Epic in accordance with any other applicable
manufacturing information, or regulatory requirements;

 

9.1.8           Unless
otherwise agreed by the Parties in writing. Epic has: (a) reviewed and approved all Specifications, (b) if applicable, reviewed
and approved all in-process and finished Product test results to ensure conformity of such results with the Specifications, regardless
of which Party is responsible for finished Product release;

 

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9.1.9           The
COA which will accompany each shipment of Product shall be accurate, truthful and made in good faith such that Mikah shall be able
to legally rely on each COA;

 

9.1.10         During the Term of this
Agreement, and subject to the provisions herein, including but not limited to Section 3.2, Epic shall not develop, manufacture,
market or sell any product competitive with the Product, nor shall it offer any assistance, or permit any of its employees to offer
any assistance to any third party (including for this purpose any Affiliate of Epic in the world) to take any action which Epic
would be prohibited from engaging in pursuant to this Article;

 

9.1.11         Neither
Epic nor any of its Affiliates is manufacturing the Product or any derivative thereof for any other person, entity or company whatsoever.
Following the execution of this Agreement, neither Epic nor any of its Affiliates shall develop or manufacture the Products with
or for any third party.

 

9.1.12         Neither
Epic nor any of its Affiliates shall manufacture, market or distribute any of the Products. whether for their own benefit or for
the benefit of a third party, for a period of five years following the termination of this Agreement.

 

9.2           Mikah.
Mikah hereby represents, warrants and covenants to Epic that:

 

9.2.1           All
artwork templates and the content thereof provided to Epic shall comply with all Applicable Laws;

 

9.2.2           All
Product delivered to Mikah by Epic will be held, used and/or disposed of by Mikah in accordance with all Applicable Laws; and

 

9.2.3           Mikah
will comply with all Applicable Laws applicable to Mikah's performance under this Agreement and its use of any materials or Product
provided by Epic under this Agreement; and

 

9.3           Mutual.
Each Party hereby represents, warrants and covenants to the other Party that:

 

9.3.1           Existence
and Power. Such Party: (a) is duly organized, validly existing and in good standing under the laws of the state in which it is
organized, (b) has the power and authority and the legal right to own and operate its property and assets, and to carry on its
business as it is now being conducted, and (c) is in compliance with all requirements of Applicable Laws.

 

9.3.2           Authorization
and Enforcement of Obligations. Each Party: (a) bas the power and authority and the legal right to enter into this Agreement
and to perform its obligations hereunder and (b) has taken all necessary action on its part to authorize the execution and
delivery of this Agreement and the performance of its obligations hereunder;

 

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9.3.3           Execution and Delivery.
This Agreement has been duly executed and delivered on behalf of each Party, and constitutes a legal, valid, binding obligation,
enforceable against such Party in accordance with its terms;

 

9.3.4           No
Consents. All necessary consents, approvals and authorizations of all Regulatory Authorities and other persons required to be obtained
by such Party in connection with the Agreement have been obtained; and

 

9.3.5           No
Conflict. The execution and delivery of this Agreement and the performance of such Party's obligations hereunder: {a) do not conflict
with or violate any requirement of Applicable Laws; and (b) do not materially conflict with, or constitute a material default or
require any consent under any current contractual obligation of such Party.

 

9.4           Survival.
The obligations of this Article 9 will terminate five (5) years from the expiration or termination of this Agreement.

 

9.5           Limitations.
THE REPRESENTATIONS AND WARRANTIES SET FORTH IN THIS ARTICLE ARE THE SOLE AND EXCLUSIVE REPRESENTATIONS AND WARRANTIES MADE BY
EACH PARTY TO THE OTHER AND NEITHER PARTY MAKES ANY OTHER REPRESENTATIONS. WARRANTIES OR GUARANTEES OF ANY KIND WHATSOEVER INCLUDING
WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.

 

ARTICLE 10

CONFIDENTIAL INFORMATION

 

10.1         Mutual
Obligation. Epic and Mikah agree that they will not disclose the other Party's Confidential Information (defined below) to
any third party without the prior written consent of the other Party except as required by law, regulation or court or administrative
order; provided. However, that prior to making any such legally required disclosure, the Party making such disclosure shall give
the other Party as much prior notice of the requirement for and contents of such disclosure as is practicable under the circumstances.
Notwithstanding the foregoing, each Party may disclose the other Party's Confidential Information to any of its Affiliates that:
(a) need to know such Confidential Information for the purpose of performing under this Agreement (b) are advised of the contents
of this Article, and (c) agree to be bound by the terms of this Article.

 

10.2         Definition.
As used in this Agreement, the term "Confidential Information" includes all such information rotated to the Product furnished
by Epic or Mikah, or any of their respective representatives or Affiliates.to the other or its representatives or Affiliates, whether
furnished before, on, or, after the date of this Agreement and furnished in any form, including but not limited to written. Verbal,
visual, electronic or in any other media or manner. Confidential Information includes all proprietary technologies, Intellectual
Property, analyses, compilations, business or technical information and other materials prepared by either Party, or any of their
respective representatives, containing or based in whole or in part on any such information furnished by the other Party or its
representatives. Confidential Information also includes the existence of this Agreement and its terms as well as the Confidentiality
Agreement signed as of March __, 2011 which is hereby made a part of this Agreement and is attached hereto as Exhibit D.

 

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10.3         Exclusions.
Notwithstanding Section 10.2. Confidential Information does not include information that: (a) is or becomes generally available
to the public or within the industry to which such information rotates other than as a result of a breach of this Agreement. or
(b) is already known by the receiving Party at the time of disclosure as evidenced by the receiving Party's written records, or
(c) becomes available to the receiving Party on a non-confidential basis from a source that is entitled to disclose it on a non-confidential
basis, or (d) was or is independently developed or discovered by or for the receiving Party without reference to the Confidential
Information, as evidenced by the receiving Party’s written records.

 

10.4         Return
of Confidential Information. Upon termination of this Agreement, the receiving Party shall, upon request, promptly return within
thirty (30) days all such Confidential Information, including any copies thereof, and cease its use or, at the request of the disclosing
Party, shall promptly destroy the same and certify such destruction to the disclosing Party; except for a single copy thereof,
which may be retained for the sole purpose of complying with the scope of the obligations incurred under this Agreement.

 

10.5         Survival.
The obligations of this Article 10 will terminate five (5) years from the expiration of this Agreement.

 

ARTICLE 11

INTELLECTUAL PROPERTY

 

11.1         Notice
of Infringement Claim. In the event that a third party at any time provides written notice of a claim to, or brings an action,
suit or proceeding against, any Party, any of their respective Affiliates, in each case claiming infringement of third party patent
rights based upon an assertion or claim arising out of the filing of an ANDA for the Product, or development, manufacture, marketing,
distribution, sale, import or use of the Products in the Territory by Mikah ("Infringement Claim"), such Party shall
promptly notify the other Party of the claim or the commencement of such action, suit or proceeding, enclosing a copy of the claim
and all papers served.

 

11.2         Exclusive
Right to Defend. Mikah shall have the sole and exclusive right, but not the obligation, to defend and/or settle any such Infringement
Claim. If an Infringement Claim is brought against Epic ("Epic Infringement Claim"), then Epic shall so notify Mikah
in writing within fifteen (15) days of receipt. Upon proper notification of the Epic Infringement Claim,

 

(i)            Mikah
shall have the sole and exclusive right to select counsel for such claim and final decision making authority regarding all aspects
of the defense and settlement of such claim,

 

(ii)           Epic
shall be entitled to participate in the defense of an Epic Infringement Claim and to employ counsel at its expense to assist therein,
and

 

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(iii)          Epic
shall provide Mikah with such information and assistance as Mikah may reasonably request.

 

11.3         Epic
Assistance. Upon written request from Mikah, Epic shall promptly provide Mikah and/or its counsel with such access to information
about, and personnel knowledgeable of, the Products and their formulation, use and process of manufacture to enable Mikah to:

 

(i)           ascertain
whether the manufacture, marketing, distribution, sale, import or use of the Products in and for the Territory will infringe any
existing patent of a third party;

 

(ii)          determine
its conduct in relation to any proceedings alleging infringement of a third party's patent in the Territory;

 

(iii)         provide
witnesses or documentation from Epic in any proceedings alleging infringement of a third party's patent in the Territory; and

 

(iv)         if
deemed advisable, the Parties shall enter into a joint defense agreement containing customary terms and conditions for the purpose
of, inter alia, preserving confidentiality and any applicable privilege attaching to information and data exchanged by the parties
under and pursuant to this Agreement

 

ARTICLE 12

INDEMNIFICATION

 

12.1         Indemnification
by Epic. Epic shall defend, indemnify and hold harmless Mikah, and its directors. officers, employees and agents ("Mikah
Indemnitees") from and against any and all suits, claims, losses, demands, liabilities, damages, costs and expenses (including
reasonable attorneys' fees) in connection with any suit, demand or action by any third party ("Losses") arising out of
or resulting from: (a) any breach of its representations, warranties or obligations set forth in this Agreement or resulting from
the breach of its obligations to deliver Product in full conformity to the Specifications, or for Product to remain in full conformity
through its expiration date and in conformity with all Applicable Laws or (b) any negligence or willful misconduct by Epic, except
to the extent that any of the foregoing arises out of or results from any Mikah Indemnitee’s obligations set forth in Section
12.2 below.

 

12.2         Indemnification
by Mikah. Mikah shall defend, indemnify and hold harmless Epic, its Affiliates, and their respective directors, officers, employees
and agents ("Epic Indemnitees") from and against all Losses arising out of or resulting from: (a) any breach of its representations,
warranties or obligations set forth in this Agreement; or (b) any negligence or willful misconduct by Mikah, except to the extent
that any of the foregoing arises out of or results from any Epic Indemnitee's obligations set forth in Section 12.1 above.

 

12.3         Indemnification
Procedures. All indemnification obligations in this Agreement are conditioned upon the Party seeking indemnification: (a) promptly
notifying the indemnifying Party of any claim or liability of which the Party seeking indemnification becomes aware (including
a copy of any related complaint, summons, notice or other instrument); provided, however, that failure to provide such notice within
a reasonable period of time shall not relieve the indemnifying Party of any of its obligations hereunder except to the extent the
indemnifying Party is prejudiced by such failure; (b) cooperating with the indemnifying Party in the defense of any such claim
or liability; and (c) not compromising or settling any claim or liability without prior written consent of the indemnifying Party.

 

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ARTICLE 13

INSURANCE

 

13.1         Epic
Insurance. Epic shall, at its own cost and expense. obtain and maintain in full force and effect the following insurance
during the term of this Agreement: (i) Commercial General Liability insurance with per-occurrence and general aggregate
limits of not less than $1,000,000; (ii) Products and Completed Operations Liability Insurance with per-occurrence and
general aggregate limits of not less than $5,000,000; (iii) Statutory Workers' Compensation and Employer's Liability
Insurance with an amount not less than $500,000 including excess liability coverage. In the event that any of the required
policies of insurance arc written on a claims made basis, then such policies shall be maintained during the entire term of
this Agreement and for a period of not less than three (3) years following the termination or expiration of this Agreement
Epic shall waive subrogation rights against Mikah for workers' compensation benefits and shall obtain a waiver from any
insurance carriers with which Epic carries workers' compensation insurance releasing their subrogation rights against Mikah.
Mikah shall be named as an additional insured under the Commercial General Liability and Products and Completed Operations
Liability insurance policies as respects the manufacturing services outlined in this Agreement. Epic shall furnish
certificates of insurance for all of the above noted policies and required additional insured status to Mikah within 10 days
after the Effective Date of the Agreement and upon renewal of any such policies.

 

13.2         Mikah
Insurance. Mikah or its affiliate shall, at its own cost and expense, obtain and maintain in full force and effect the following
insurance during the term of this Agreement: (i) Products and Completed Operations Liability Insurance with per-occurrence and
general aggregate limits of not less than $5,000,000; (ii) Statutory Workers' Compensation and Employer's Liability Insurance with
an amount not less than $500,000 including excess liability coverage. In the event that any of the required policies of insurance
are written on claims made basis, then such policies shall be maintained during the entire term of this Agreement and for a period
of not less than three (3) years following the termination or expiration of this Agreement. Mikah shall waive subrogation rights
against Epic for workers' compensation benefits and shall obtain a waiver from any insurance carriers with which Mikah carries
workers' compensation insurance releasing their subrogation rights against Epic. Epic shall be named as an additional insured under
the Products and Completed Operations Liability insurance policies as respects the Product and completed operations outlined in
this Agreement. Mikah shall furnish certificates of insurance for all of the above noted policies and required additional insured
status to Epic within 10 days after the Effective Date of the Agreement and upon renewal of any such policies.

 

ARTICLE 14

TERM AND TERMINATION

 

14.1         Term.
This Agreement shall commence on the Effective Date and shall continue for a period of five (5) years after commercial launch of
Product, on a Product-by-Product basis, unless earlier terminated under this section (the "Term"). The Term shall automatically
renew for additional periods of one (1) year each ("Renewal Term") unless Mikah provides written notice of termination
to Epic at least six (6) months prior to the expiration of the Term or any Renewal Tenn. Epic agrees to continue to supply Product
to Mikah under the terms of this Agreement until Mikah has satisfactorily qualified a Second Source of Product.

 

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14.2         Termination
by Either Party.

 

14.2.l           Material Breach.
Either Party may terminate this Agreement effective upon sixty (60) days prior written notice to the other Party, if the other
Party commits a material breach of this Agreement and fails to cure such breach by the end of such sixty (60) day period;

 

14.2.2           Bankruptcy. Either
Party may terminate this Agreement effective upon written notice to the other Party, if the other Party becomes insolvent or admits
in writing its inability to pay its debts as they become due, files a petition for bankruptcy, makes an assignment for the benefit
of its creditors or has a receiver, trustee or other court officer appointed for its properties or assets, and shall comply with
Section 2 herein.

 

14.3         Termination
by Mikah.

 

14.3.1           Mikah
shall have the right on sixty (60) days' written notice to terminate this Agreement, or a single Product under this
Agreement, without penalty, in the event: (a) in Mikah's sole opinion, the sale of Product manufactured pursuant to this
Agreement become commercially non-viable, (b) if, in Mikah's sole opinion, any Intellectual Property rights of any third
party may be infringed, misappropriated, or otherwise violated by the manufacture, use, importation, sale or distribution of
the Product in the Territory or if there is an unacceptable risk from a product liability perspective, (c) if Mikah acquires
or merges with a company which render the Product no longer viable, (d) any Regulatory Authority requires Mikah to cease
production of Product, or (e) Mikah decides to manufacture the Product hereunder in any of its own manufacturing
facilities.

 

14.3.2           In
the event of a termination pursuant to Section 14.3.1 above, other than for intellectual property or safety reasons, the Parties
shall coordinate to sell off all in process inventory (and/or Safety Stock) that may remain in Epic's Facility upon receipt of
the Notice. In order that Epic get the benefit of absorption and Mikah have the ability to retain its customer base until such
post-notification inventory is processed and Safety Stock sold, the post notification inventory shall be manufactured into finished
dosage Product by Epic as well as the Safety Stock sold to Mikah at cost or the Parties can split the costs of the components which
were purchased by Epic to fill a Purchase Order at the time of termination or to manufacture the Safety Stock.

 

14.3.3           In
the event of a termination under Section 14.3.1(e), Epic shall provide Mikah all reasonable assistance in transferring the Product(s)
to Mikah's manufacturing facility(ies).

 

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14.4         Force
Majeure. Except as to payments required under this Agreement, if any default or delay occurs which prevents or materially impairs
a Party's performance and is due to a cause beyond the Party's reasonable contra and provided that the default or delay is not
caused by or the fault of such Party, including but not limited to an act of God, flood, fire, explosion, earthquake, casualty,
accident, terrorism, war, revolution, civil commotion, blockade, terrorism or embargo, injunction, law, proclamation, order, regulation
or governmental demand, the affected Party shall promptly notify the other Party in writing of such cause and shall exercise diligent
efforts to resume performance under this Agreement as soon as possible. Neither Party will be liable to the other Party for any
loss or damage due to such cause; nor will the Term be extended thereby. Neither Party may terminate this Agreement because of
such default or delay except upon thirty (30) days’ prior written notice to the other Party if the default or delay has existed
for five (5) months and is continuing at the end of the thirty (30) day notice period.

 

14.5         Effect
of Termination. Expiration or termination of this Agreement shall be without prejudice to any rights or obligations that
accrued to the benefit of either Party prior to such expiration or termination. In the event that this Agreement is
terminated by either Party, Epic shall assist Mikah in effecting a smooth transition to an alternate contractor of the
Product at Mikah's sole cost and expense. The rights and obligations of the Parties shall continue under Articles 4, 6, 8, 9,
10, 11, 12, 13, 14, 15, and 16 notwithstanding expiration or termination of this Agreement.

 

ARTICLE 15

LIMITATIONS OF LIABILITY

 

NEITHER PARTY SHALL BE LIABLE TO THE OTHER
PARTY FOR INDIRECT, INCIDENTAL, SPECIAL OR CONSEQUENTIAL (EXCEPT FOR TIIOSE INDEMNITY OBLIGATIONS UNDER ARTICLE 12 THAT ARE DEFINED
AS CONSEQUENTIAL DAMAGES) DAMAGES ARISING OUT OF PERFORMANCE UNDER THIS AGREEMENT, INCLUDING WITHOUT LIMITATION, LOSS OF REVENUES,
PROFITSOR DAT WHETHER IN CONTRACT OR TORT, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

 

ARTICLE 16

NOTICE

 

All notices and other communications hereunder
("Notice(s)") shall be in writing and shall be deemed given: (a) when delivered personally; (b) when delivered by facsimile
transmission (receipt verified); (c) when received or refused, if mailed by registered or certified mail (return receipt requested),postage
prepaid; or (d) when delivered if sent by reliable express courier service with a confirmation, to the Parties at the following
addresses (or at such other address for a Party as shall be specified by like notice; provided, that notices of a change of address
shall be effective only upon receipt thereof):

 

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	To Mikah:	Mikah Pharma LLC
	 	 	 
	 	 	 
	 	 
	 	Attn: Nasrat Hakim, President
	 	Email:   nasrathakim@mikahpharma.com
	 	 
	To Epic:	Epic Pharma LLC
	 	227-15N. Conduit Avenue Laurelton, NY 114l3
	 	Attn: Jai Narine, President and Ashok Nigalaye, CEO
	 	Email:  J.Narine@epic-pharma.com
	 	Email:   A.Nigalaye@epic-pharma.com

 

ARTICLE 17

MISCELLANEOUS

 

17.1           Entire Agreement Amendments.
This Agreement, the exhibits, attachments, and any amendments hereto or thereto, including the Quality Agreement and the Confidentiality
Agreement, constitute the entire understanding between the Parties with respect to the specific subject matter hereof. No term
of this Agreement may be amended except upon written agreement of both Parties, unless otherwise provided in this Agreement.

 

17.2           Recitals.
The recitals are hereby incorporated by reference and made part of this Agreement.

 

17.3           Captions. The captions
in this Agreement are for convenience only and are not to be interpreted or construed as a substantive part of this Agreement.
The terms "Article" and "Section" shall be used interchangeably.

 

17.4           Further Assurances. The Parties
agree to execute, acknowledge and deliver such further instruments and to take all such other incidental acts as may be reasonably
necessary or appropriate to carry out the purpose and intent of this Agreement.

 

17.5           No Waiver. Failure by either
Party to insist upon strict compliance with any term of this Agreement in any one or more instances will not be deemed a waiver
of its rights to insist upon such strict compliance with respect to any subsequent failure.

 

17.6           Severability.
If any term of this Agreement is declared invalid or unenforceable by a court or other body of competent jurisdiction, the remaining
terms of this Agreement will continue in full force and effect.

 

17.7           Independent
Contractors. The relationship of the Parties is that of independent contractors, and neither Party will incur any debts or
make any commitments for the other Party except to the extent expressly provided in this Agreement. Nothing in this Agreement
is intended to create or wilt be construed as creating between the Parties the relationship of joint ventures, co-partners, employer/employee
or principal and agent.

 

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17.8         Successors
and Assigns. This Agreement will be binding upon and inure to the benefit of the Parties, their successors and permitted assigns.
Neither Party may assign this Agreement, in whole or in part, without the prior written consent of the other Party, except that
either Party may, without the other Party's consent, assign this Agreement to an Affiliate or to a successor to substantially all
of the business or assets of the assigning company.

 

17.9         Governing
Law. This Agreement shall be governed by and construed under the laws of the State of Delaware, United States of America,
excluding its conflicts of law provisions.

 

17.10       Alternative
Dispute Resolution. If any dispute arises between the Parties (“Dispute”), such Dispute shall be presented to
the respective presidents or senior executives of the Parties for their consideration and resolution. Each Party shall endeavor
to amicably resolve the dispute in good faith as a first step, prior to taking any other action.

 

17.11         Prevailing
Party. In any dispute resolution proceeding between the Parties in connection with this Agreement, the prevailing Party will
be entitled to its reasonable attorney's fees and costs in such proceeding.

 

17.12         Counterparts.
This Agreement may be executed in one or more counterparts, each of which will be deemed an original but all of which together
will constitute one and the same instrument. Any photocopy, facsimile or electronic reproduction of the executed Agreement shall
constitute an original.

 

17.13         Publicity.
Neither Party will make any press release or other public disclosure regarding this Agreement or the transactions contemplated
hereby without the other Party's express prior written consent, except as required under applicable law or by any governmental
agency, in which case the Party required to make the press release or public disclosure shall use commercially reasonable efforts
to obtain the approval of the other Party as to the form, nature and extent of the press release or public disclosure prior to
issuing the press release or making the public disclosure.

 

17.14         Conflicting
Terms. To the extent this Agreement and the ANDA Development Agreement have directly conflicting terms, this Agreement shall
govern.

 

17.15         Currency.
Wherever a currency is indicated throughout this Agreement, that currency shall be United States Dollars, unless otherwise clearly
indicated.

 

17.16         Days. Wherever reference is
made to days, working days or any measurement of time in days, calendar days shall be used regardless of weekends and holidays.

 

17.17         Sophisticated Parties. Each
Party to this Agreement is a sophisticated business party negotiating in good faith with the advice of legal counsel. Each Party
is hereby advised to seek the advice of legal counsel prior to executing this Agreement.

 

17.16         English
Language. This Agreement has been negotiated and is written in the English language, and while some of the Parties may not
speak English as their first language, they have sought the use of translators, if necessary and understand the meaning of this
entire Agreement.

 

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IN WITNESS WHEREOF, the Parties have caused
their duly authorized representative to execute this Agreement effective as of the Effective Date.

 

	MIKAH PHARMA LLC	EPIC PHARMA LLC
	 	 
	/s/ Nasrat Hakim	/s/ Ashok G. Nigalaye
	Name: Nasrat Hakim	Name: Ashok Nigalaye
	Title: President & CEO	Title: CEO
	 	 
	 	/s/ Jeenarine Narine
	 	Name: Jai Narine
	 	Title: President

 

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EXHIBIT A

PRODUCTS

 

ANDA 77-361 (Trimipramine Maleate Capsules,
25mg, 50mg and l00mg) and all amendments thereto

 

	Trimipramine Maleate Capsules,

25mg, 50mg and 100 mg	Bottle of

30's	Bottle of

90's	Bottle of

100's	Bottle of

500’s

 

(Specifications)

As set forth by each product's ANDA, United
States Pharmacopeia, applicable GMP and FDA.

 

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June 30, 2015

 

Ashok Nigalye, PhD CEO

Epic Pharma LLC

227-15 North Conduit Avenue Laurelton, NY 11413

 

		Re:	Amendment to Epic-Mikah Manufacturing and Supply Agreement
dated May 11, 2011 ("Amendment")

 

Dr. Nigalye,

 

Epic Pharma LLC, a Delaware limited liability
company ("Epic"), and Mikah Pharma LLC, Inc., a Delaware corporation Manufacturing and Supply Agreement effective as
of May 11, 20 (the "Agreement"). All capitalized terms used without definition in this letter agreement have the respective
meanings provided in the Agreement.

 

Effective as of the date of this letter
agreement, the parties agree that Exhibit B of the Agreement shall be deleted and replaced in its entirety with a new Exhibit B
that shall read as follows:

 

EXHIBIT B

SUPPLY PRICE AND OTHER PAYMENTS

 

Pricing: Epic shall manufacture Trimipramine Capsules in 30
count bottles for Mikah, in finished packaged form for the following Transfer Price:

 

	25 mg	${***}
	50 mg	${***}
	100 mg	${***}

 

Calculations of cost per 30 count bottle: The transfer
price for the 25 mg and 100 mg is ${***} per bottle excluding API cost. The price for the 50 mg 30 count bottle is
${***} excluding API cost.

 

The API cost for a 30 count bottle of
25, 50 and 100 mg of Trimipramine is ${***}, ${***} and ${***} respectively. It is calculated as follows:

 

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	1)	25mg/tablet*30 tablets/bottle * {***}
	2)	50mg/tablet*30 tablets/bottle  * {***}
	3)	100mg/tablet*30 tablets/bottle * {***}

 

Duration: The Transfer Price is fixed for
three years beginning on the effective date of the Amendment. However, price adjustments may occur, (i) upon mutual agreement of
the Parties or (ii) in the event there are special increases or decreases in the cost of Raw Materials that impact the total cost
of goods for that SKU by more than 10%.

 

Batch size: Epic may increase the 25 mg and 100 mg batch size
from {***} to {***} Capsules; and the 50 mg batch size from {***} to {***} Capsules.

 

	MIKAH PHARMA LLC	 
	 	 	 
	By:	/s/ Nasrat Haim	 
	Name:	Nasrat Hakim	 
	Title:	President and CEO	 

 

Accepted and agreed as of this June 30, 2015

 

	EPIC PHARMA LLC	 
	 	 	 
	By:	/s/ Ashok Nigalye	 
	Name:	Ashok Nigalye, PhD	 
	Title:	CEO	 

 

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Exhibit 10.1

HC2 HOLDINGS, INC.
AMENDED AND RESTATED
2014 OMNIBUS EQUITY AWARD PLAN
RESTRICTED STOCK UNIT AWARD AGREEMENT

THIS RESTRICTED STOCK UNIT AWARD AGREEMENT (the “Agreement”), is made, effective as of [DATE] (hereinafter the “Date of Grant”), between HC2 Holdings, Inc. (the “Company”), and [NAME] (the “Participant”).
RECITALS:
WHEREAS, the Company has adopted the HC2 Holdings, Inc. Amended and Restated 2014 Omnibus Equity Award Plan (as amended from time to time, the “Plan”), pursuant to which awards of Restricted Stock Units may be granted; and
WHEREAS, the Board of Directors of the Company has determined that it is in the best interests of the Company and its stockholders to grant to the Participant an award of Restricted Stock Units as provided herein and subject to the terms set forth herein.
NOW THEREFORE, for and in consideration of the premises and the covenants of the parties contained in this Agreement, and for other good and valuable consideration, the receipt of which is hereby acknowledged, the parties hereto, for themselves, their successors and assigns, hereby agree as follows:
		
	1.
	Grant of Restricted Stock Units. The Company hereby grants on the Date of Grant to the Participant a total of [insert number] restricted stock units (the “RSUs”), on the terms and conditions set forth in this Agreement and as otherwise provided in the Plan. The RSUs shall vest and be settled in accordance with Section 3 hereof.

		
	2.
	Incorporation by Reference, Etc. The provisions of the Plan are hereby incorporated herein by reference. Except as otherwise expressly set forth herein, this Agreement shall be construed in accordance with the provisions of the Plan and any capitalized terms not otherwise defined in this Agreement shall have the definitions set forth in the Plan. In the event of a conflict between the Plan and this Agreement, the terms and conditions of the Plan shall govern. The Committee shall have final authority to interpret and construe the Plan and this Agreement and to make any and all determinations under them, and its decision shall be binding and conclusive upon the Participant and his legal representative in respect of any questions arising under the Plan or this Agreement.

		
	3.
	Terms and Conditions.

		
	(a)
	Vesting and Forfeiture.  Except as otherwise provided in the Plan and this Agreement (or as otherwise provided in an employment, consulting or other 

written agreement between the Participant and the Company or any of its Subsidiaries), the RSUs shall vest as follows: [__] of the RSUs shall vest on [DATE], [___] of the RSUs shall vest on [DATE], and [__] of the RSUs shall vest on [DATE] (each such date, a “Vesting Date”), contingent upon the Participant’s continued service with the Company on each applicable Vesting Date.
		
	(b)
	Transfer Restrictions; Holding Requirement. No RSUs granted hereunder may be sold, pledged, loaned, gifted or otherwise transferred (other than by will or the laws of descent and distribution) and may not be subject to lien, garnishment, attachment or other legal process.  In addition, the Participant agrees to comply with any written holding requirement policy adopted by the Company for employees in respect of any shares of Common Stock delivered in connection with the settlement of the RSUs. 

		
	(c)
	Settlement. As soon as reasonably practicable following the Vesting Date (as applicable, but in any event, within 5 days following such Vesting Date), any RSUs that become vested and non-forfeitable shall be settled, unless otherwise determined by the Committee, by the Company through the delivery to the Participant of a number of shares of Common Stock equal to the number of RSUs that vested and became non-forfeitable pursuant to Section 3(a) hereof.  As a condition to the receipt of any shares of Common Stock issuable in respect of vested RSUs, the Participant shall at the request of the Company deliver to the Company one or more stock powers, duly endorsed in blank, relating to such shares of Common Stock. 

		
	(d)
	Effect of Termination of Service. Except as otherwise provided below (or as otherwise provided in an employment, consulting or other written agreement between the Participant and the Company or any of its Subsidiaries), if the Participant’s employment with the Company is terminated, the unvested portion of any RSUs shall be forfeited without consideration to the Participant on the date of termination of service.

		
	(e)
	Rights as a Stockholder; Dividends. The Participant shall not have any privileges of a stockholder of the Company with respect to any RSUs, including without limitation any right to vote any shares of Common Stock underlying such RSUs, unless and until shares of Common Stock underlying the RSUs are delivered to the Participant in accordance with Section 3(c) hereof.  If on any date while RSUs are outstanding the Company shall pay any dividend on the shares of Common Stock (other than a dividend payable in shares of Common Stock), the number of RSUs granted to the Participant shall, as of the record date for such dividend payment, be increased by a number of RSUs equal to: (a) the product of (x) the number of RSUs held by the Participant as of such record date, multiplied by (y) the per share of Common Stock amount of any cash dividend (or, in the case of any dividend 

2

payable, in whole or in part, other than in cash, the per share of Common Stock value of such dividend, as determined in good faith by the Company), divided by (b) the average closing price of a share of Common Stock on the New York Stock Exchange on the twenty (20) trading days preceding, but not including, such record date.  In the case of any dividend declared on shares of Common Stock that is payable in the form of shares of Common Stock, the number of RSUs granted to the Participant shall be increased by a number equal to the product of (1) the aggregate number of RSUs held by the Participant on the record date for such dividend, multiplied by (2) the number of shares of Common Stock (including any fraction thereof) payable as a dividend on a share of Common Stock.  Such dividends shall only be distributed or paid to the extent that the underlying RSUs vest and are settled into shares of Common Stock in accordance with Section 3(c) hereof.  In no event shall the Participant be entitled to any payments or distributions relating to dividends paid after the earlier to occur of the settlement or forfeiture of the applicable RSUs and, for the avoidance of doubt, all accumulated dividends shall be forfeited immediately upon the forfeiture or cancellation of the underlying RSUs or applicable portion thereof.
		
	(f)
	Taxes and Withholding. The Participant shall be responsible for all income taxes payable in respect of the RSUs. Upon the issuance of any shares of Common Stock underlying the RSUs (or, if applicable, the payment of an amount in cash equal to the value thereof), the Participant shall be required to pay to the Company, and the Company shall have the right and is hereby authorized to withhold any cash, shares of Common Stock, other securities or other property deliverable under the RSUs or from any compensation or other amounts owing to a Participant, the amount (in cash, Common Stock, other securities or other property) of any required withholding taxes in respect of the RSUs, and to take such other action as may be necessary in the opinion of the Committee to satisfy all obligations for the payment of such withholding taxes, if applicable. In addition, the Committee may, in its sole discretion, permit a Participant to satisfy, in whole or in part, the foregoing withholding liability by (A) the delivery of shares of Common Stock (which are not subject to any pledge or other security interest and which would not result in adverse accounting to the Company) owned by the Participant having a Fair Market Value equal to such withholding liability or (B) having the Company withhold from the number of shares of Common Stock otherwise issuable or deliverable pursuant to the vesting and settlement of the RSUs, a number of shares with a Fair Market Value equal to such withholding liability (but not to exceed an amount that would result in adverse accounting to the Company). The obligations of the Company under this Agreement will be conditional on such payment or arrangements, and the Company will, to the extent permitted by law, have the right to deduct any such withholding taxes from any payment of any kind otherwise due to Participant.

3

		
	4.
	Miscellaneous.

		
	(a)
	Notices. All notices, demands and other communications provided for or permitted hereunder shall be made in writing and shall be by registered or certified first-class mail, return receipt requested, telecopier, courier service or personal delivery:

if to the Company:

HC2 Holdings, Inc.
450 Park Avenue, 30th Floor
New York, NY  10022
Attention: Chief Legal Officer
E-mail: probinson@hc2.com

if to the Participant, at the Participant’s last known address on file with the Company.

All such notices, demands and other communications shall be deemed to have been duly given when delivered by hand, if personally delivered; when delivered by courier, if delivered by commercial courier service; five business days after being deposited in the mail, postage prepaid, if mailed; and when receipt is mechanically acknowledged, if telecopied.
		
	(b)
	Clawback/Forfeiture. If the Participant receives any amount in excess of what the Participant should have received with respect to the RSUs for any reason (including without limitation by reason of a financial restatement, mistake in calculations or other administrative error), then the Participant shall be required to repay any such excess amount to the Company upon 30 days prior written demand by the Committee. To the extent required by applicable law (including without limitation Section 304 of the Sarbanes Oxley Act and Section 954 of the Dodd Frank Act), the RSUs, and any property paid or issued in respect of any portion of the RSUs, shall be subject to any required clawback, forfeiture or similar requirement.

		
	(c)
	Severability. The invalidity or unenforceability of any provision of this Agreement shall not affect the validity or enforceability of any other provision of this Agreement, and each other provision of this Agreement shall be severable and enforceable to the extent permitted by law.

		
	(d)
	No Rights to Service. Nothing contained in this Agreement shall be construed as giving the Participant any right to be retained, in any position as an employee, consultant or director of the Company or its Affiliates or shall interfere with or restrict in any way the rights of the Company or its Affiliates, which are hereby expressly reserved, to remove, terminate or discharge the Participant at any time for any reason whatsoever.

4

		
	(e)
	Bound by Plan. By signing this Agreement, the Participant acknowledges that he has received a copy of the Plan and has had an opportunity to review the Plan and agrees to be bound by all the terms and provisions of the Plan.

		
	(f)
	Beneficiary. The Participant may file with the Committee a written designation of a beneficiary on such form as may be prescribed by the Committee and may, from time to time, amend or revoke such designation. If no designated beneficiary survives the Participant, the executor or administrator of the Participant’s estate shall be deemed to be the Participant’s beneficiary.

		
	(g)
	Successors. The terms of this Agreement shall be binding upon and inure to the benefit of the Company, its successors and assigns, and the Participant and the beneficiaries, executors, administrators, heirs and successors of the Participant.

		
	(h)
	Section 409A. It is intended that the RSUs be exempt from or comply with Section 409A of the Code and this Agreement shall be interpreted consistent therewith.  This Agreement is subject to Section 15(u) of the Plan.

		
	(i)
	Electronic Delivery. By executing this Agreement, the Participant hereby consents to the electronic delivery of prospectuses, annual reports and other information required to be delivered by Securities and Exchange Commission rules. This consent may be revoked in writing by the Participant at any time upon three business days’ notice to the Company, in which case subsequent prospectuses, annual reports and other information will be delivered in hard copy to the Participant.

		
	(j)
	Securities Laws. The Participant agrees that the obligation of the Company to issue Restricted Shares shall also be subject, as conditions precedent, to compliance with applicable provisions of the Securities Act of 1933, as amended, the Securities Exchange Act of 1934, as amended, state securities or corporation laws, rules and regulations under any of the foregoing and applicable requirements of any securities exchange upon which the Company’s securities shall be listed.

		
	(k)
	Entire Agreement. This Agreement and the Plan contain the entire agreement and understanding of the parties hereto with respect to the subject matter contained herein and supersede all prior communications, representations and negotiations in respect thereto. No change, modification or waiver of any provision of this Agreement shall be valid unless the same be in writing and signed by the parties hereto.

		
	(l)
	Governing Law. This Agreement shall be construed and interpreted in accordance with the laws of the State of Delaware without regard to principles of conflicts of law thereof, or principals of conflicts of laws of any other 

5

jurisdiction which could cause the application of the laws of any jurisdiction other than the State of Delaware.
		
	(m)
	Headings. The headings of the Sections hereof are provided for convenience only and are not to serve as a basis for interpretation or construction, and shall not constitute a part, of this Agreement.

		
	(n)
	Signature in Counterparts. This Agreement may be signed in counterparts, each of which shall be an original, with the same effect as if the signatures thereto and hereto were upon the same instrument.

[Signatures on next page]

6

IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the date first set forth above.
HC2 Holdings, Inc.

By:                            
Michael J. Sena
Chief Financial Officer
Dated:                  

                            
[Insert Name of Participant]
Dated:                      

[Signature page to Restricted Stock Unit Award Agreement of [Insert Name of Participant]]

7

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