Exhibit 10.2


 





Execution


 


Confidential Materials Omitted and Filed
Separately with the Securities and Exchange 


Commission Pursuant to a Request for Confidential
Treatment under Rule 406 under the


Securities Act of 1933, as amended. Confidential
Portions are marked: [***]


 


ASSET PURCHASE AGREEMENT


 


By and between


 


Merck
Sharp & Dohme B.V. 


 


and


 


ANI PHARMACEUTICALS, INC.


 


Dated as of September 18, 2015


 






     


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

 


TABLE OF CONTENTS


 


	ARTICLE 1	DEFINITIONS	1
	 	 	 	 
	 	1.1	Certain Defined Terms	1
	 	1.2	Construction	8
	 	 	 	 
	ARTICLE 2	SALE AND PURCHASE OF ASSETS AND LIABILITIES	8
	 	 	 	 
	 	2.1	Sale of Purchased Assets	8
	 	2.2	Liabilities	8
	 	2.3	Consideration	9
	 	2.4	Closing	14
	 	 	 	 
	ARTICLE 3	REPRESENTATIONS AND WARRANTIES	15
	 	 	 	 
	 	3.1	Representations and Warranties of Seller	15
	 	3.2	Exclusivity of Representations	18
	 	3.3	Representations and Warranties of Buyer	18
	 	 	 	 
	ARTICLE 4	PRE-CLOSING COVENANTS	19
	 	 	 	 
	 	4.1	Access and Information	19
	 	4.2	Ordinary Course of Business	20
	 	4.3	Obligation to Consummate the Transaction	20
	 	4.4	Competition Filings	20
	 	 	 	 
	ARTICLE 5	ADDITIONAL COVENANTS AND AGREEMENTS	22
	 	 	 	 
	 	5.1	Further Assurances	22
	 	5.2	Publicity	22
	 	5.3	Confidentiality	23
	 	5.4	FDA Letters	24
	 	5.5	Regulatory Responsibilities	24
	 	5.6	Pharmacovigilance	25
	 	5.7	Certain Tax Matters	25
	 	5.8	Insurance	26
	 	5.9	FCPA	27
	 	5.10	Wrong Pockets	28
	 	5.11	Licensed Manufacturing Technology	28
	 	 	 	 
	ARTICLE 6	CONDITIONS PRECEDENT	29
	 	 	 	 
	 	6.1	Conditions to Obligations of Buyer and Seller	29
	 	6.2	Conditions to Obligations of Buyer	29
	 	6.3	Conditions to Obligations of Seller	30


 




    i 


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

 


	 	6.4	Frustration of Closing Conditions	30
	 	 	 	 
	ARTICLE 7	INDEMNIFICATION	30
	 	 	 	 
	 	7.1	Indemnification	30
	 	7.2	Claim Procedure	31
	 	7.3	Limitations on Indemnification	33
	 	7.4	Tax Treatment of Indemnification Payments	34
	 	7.5	Exclusive Remedy	34
	 	7.6	Setoff Rights	34
	 	7.7	Disclaimer	35
	 	 	 	 
	ARTICLE 8	TERMINATION	35
	 	 	 	 
	 	8.1	Termination	35
	 	8.2	Procedure and Effect of Termination	36
	 	 	 	 
	ARTICLE 9	MISCELLANEOUS	36
	 	 	 	 
	 	9.1	Governing Law, Jurisdiction, Venue and Service	36
	 	9.2	Notices	37
	 	9.3	No Benefit to Third Parties	38
	 	9.4	Waiver and Non-Exclusion of Remedies	39
	 	9.5	Expenses	39
	 	9.6	Assignment	39
	 	9.7	Amendment	39
	 	9.8	Severability	39
	 	9.9	Equitable Relief	40
	 	9.10	English Language	40
	 	9.11	Bulk Sales Statutes	40
	 	9.12	Counterparts	40
	 	9.13	Entire Agreement	40


  




    ii 


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

 


EXHIBITS


 


	Exhibit A	Form of Bill of Sale and Assignment and Assumption Agreement
	Exhibit B	Form of Buyer FDA Transfer Letters
	Exhibit C	Form of Seller FDA Transfer Letters
	Exhibit D	Form of Trademark Assignment
	 	 
	SCHEDULES	 
	 	 
	Schedule 1.1.34	Licensed Manufacturing Technology
	Schedule 1.1.46	Purchased Documents
	Schedule 1.1.50	Seller’s Knowledge
	Schedule 2.3.2(a)	Contingent Payments
	Schedule 4.2	Ordinary Course of Business


 




    iii 


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

 


INDEX OF DEFINED TERMS


 


	Accountants	1	 	Excluded Liabilities	3
	Act	1	 	Exploit	3
	Affiliate	1	 	Exploitation	3
	Agreement	1	 	FCPA	27
	Allocation	14	 	FDA	3
	Ancillary Agreements	2	 	FDA Transfer Date	24
	Annual Net Sales Report	11	 	First Commercial Sale	3
	Applicable Courts	37	 	GAAP	3
	Assumed Liabilities	2	 	Global Safety Database	25
	Bill of Sale	2	 	Governmental Authority	4
	Business Day	2	 	Indemnification Certificate	31
	Buyer	1, 2, 10	 	Indemnified Party	31
	Buyer Confidential Information	23	 	Indemnifying Party	31
	Buyer FDA Transfer Letters	2	 	Law	4
	Buyer Indemnitees	31	 	Liabilities	4
	Buyer Material Adverse Effect	2	 	Licensed Manufacturing Technology	4
	Buyer Permitted Purpose	24	 	Liens	4
	Buyer Related Party	2	 	Litigation	4
	Calendar Quarter	2	 	Loss	4
	Calendar Year	2	 	Losses	4
	Claim Notice	32	 	Material Adverse Effect	4
	Closing	14	 	Monthly Net Sales Report	11
	Closing Payment	9	 	NDA	5
	Code	2	 	Net Sales	5
	Combination Product	2	 	Net Sales Forecast	12
	Confidential Information	22	 	Net Sales Information	12
	Confidential Net Sales Information	23	 	Non-Controlling Party	32
	Confidentiality Agreement	3	 	Notice	37
	Consents	17	 	Officials	27
	Contingent Payment	9	 	Parties	1
	Contract	3	 	Party	1
	Controlling Party	32	 	Payment	27
	Corticotropin	3	 	Permitted Lien	6
	Corticotropin Zinc Hydroxide	3	 	Person	6
	Diligent Efforts	3	 	Pre-Closing Period	19
	Disclosing Party	22	 	Products	6
	Disclosure Schedules	3	 	Purchase Price	6
	Dispute Notice	13	 	Purchased Assets	8
	Dispute Response	13	 	Purchased Documents	6
	Effect	4	 	Purchased Regulatory Approvals	6
	Effective Date	1	 	Purchased Trademark Applications	6
	Estimated Monthly Net Sales Report	10	 	Quarterly Net Sales Report	11
	Excluded Assets	3	 	Receiving Party	22


 




    iv 


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

 


	Representatives	19	 	Tax Return	7
	Seller	1, 2, 10	 	Taxes	7
	Seller Confidential Information	24	 	Territory	7
	Seller FDA Transfer Letters	6	 	Third Party	7
	Seller Indemnitees	31	 	Trade Secrets	7
	Seller Permitted Purpose	23	 	Trademark	7
	Seller’s Knowledge	6	 	Trademark Assignment	7
	Specified Affiliate	15	 	Transfer Taxes	26
	Subject Products	6	 	U.S. Territory	7
	Sublicensee	28	 	 	 


 




    v 


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

 


ASSET PURCHASE AGREEMENT


 


This Asset Purchase Agreement (this “Agreement”)
is made and executed as of September 18, 2015 (the “Effective Date”), by and between Merck Sharp & Dohme
B.V., a limited liability company (a Besloten Vennootschap) organized and existing under the Laws of the Netherlands (“Seller”),
and ANI Pharmaceuticals, Inc., a Delaware corporation (“Buyer”). Seller and Buyer are sometimes referred to
herein individually as a “Party” and collectively as the “Parties.”


 


RECITALS


 


WHEREAS, Seller wishes to sell and transfer
to Buyer, and Buyer desires to purchase and assume from Seller, the Purchased Assets and the Assumed Liabilities, upon the terms
and conditions hereinafter set forth.


 


NOW, THEREFORE, in consideration of the
mutual benefits to be derived from this Agreement and of the representations, warranties, conditions, agreements and promises contained
herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending
to be legally bound, hereby agree as follows:


 


DEFINITIONS


 


1.1         Certain
Defined Terms. As used herein, the following terms shall have the following meanings:


 


1.1.1         “Accountants”
means an accounting firm of national reputation in the United States (excluding each of Seller’s and its Affiliates’
and Buyer’s and its Affiliates’ respective regular outside accounting firms) mutually acceptable to Seller and Buyer;
provided, however, if Seller and Buyer are unable to agree on such accounting firm within 10 calendar days or any
such mutually selected accounting firm is unwilling or unable to serve, then Seller shall deliver to Buyer a list of three other
accounting firms of national reputation in the United States that have not performed services for Seller or its Affiliates or Buyer
or its Affiliates in the preceding three years, and Buyer shall select one of such three accounting firms.


 


1.1.2         “Act”
means the United States Federal Food, Drug, and Cosmetic Act.


 


1.1.3         “Affiliate”
means, with respect to a Person, any other Person that, directly or indirectly, through one or more intermediaries, controls, is
controlled by or is under common control with such first Person. For purposes of this definition, “control” and, with
correlative meanings, the terms “controlled by” and “under common control with” mean (a) the possession,
directly or indirectly, of the power to direct the management or policies of a business entity, whether through the ownership of
voting securities, by contract relating to voting rights or corporate governance, or otherwise or (b) the ownership, directly
or indirectly, of at least 50% of the voting securities or other ownership interest of a business entity (or, with respect to a
limited partnership or other similar entity, its general partner or controlling entity).


 




     1


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

 


1.1.4         “Ancillary
Agreements” means the Bill of Sale and the Trademark Assignment.


 


1.1.5         “Assumed
Liabilities” means all Liabilities of Seller or any of its Affiliates under or relating to the Purchased Assets and all
Liabilities arising out of or related to the Exploitation of the Products or the exercise by Buyer, its Affiliates or any Sublicensee
of the license to the Licensed Manufacturing Technology granted pursuant to Section 5.11, in each case, excluding the Excluded
Liabilities.


 


1.1.6         “Bill
of Sale” means that certain Bill of Sale and Assignment and Assumption Agreement, in substantially the form of Exhibit
A.


 


1.1.7         “Business
Day” means any day other than Saturday, Sunday or a day on which banking institutions in New York, New York are permitted
or obligated by Law to remain closed.


 


1.1.8         “Buyer
FDA Transfer Letters” means the letters to the FDA in the form of Exhibit B, indicating Buyer’s acceptance
of the rights to the Purchased Regulatory Approvals from Seller.


 


1.1.9         “Buyer
Material Adverse Effect” means any event, fact, condition, occurrence, change or effect that prevents the consummation
by Buyer of the transactions contemplated by this Agreement or the Ancillary Agreements.


 


1.1.10       “Buyer
Related Party” means any licensee or sublicensee of Buyer or any of Buyer’s Affiliates.


 


1.1.11       “Calendar
Quarter” means the respective periods of three consecutive calendar months ending on March 31, June 30, September 30
and December 31, except that the first Calendar Quarter under this Agreement with respect to a Product shall commence on the date
of the First Commercial Sale thereof and end on the first March 31, June 30, September 30 or December 31 to occur after such date.


 


1.1.12       “Calendar
Year” means each successive period of 12 calendar months commencing on January 1 and ending on December 31, except that
the first Calendar Year under this Agreement with respect to a Product shall commence on the on the date of the First Commercial
Sale thereof and end on December 31 of the year in which such date occurs.


 


1.1.13       “Closing
Date” means the date on which the Closing occurs in accordance with Section 2.4.1.


 


1.1.14       “Code”
means the Internal Revenue Code of 1986.


 


1.1.15       “Combination
Product” means any pharmaceutical product containing as active ingredients (a) an active ingredient in Corticotropin
or Corticotropin Zinc Hydroxide and (b) one or more other pharmaceutically active ingredients.


 




     2


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

 


1.1.16       “Competition
Laws” means the HSR Act and other similar Laws of any jurisdiction that are designed or intended to prohibit, restrict
or regulate actions having an anticompetitive effect or purpose.


 


1.1.17       “Confidentiality
Agreement” means that certain Three-Way Confidential Disclosure Agreement, dated March 2, 2015, by and among Merck Sharp
& Dohme Corp., [***] and ANI Pharmaceuticals, Inc.


 


1.1.18       “Contract”
means any contract, agreement, lease, sublease, license, sublicense or other legally binding commitment or arrangement.


 


1.1.19       
“Corticotropin” means the strengths and package sizes and types of the pharmaceutical product specified in NDA
#8975, including all supplements thereto.


 


1.1.20       “Corticotropin
Zinc Hydroxide” means the strengths and package sizes and types of the pharmaceutical product specified in NDA #9854,
including all supplements thereto.


 


1.1.21       “Diligent
Efforts” means [***].


 


1.1.22       “Disclosure
Schedules” means the disclosure schedules of Seller related to the representations and warranties of Seller set forth
in Section 3.1.


 


1.1.23       “Excluded
Assets” means the Licensed Manufacturing Technology and all other assets, property, rights and interests of Seller and
its Affiliates other than the Purchased Assets.


 


1.1.24       “Excluded
Liabilities” means all Liabilities of Seller or any of its Affiliates to the extent arising out of units of Products
manufactured or sold prior to the Closing Date.


 


1.1.25       “Exploit”
or “Exploitation” means to make, have made, manufacture, import, export, use, sell, offer for sale, have sold,
research, develop, commercialize, hold or keep (whether for disposal or otherwise), transport, distribute, promote, market, or
otherwise dispose of.


 


1.1.26       “FDA”
means the United States Food and Drug Administration and any successor agency thereto.


 


1.1.27       “First
Commercial Sale” means, with respect to a Subject Product, the first purchase and sale for monetary value to any Third
Party (other than a Buyer Related Party) after the Closing Date.


 


1.1.28       “GAAP”
means generally accepted accounting principles in the United States, consistently applied.


 




     3


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

 


1.1.29       “Governmental
Authority” means any supranational, international, federal, state or local court, administrative agency or commission
or other governmental authority or instrumentality, domestic or foreign, including the FDA and any corresponding foreign agency.


 


1.1.30       “HSR
Act” means the U.S. Hart-Scott-Rodino Antitrust Improvements Act of 1976.


 


1.1.31       “Intellectual
Property” means any or all rights in and to intellectual property, whether owned or held for use, including (a) patents,
inventions, invention disclosures, discoveries and improvements, whether or not patentable, Trade Secrets, copyrights, Trademarks
and domain names or uniform resource locators, in each case including any registrations of, applications or register and renewals,
modifications and extensions of, any of the foregoing, with or by any Governmental Authority in the United States or, the case
of domain names or uniform resource locators, with or by any registry of the same and (b) any rights equivalent to any of the foregoing
anywhere in the United States.


 


1.1.32       
“Law” means any domestic or foreign, federal, state or local statute, law, treaty, judgment, ordinance, rule,
administrative interpretation, regulation, order or other requirement having the force of law of any Governmental Authority.


 


1.1.33       “Liabilities”
means any debts, liabilities, obligations, commitments, claims or complaints, whether accrued or fixed, known or unknown, fixed
or contingent, determined or determinable (including all adverse reactions, recalls, product and packaging complaints and other
liabilities) and whether or not the same would be required to be reflected in financial statements or disclosed in the notes thereto.


 


1.1.34       “Licensed
Manufacturing Technology” means all technical, scientific and other know-how and information described on Schedule
1.1.34.


 


1.1.35       “Liens”
means, with respect to any Purchased Asset, any lien, security interest, mortgage, pledge, assessment, hypothecation, easement,
title retention clause, or other encumbrance, or any Contract to give any of the foregoing.


 


1.1.36       “Litigation”
means any claim, action, arbitration, mediation, hearing, proceeding, suit, warning letter, or notice of violation.


 


1.1.37       “Loss”
or “Losses” means any Liabilities, losses, damages, judgments, fines, penalties, amounts paid in settlement
and reasonable costs and expenses incurred in connection therewith, including reasonable costs and expenses of suits and proceedings,
and reasonable fees and disbursements of counsel.


 




     4


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

 


1.1.38       “Material
Adverse Effect” means an event, fact, condition, occurrence, change or effect (“Effect”) that, considered
together with all other Effects, (a) is, or would reasonably be expected to be, materially adverse to the Purchased Assets
and the Assumed Liabilities, taken as a whole, or (b) prevents the consummation by Seller of the transactions contemplated
by this Agreement or the Ancillary Agreements; provided, however, that none of the following, and no Effects resulting
from the following, shall be deemed (individually or in combination) to constitute, or shall be taken into account in determining
whether there has been, a “Material Adverse Effect”: (i) political or economic conditions or conditions affecting
the capital or financial markets generally; (ii) conditions generally affecting any industry or industry sector in which the
Products, individually or in the aggregate, are Exploited, including increases in operating costs; (iii) any change in accounting
requirements or applicable Law; (iv) any hostility, act of war, sabotage, terrorism or military actions, or any escalation
of any of the foregoing; (v) any hurricane, flood, tornado, earthquake or other natural disaster or force majeure event; (vi) the
failure of the Products, individually or in the aggregate, to achieve any financial projections, predictions or forecasts (provided,
that the underlying causes of such failure shall not be excluded); (vii) the public announcement, execution or delivery of this
Agreement or the pendency of the transactions contemplated hereby; (viii) Seller’s or any of its Affiliates’ actions
to the extent (A) required by the terms and conditions of this Agreement, (B) that Buyer has requested in writing Seller or its
Affiliates take such actions or (C) to which Buyer has consented in writing; and (ix) any matter attributable to the regulatory
status of Buyer or any of its Affiliates; except, in each of clauses (i) through (iii), for those Effects that have a disproportionate
effect on the Purchased Assets and Assumed Liabilities, taken as a whole, relative to other Persons operating businesses in the
industry or industry sector in which the Products, individually or in the aggregate, are Exploited.


 


1.1.39       “NDA”
means a New Drug Application as defined in the Act.


 


1.1.40       “Net
Sales” means the gross invoice price (not including value added Taxes, sales Taxes, or similar Taxes) of Subject Product
sold by a Payment Obligor to a Third Party (other than a Buyer Related Party) after deducting, if not previously deducted, from
the amount invoiced or received:


 


(a)        trade
and quantity discounts other than early payment cash discounts;


 


(b)        returns,
recalls, rebates, chargebacks and other allowances;


 


(c)        retroactive
price reductions that are actually allowed or granted; and


 


(d)        early
payment cash discounts, transportation and insurance and custom duties.


 


Notwithstanding the foregoing, transfers or
dispositions of Subject Products by or on behalf of Buyer or any of its Affiliates for patient assistance programs, research or
development or complimentary samples shall not in each case be deemed “sales” for the purposes of calculating Net Sales.


 


1.1.41       
“Payment Obligor” means Buyer, its Affiliates, and each of Buyer’s and its Affiliates’ licensees,
sublicensees and distributors with respect to any Subject Product.


 




     5


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

 


1.1.42       “Permitted
Lien” means any (a) Lien approved in writing by Buyer as a Permitted Lien, (b) title defect or irregularity affecting
the Purchased Assets, that, individually or in the aggregate, would not reasonably be expected to detract from the value or impair
the use of the asset subject thereto, (c) Lien for Taxes not yet due or delinquent, and (d) Lien caused by Law for amounts not
material or overdue that does not or would not be reasonably expected to materially detract from the current value of, or materially
interfere with, the present use and enjoyment of any Purchased Asset subject thereto.


 


1.1.43       “Person”
means any individual, partnership, limited partnership, limited liability company, joint venture, syndicate, sole proprietorship,
corporation, unincorporated association, trust, trustee, executor, administrator or other legal personal representative, or any
other legal entity, including a Governmental Authority.


 


1.1.44       “Products”
means, collectively, Corticotropin and Corticotropin Zinc Hydroxide, and “Product” means either of the foregoing.


 


1.1.45       “Purchase
Price” means the sum of the Closing Payment, and to the extent actually paid by Buyer in accordance with Section 2.3.2,
the Contingent Payments.


 


1.1.46       “Purchased
Documents” means the documents set forth on Schedule 1.1.46.


 


1.1.47       
“Purchased Regulatory Approvals” means NDA #8975 and NDA #9854 and all supplements to either such NDA.


 


1.1.48       
“Purchased Trademark Applications” means, collectively, U.S. Trademark application for the Trademark CORTROPHIN,
U.S. Serial No. 86534100 and the U.S. Trademark application for the Trademark CORTROPHIN-ZINC, U.S. Serial No. 86534102, both for
“medicinal hormone preparation.”


 


1.1.49       
“Seller FDA Transfer Letters” means the letters to the FDA in the form of Exhibit C, transferring the
rights to the Purchased Regulatory Approvals to Buyer.


 


1.1.50       “Seller’s
Knowledge” means the actual knowledge the individuals listed on Schedule 1.1.50 have or would have following reasonable
inquiry into the subject matter in the course of performing their respective duties.


 


1.1.51       “Subject
Products” means, collectively, (a) the Products, (b) Combination Products and (c) any line extensions, synthetic versions,
other administration forms, presentations, dosages, formulations, back-ups, improvements or next generation products for or of
any Product or Combination Product, whether prescription or over-the-counter; provided, that any product described in any
of the preceding clauses (a) through (c) that is sold by a Payment Obligor to a Third Party (other than a Buyer Related Party)
in any country outside of the U.S. Territory shall be a Subject Product only if the regulatory approval pursuant to which such
product is distributed, marketed or sold references, incorporates or relies upon, in whole or in material part, any of the Purchased
Assets, including any data contained therein.


 




     6


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

 


1.1.52       “Tax
Return” means any return, declaration, report, claim for refund, information return or statement relating to Taxes, including
any schedule or attachment thereto, filed or maintained, or required to be filed or maintained, in connection with the calculation,
determination, assessment or collection of any Tax and includes any amended returns required as a result of examination adjustments
made by the Internal Revenue Service or other Tax authority.


 


1.1.53       “Taxes”
means all taxes of any kind including all U.S. federal, state, local or non-U.S. net income, capital gains, gross income, gross
receipt, property, franchise, sales, use, excise, withholding, payroll, employment, social security, worker’s compensation,
unemployment, occupation, capital stock, transfer, gains, windfall profits, net worth, asset, transaction and other taxes, and
any interest, penalties or additions to tax with respect thereto, imposed upon any Person by any taxing authority or other Governmental
Authority under applicable Law.


 


1.1.54       “Territory”
means worldwide.


 


1.1.55       “Third
Party” means any Person other than Seller, Buyer and their respective Affiliates and permitted successors and assigns.


 


1.1.56       “Trademark”
means any word, name, symbol, color, product shape, designation or device or any combination thereof that functions as a source
identifier, including any trademark, trade dress, brand mark, service mark, trade name, brand name, product configuration, logo
or business symbol, whether or not registered, and all goodwill associated therewith and symbolized thereby.


 


1.1.57       “Trademark
Assignment” means that certain Trademark Assignment Agreement, in substantially the form of Exhibit D.


 


1.1.58       “Trade
Secret” means information that derives independent economic value from not being generally known to, and not being readily
ascertainable by proper means by, other Persons that can obtain economic value from its disclosure or use.


 


1.1.59       “U.S.
Territory” means the United States and its territories and possessions.


 




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Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

 


1.2         Construction.
Except where the context otherwise requires, wherever used, the singular includes the plural, the plural the singular, the use
of any gender shall be applicable to all genders and the word “or” is used in the inclusive sense (and/or). The captions
of this Agreement are for convenience of reference only and in no way define, describe, extend or limit the scope or intent of
this Agreement or the intent of any provision contained in this Agreement. The term “including” as used herein does
not limit the generality of any description preceding such term. The language of this Agreement shall be deemed to be the language
mutually chosen by the Parties and no rule of strict construction shall be applied against either Party. Unless otherwise specified
or where the context otherwise requires, (a) references in this Agreement to any Article, Section, Schedule or Exhibit are
references to such Article, Section, Schedule or Exhibit of this Agreement; (b) references in any Section to any clause are
references to such clause of such Section; (c) “hereof,” “hereto,” “hereby,” “herein”
and “hereunder” and words of similar import when used in this Agreement refer to this Agreement as a whole and not
to any particular provision of this Agreement; (d) references to a Person are also to its permitted successors and assigns;
(e) references to a Law include any amendment or modification to such Law and any rules or regulations issued thereunder,
in each case, as in effect at the relevant time of reference thereto; (f) references to any agreement, instrument or other
document in this Agreement refer to such agreement, instrument or other document as originally executed or, if subsequently amended,
replaced or supplemented from time to time, as so amended, replaced or supplemented and in effect at the relevant time of reference
thereto; (g) “extent” in the phrase “to the extent” means the degree to which a subject or other thing
extends, and such phrase does not mean simply “if”; and (h) references to monetary amounts are denominated in
United States Dollars.


 


SALE AND PURCHASE OF
ASSETS AND LIABILITIES 


 


2.1         Sale
of Purchased Assets.


 


2.1.1         Purchase
and Sale of Purchased Assets. Upon the terms and subject to the conditions of this Agreement and the Ancillary Agreements,
at and effective as of the Closing, Seller shall (or shall cause its applicable Affiliates to) sell, transfer, convey, assign and
deliver to Buyer, and Buyer shall purchase and accept from Seller (or such Affiliates), all rights and interests of Seller or its
Affiliates to or in the following (collectively, the “Purchased Assets”), free and clear of any Liens other
than Permitted Liens:


 


(a)        the
Purchased Regulatory Approvals;


 


(b)        the
Purchased Documents; and


 


(c)        the
Purchased Trademark Applications.


 


2.1.2         Excluded
Assets. Buyer shall not acquire pursuant to this Agreement or any Ancillary Agreement, and Seller shall retain following the
Closing, the Excluded Assets.


 


2.2         Liabilities.


 


2.2.1         Assumed
Liabilities. Upon the terms and subject to the conditions of this Agreement, at the Closing, Seller shall assign and Buyer
shall unconditionally assume and agree to pay and discharge when due the Assumed Liabilities.


 


2.2.2         Excluded
Liabilities. Buyer shall not assume any Liabilities of Seller or any of its Affiliates other than the Assumed Liabilities,
including the Excluded Liabilities, and the Excluded Liabilities shall remain the sole obligation and responsibility of Seller
and its Affiliates.


 




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Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

 


2.3         Consideration.



 


2.3.1         Consideration.
In consideration for the Purchased Assets, Buyer shall pay to Seller (a) Seventy Five Million Dollars ($75,000,000) (the “Closing
Payment”) to be paid on the Closing Date by wire transfer of immediately available funds to the account or accounts designated
by Seller by written notice to Buyer, and (b) the Contingent Payments, as and to the extent provided in Section 2.3.2.


 


2.3.2         Contingent
Consideration.


 


(a)        Buyer
shall pay to Seller as additional consideration hereunder a percentage of Net Sales of all Subject Products in the Territory in
each Calendar Year as set forth on Schedule 2.3.2(a) (each, a “Contingent Payment”).


 


(b)        Buyer
shall pay Seller the applicable Contingent Payments within 30 calendar days after the end of each Calendar Quarter. All calculations
of Contingent Payments shall be subject to quarterly adjustments by Buyer following the preparation of its unaudited quarterly
financial statements as follows:


 


(i)        In
the event Buyer determines that it made Contingent Payments to Seller in respect of any prior Calendar Quarter in excess of the
correct Contingent Payment applicable thereto, Buyer shall promptly advise Seller of its determination and, subject to Section
2.3.4(g) below, shall be entitled to deduct the amount of such overpayments from the Contingent Payments due to Seller for the
following Calendar Quarter (and, if applicable, successive Calendar Quarters until the amount of the overpayment has been reduced
to $0).


 


(ii)       In
the event Buyer determines that additional Contingent Payments are due to Seller in respect of the Contingent Payments applicable
to any prior Calendar Quarter, then it shall promptly advise Seller of its determination and, subject to Section 2.3.4(g) below,
pay over such amounts to Seller no later than (A) 30 calendar days following Buyer’s filing of its unaudited quarterly financial
statements with the U.S. Securities and Exchange Commission or (B) if Buyer is not required to file financial statements with the
U.S. Securities and Exchange Commission, no later than 75 calendar days following the end of the Calendar Quarter for which such
Contingent Payments are payable.


 


(c)        In
addition to quarterly adjustments pursuant to Section 2.3.2(b), all calculations of Contingent Payments shall be subject to an
annual adjustment by Buyer following the preparation of its audited annual financial statements as follows:


 


(i)        In
the event that, after giving effect to any adjustments made pursuant to Section 2.3.2(b), Buyer determines that it made Contingent
Payments to Seller in respect of any prior Calendar Year in excess of the correct Contingent Payment applicable thereto, Buyer
shall promptly advise Seller of its determination and, subject to Section 2.3.4(g) below, shall be entitled to deduct the amount
of such overpayments from the Contingent Payments due to Seller for the first Calendar Quarter following such Calendar Year (and,
if applicable, successive Calendar Quarters until the amount of the overpayment has been reduced to $0).


 




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(ii)       In
the event that, after giving effect to any adjustments made pursuant to Section 2.3.2(b), Buyer determines that additional Contingent
Payments are due to Seller in respect of the Contingent Payments applicable to any prior Calendar Year, then it shall promptly
advise Seller of its determination and, subject to Section 2.3.4(g) below, pay over such amounts to Seller no later than (A) 30
calendar days following Buyer’s filing of its audited annual financial statements with the U.S. Securities and Exchange Commission
or (B) if Buyer is not required to file financial statements with the U.S. Securities and Exchange Commission, no later than 90
calendar days following the end of the Calendar Year for which such Contingent Payments are payable.


 


(d)        Buyer
shall use good faith Diligent Efforts to Exploit the Subject Products in the Territory.


 


2.3.3         Mode
of Payment; Interest; Tax Treatment. Buyer shall pay to Seller the Contingent Payments by wire transfer of immediately available
funds to such bank account or accounts as Seller may from time to time designate by advance written notice to Buyer. All payments
to be made by Buyer to Seller under this Agreement shall be made in United States dollars. For purposes of calculating Net Sales
for any Subject Products sold in a currency other than United States dollars, the rate of exchange to be used in computing the
currency equivalent in United States dollars due to Seller shall be a well-established and widely recognized rate of exchange used
by Buyer for reporting such sales for United States financial statement purposes, consistently applied. If Buyer fails to make
any payment pursuant to this Agreement when due, any such late payment shall bear simple interest, to the extent not prohibited
by Law, at a per annum rate equal to the U.S. Prime Rate, as reported in The Wall Street Journal, Eastern Edition, for the first
date on which such payment was delinquent, plus two percent, beginning on the first date on which such payment was delinquent and
ending on the date on which such payment is made, calculated based on the actual number of days such payment is overdue. The Contingent
Payments shall be treated as an adjustment to the Purchase Price for all Tax purposes, unless otherwise required by applicable
Law and unless any portion of such Contingent Payment is required to be treated as interest in respect of deferred consideration
for Tax purposes.


 


2.3.4         Financial
Records; Audits.


 


(a)        Within
five Business Days after the end of each calendar month, commencing with the calendar month in which the First Commercial Sale
of a Subject Product occurs, Buyer shall deliver to Seller a report, solely for informational purposes, setting out estimated Net
Sales in such prior calendar month for each Subject Product, on a country-by-country basis (each, an “Estimated Monthly
Net Sales Report”), including:


 


(i)        estimated
gross amount invoiced for sales of each Subject Product sold in each country in such calendar month;


 




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Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

 


(ii)       estimated
Net Sales of each Subject Product in each country in such calendar month; and


 


(iii)        all
relevant deductions from the estimated gross amount invoiced in accordance with this Agreement to calculate such Net Sales.


 


(b)        Within
15 Business Days after the end of each calendar month, commencing with the calendar month in which the First Commercial Sale of
a Subject Product occurs, Buyer shall deliver to Seller a report setting out Net Sales in such prior calendar month for each Subject
Product, on a country-by-country basis (each, a “Monthly Net Sales Report”), including:


 


(i)        gross
amount invoiced for sales of each Subject Product sold in each country in such calendar month;


 


(ii)       Net
Sales of each Subject Product in each country in such calendar month; and


 


(iii)        all
relevant deductions from the gross amount invoiced in accordance with this Agreement to calculate such Net Sales.


 


(c)        Within
30 calendar days after the end of each Calendar Quarter, commencing with the Calendar Quarter in which the First Commercial Sale
of a Subject Product occurs, Buyer shall deliver to Seller a report setting out Net Sales in such prior Calendar Quarter for each
Subject Product, on a country-by-country basis (each, a “Quarterly Net Sales Report”), including:


 


(i)        gross
amount invoiced for sales of each Subject Product sold in each country in such Calendar Quarter;


 


(ii)       Net
Sales of each Subject Product in each country in such Calendar Quarter;


 


(iii)        all
relevant deductions from the gross amount invoiced in accordance with this Agreement to calculate such Net Sales; and


 


(iv)        a
reconciliation of the amounts set forth in the Monthly Net Sales Report delivered for the calendar month in the applicable Calendar
Quarter to the amounts set forth in the Quarterly Net Sales Report.


 


The report for the fourth Calendar Quarter of
each Calendar Year (the “Annual Net Sales Report”) shall include the items in the preceding clauses (i) through
(iii) for both such Calendar Quarter and the full Calendar Year in which such Calendar Quarter occurs and include a reconciliation
of the amounts set forth in the Quarterly Net Sales Reports delivered for the applicable Calendar Year to the amounts set forth
in the Annual Net Sales Report.


 




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(d)        Commencing
with the Calendar Year in which the First Commercial Sale of a Subject Product occurs, Buyer shall deliver to Seller a report setting
out Buyer’s forecasted Net Sales for each Subject Product on a calendar month-by-calendar month and country-by-country basis
(the “Net Sales Forecast”) according to the following schedule:


 


(i)        by
April 15 of each Calendar Year, the Net Sales Forecast for the current Calendar Year and the following four Calendar Years;


 


(ii)       by
July 15 of each Calendar Year, the Net Sales Forecast for the current Calendar Year and the following Calendar Year; and


 


(iii)        by
October 15 of each Calendar Year, the Net Sales Forecast for the current Calendar Year and the following two Calendar Years;


 


provided, however, that Buyer shall not
be required to deliver to Seller any Net Sales Forecast for a Subject Product that was due in accordance with this Section 2.3.4(d)
on a date prior to the date of the First Commercial Sale of the applicable Subject Product.


 


(e)        Each
Estimated Monthly Net Sales Report, Monthly Net Sales Report, Quarterly Net Sales Report and Annual Net Sales Report delivered
pursuant to Section 2.3.4 shall specifically set forth the amount deducted for each of the categories ((a) through (d)) in the
definition of Net Sales in this Agreement.


 


(f)        Buyer
shall, and shall cause the other Payment Obligors to, keep complete and accurate books and records pertaining to the sale, delivery
and use of the Subject Products, including books and records of Net Sales (including any deductions from the gross amount invoiced
to calculate Net Sales), to the extent required to calculate and verify all Contingent Payments payable hereunder (“Net
Sales Information”). Buyer shall, and shall cause the other Payment Obligors to, retain the Net Sales Information until
the later of [***] after the end of the period to which such Net Sales Information pertains and the expiration of the applicable
Tax statute of limitations (or any extensions thereof), or for such longer period as may be required by Law.


 


(g)        At
the request of Seller, Buyer shall, and shall cause the other Payment Obligors to, permit an independent certified public accountant
retained by Seller, during normal business hours and upon reasonable notice, to audit the Net Sales Information in order to confirm
the amount of the Contingent Payments made hereunder. Such audits may not (i) be conducted for any Calendar Quarter or Calendar
Year more than [***] after the end of such Calendar Quarter or Calendar Year, (ii) be conducted more than once in any 12-month
period (unless a previous audit with respect to the Contingent Payments for a Calendar Quarter or Calendar Year ending less than
12 months prior to the date of the request for such audit revealed an underpayment of at least [***] with respect to such period
or Buyer restates or revises such books and records for such 12-month period) or (iii) be repeated for any Calendar Quarter or
Calendar Year (unless a previous audit for such Calendar Quarter or Calendar Year revealed an underpayment of at least [***] with
respect to such period or Buyer restates or revises such books and records for such Calendar Quarter or Calendar Year). The cost
of any audit shall be borne by Seller, unless the audit reveals a variance of more than [***] from the reported amounts of the
Contingent Payments, in which case Buyer shall bear the cost of the audit. Unless disputed pursuant to Section 2.3.4(h), if such
audit concludes that additional payments with respect to the Contingent Payments were owed or that excess payments were made during
such period, Buyer shall pay the additional amounts, with interest from the date originally due as provided in Section 2.3.3, or
Seller shall reimburse such excess payments, within 30 calendar days after the date on which such audit is completed and the conclusions
thereof are notified to the Parties.


 




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(h)        In
the event of a dispute over the results of any audit conducted pursuant to Section 2.3.4(g), the disputing Party shall deliver
a dispute notice to the other Party setting forth in reasonable detail its calculation of the amounts due or owed within ten calendar
days following the completion of such audit (the “Dispute Notice”). The other Party shall deliver a response
to the Dispute Notice no later than ten calendar days following its receipt of the Dispute Notice setting forth in reasonable detail
its calculation of the amounts due or owed (the “Dispute Response”). Seller and Buyer shall work in good faith
to resolve such dispute. If the Parties are unable to reach a mutually acceptable resolution of any such dispute within 30 calendar
days of the date of notice of such dispute, then either Party shall be entitled to submit the dispute for arbitration to the Accountants,
together with copies of the Dispute Notice and the Dispute Response. The Accountants shall not be entitled to reach a decision
that is more or less than the greatest or least amounts set forth by the Parties in the Dispute Notice and Dispute Response, as
applicable. The decision of the Accountants shall be final and the costs of such arbitration as well as the initial audit shall
be borne between the Parties in such manner as the Accountants shall determine. Not later than 30 calendar days after such decision
and in accordance with such decision, Buyer shall pay the additional Contingent Payments, as applicable, with interest from the
date originally due as provided in Section 2.3.3 or Seller shall reimburse such excess payments, as applicable.


 


(i)        Seller
shall treat all information subject to review under Section 2.3.4(g) in accordance with the confidentiality provisions of Section
5.3 and (i) Seller shall cause the independent public accountant retained by Seller pursuant to Section 2.3.4(g) and (ii) Seller
and Buyer shall cause the Accountants to, as applicable, enter into a reasonably acceptable confidentiality agreement with Buyer
or its Affiliates or (sub)licensees, as the case may be, that includes an obligation to retain all such Confidential Information
(as defined in Section 5.3) in confidence.


 


2.3.5         Transfer
of Products. Any transfer, sale, license, conveyance or other disposition of any Subject Product, Purchased Regulatory Approval
or any material right (including Intellectual Property) related to a Subject Product by any Payment Obligor (other than commercial
sales of inventory of a Subject Product in the ordinary course of business) shall require that the transferee, licensee or assignee
thereof agree to be bound by the obligations with respect to the Contingent Payments set forth in this Section 2.3 and in such
case shall thereafter be deemed to be a Payment Obligor. Buyer shall remain primarily responsible for the payment of the Contingent
Payments to Seller notwithstanding any such transfer, sale, license, conveyance or other disposition; provided, that, in
connection with any such transfer, sale, license, conveyance or other disposition, Buyer may request that Seller waive Buyer’s
obligation to remain primarily responsible for the payment of the Contingent Payments, which waiver shall not be unreasonably withheld,
conditioned or delayed.


 




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Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

 


2.3.6         Allocation
of Consideration. Buyer shall allocate the Purchase Price (including the Assumed Liabilities, to the extent properly taken
into account under Section 1060 of the Code) among the Purchased Assets in accordance with Section 1060 of the Code (the “Allocation”)
prior to or within 90 calendar days following the Closing and shall deliver to Seller a copy of such Allocation (IRS Form 8594)
promptly after such determination. Seller shall have the right to review and raise any objections in writing to the Allocation
during the 10-Business Day period after its receipt thereof. If Seller disagrees with respect to any item in the Allocation, the
Parties shall negotiate in good faith to resolve the dispute. If the Parties are unable to agree on the Allocation within 30 calendar
days after the commencement of such good faith negotiations (or such longer period as Seller and Buyer may mutually agree in writing),
then the Accountants shall be engaged at that time to review the Allocation, and shall make a determination as to the resolution
of such Allocation. The determination of the Accountants regarding the Allocation shall be delivered as soon as practicable following
engagement of the Accountants, but in no event more than 60 calendar days thereafter, and shall be final, conclusive and
binding upon Seller and Buyer, and Buyer shall revise the Allocation accordingly. Seller, on the one hand, and Buyer on the other
hand, shall each pay one-half of the cost of the Accountants. The Parties agree to file all Tax Returns (including IRS Form 8594
and, if required, supplemental Forms 8594, in accordance with the instructions to Form 8594) and any other forms, reports or information
statements required to be filed pursuant to Section 1060 of the Code and the applicable regulations thereunder, and any similar
or corresponding provision of U.S. state, local or non-U.S. Tax Law, in a manner that is consistent with the finalized Allocation
and to refrain from taking any position inconsistent therewith unless required by applicable Law.


 


2.4         Closing.


 


2.4.1         Closing.
Pursuant to the terms and subject to the conditions of this Agreement, the closing of the transactions contemplated hereby (the
“Closing”) shall take place at the New York, NY offices of Covington & Burling LLP on the first Business
Day following the later of (a) five Business Days following the satisfaction of all conditions (other than those that may be or
by their terms are to be satisfied or taken at the Closing) set forth in Article 6 (or, to the extent permitted by applicable Law,
waived by the Party entitled to the benefits thereof) and (b) [***], or such other time and place, including remotely, as Buyer
and Seller may agree in writing. The Closing shall be deemed to have occurred at 12:00 a.m., eastern time, on the Closing Date,
such that Buyer shall be deemed the owner of the Purchased Assets on and after the Closing Date.


 


2.4.2         Closing
Deliveries.


 


(a)        Except
as otherwise indicated below, at the Closing, Seller shall deliver or make available, as applicable, the following to Buyer:


 




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(i)        each
of the Ancillary Agreements, validly executed by a duly authorized representative of Seller;


 


(ii)       the
Purchased Assets; provided, that (A)  all files, documents, instruments, papers, books and records included in the
Purchased Assets will be made available to Buyer only in electronic format and none of such Purchased Assets shall be delivered
to Buyer in hard copy and (B) prior to delivering or making available any files, documents, instruments, papers, books and
records to Buyer, Seller shall be entitled to redact from such files, documents, instruments, papers, books and records any information
to the extent that it does not relate to the Products; and


 


(iii)        a
certificate, dated as of the Closing Date, validly executed by a duly authorized representative of Seller, certifying that all
of the conditions set forth in Section 6.2.1 and Section 6.2.2 have been satisfied.


 


(b)        At
the Closing, Buyer shall deliver the following to Seller:


 


(i)        each
of the Ancillary Agreements, validly executed by a duly authorized representative of Buyer;


 


(ii)       the
Closing Payment in accordance with Section 2.3.1; and


 


(iii)        a
certificate, dated as of the Closing Date, validly executed by a duly authorized representative of Buyer, certifying that all of
the conditions set forth in Section 6.3.1 and Section 6.3.2 have been satisfied.


 




REPRESENTATIONS AND WARRANTIES


 


3.1         Representations
and Warranties of Seller. Seller represents and warrants to Buyer as follows, with each such representation and warranty subject
to such exceptions, if any, as are set forth in the Disclosure Schedules. Disclosures in any section or paragraph of the Disclosure
Schedules are made generally and shall not only address the corresponding section or paragraph of this Agreement, but also other
sections or paragraphs of this Agreement to the extent that it is reasonably apparent from the face of such disclosure that such
disclosure is applicable to such other sections or paragraphs.


 


3.1.1         Entity
Status. Seller is a limited liability company (a Besloten Vennootschap) duly organized, validly existing under the Laws
of the Netherlands. Each Affiliate of Seller that owns any Purchased Assets (each, a “Specified Affiliate”)
is duly organized and validly existing under the Laws of the jurisdiction of its organization. Seller and each Specified Affiliate
are duly qualified to do business and in good standing (to the extent such concept is recognized by the applicable jurisdiction)
in each jurisdiction in which the ownership of the Purchased Assets so requires, except to the extent the failure to be so qualified
and in good standing would not constitute a Material Adverse Effect.


 




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3.1.2         Authority.


 


(a)        Seller
has the requisite organizational power and authority to (i) own the Purchased Assets owned by it and (ii) enter into this Agreement
and the Ancillary Agreements to which it will be a party, to perform its obligations hereunder and thereunder and to consummate
the transactions contemplated hereby and thereby. The execution and delivery of this Agreement and the Ancillary Agreements to
which Seller will be a party and the consummation of the transactions contemplated hereby and thereby have been duly authorized
by all necessary organizational actions of Seller. This Agreement constitutes, and, when executed and delivered by Seller, each
Ancillary Agreement to which it will be a party will constitute, the valid and legally binding obligation of Seller, enforceable
against Seller in accordance with its terms, subject to bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium
or similar Laws of general application affecting or relating to the enforcement of creditors’ rights generally, and subject
to equitable principles of general applicability, whether considered in a proceeding at law or in equity.


 


(b)        Each
Specified Affiliate has the requisite entity power and authority to (i) own the Purchased Assets owned by it and (ii) enter into,
deliver and perform its obligations under each Ancillary Agreement to which it will be a party, to perform its obligations thereunder
and to consummate the transactions contemplated thereby. The execution and delivery of the Ancillary Agreements to which any Specified
Affiliate will be a party and the consummation of the transactions contemplated thereby have been duly authorized by all necessary
organizational actions of such Specified Affiliate. Each Ancillary Agreement to which a Specified Affiliate is a party, when executed
and delivered by such Specified Affiliate, will constitute the valid and legally binding obligation of such Specified Affiliate,
enforceable against such Specified Affiliate in accordance with its terms, subject to bankruptcy, insolvency, fraudulent transfer,
reorganization, moratorium or similar Laws of general application affecting or relating to the enforcement of creditors’
rights generally, and subject to equitable principles of general applicability, whether considered in a proceeding at law or in
equity.


 


3.1.3         Non-Contravention.
The execution, delivery and performance by Seller of this Agreement and each Ancillary Agreement to which it is a party, and the
execution, delivery and performance by each Specified Affiliate of each Ancillary Agreement to which it is a party, do not (a) violate
the organizational documents of Seller or such Specified Affiliate, (b) violate any Law applicable to (x) Seller or such Specified
Affiliate or (y) the Purchased Assets or (c) subject to obtaining the Consents referred to in Section 3.1.4(b), (i) violate,
breach or constitute a default under or result in the termination of any Contract to which (x) Seller or such Specified Affiliate
is a party or (y) the Purchased Assets are subject, or (ii) violate any order or judgment of a Governmental Authority to which
Seller or such Specified Affiliate is subject relating exclusively to the Purchased Assets, except, in the case of (b)(x) or (c)(i)(x),
for such violations, breaches, defaults or terminations that would not constitute a Material Adverse Effect.


 




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3.1.4         No
Litigation; Consents.


 


(a)        As
of the Effective Date, (i) there is no Litigation pending or, to Seller’s Knowledge, threatened in writing against Seller
or any of its Affiliates before any Governmental Authority relating to the Purchased Assets, and (ii) there is no order or
judgment of a Governmental Authority to which Seller or any of its Affiliates is subject relating primarily to the Purchased Assets,
except, in the case of (i) immediately above, for such Litigation, orders and judgments that would not reasonably be expected to
materially and adversely affect the Purchased Assets, taken as a whole.


 


(b)        Except
for (i) Consents that if not received, or declarations, filings or registrations that if not made, would not reasonably be expected
to materially and adversely affect the Purchased Assets, (ii) Consents, declarations or registrations that have become applicable
solely as a result of the specific regulatory status of Buyer or its Affiliates and (iii) Consents required under applicable Competition
Laws and the filing with the FDA of the Seller FDA Transfer Letters and Buyer FDA Transfer Letters, no notice to, filing with,
permit of, authorization of, exemption by, or consent of, any Governmental Authority or other Person (collectively, “Consents”)
is required for Seller to consummate the transactions contemplated hereby or by the Ancillary Agreements.


 


3.1.5         Purchased
Assets. Seller has, or one of its Specified Affiliates has, good title to, or valid contract rights in, as applicable, the
Purchased Assets, free and clear of all Liens other than Permitted Liens. This Section 3.1.5 does not relate to Intellectual Property,
which is the subject of Section 3.1.7.


 


3.1.6         Regulatory
Matters. The Purchased Regulatory Approvals are approved but in a “discontinued” state, per the definition of that
term in the Drugs@FDA Glossary of Terms. No proceeding is pending or, to Seller’s Knowledge, threatened regarding the revocation
of any Purchased Regulatory Approval. Neither Seller nor any of its Affiliates is in material violation of the terms of any Purchased
Regulatory Approval.


 


3.1.7         Intellectual
Property. Seller or a Specified Affiliate is the owner of intent-to-use applications currently pending before the United States
Patent and Trademark Office that constitute the Purchased Trademark Applications, and which are more fully identified in Section
3.1.7(a) of the Disclosure Schedules. Except as disclosed in Section 3.1.7(b) of the Disclosure Schedules, as of the Effective
Date, (i) Seller does not own, license or otherwise hold for use any material Intellectual Property in respect of or in connection
with the Purchased Assets and (ii) to Seller’s Knowledge, neither of the Purchased Trademark Applications in the U.S. Territory
is the subject of any material concurrent use or opposition proceeding or any other material Litigation.


 


3.1.8         No
Broker. There is no broker, finder or financial advisor acting or who has acted on behalf of Seller or any of its Affiliates,
who is entitled to receive any brokerage or finder’s or financial advisory fee from Buyer or any of its Affiliates in connection
with the transactions contemplated by this Agreement.


 




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3.2         Exclusivity
of Representations. BUYER ACKNOWLEDGES AND AGREES THAT, EXCEPT FOR THE EXPRESS REPRESENTATIONS AND WARRANTIES CONTAINED IN
SECTION 3.1, (A) NEITHER SELLER NOR ANY OF ITS AFFILIATES OR REPRESENTATIVES HAS MADE ANY REPRESENTATION OR WARRANTY WHATSOEVER
HEREIN OR OTHERWISE RELATED TO THE TRANSACTIONS CONTEMPLATED HEREBY AND (B) BUYER HAS NOT RELIED ON ANY REPRESENTATION OR
WARRANTY IN CONNECTION WITH THE TRANSACTIONS CONTEMPLATED HEREBY. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, BUYER ACKNOWLEDGES
AND AGREES THAT, EXCEPT AS EXPRESSLY PROVIDED IN SECTION 3.1, BUYER IS ACQUIRING THE PURCHASED ASSETS ON AN “AS IS, WHERE
IS” BASIS WITHOUT ANY EXPRESS OR IMPLIED WARRANTIES, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, INCLUDING
ANY WARRANTY AS TO QUALITY, THE FITNESS FOR A PARTICULAR PURPOSE, MERCHANTABILITY, CONDITION OF THE ASSETS OR AS TO ANY OTHER MATTER.


 


3.3         Representations
and Warranties of Buyer. Buyer represents and warrants to Seller as follows: 


 


3.3.1         Entity
Status. Buyer is a corporation duly organized, validly existing and in good standing under the Laws of the State of Delaware.
Each Affiliate of Buyer that will be a party to any Ancillary Agreement is (or as of the Closing will be) a legal entity duly organized,
validly existing and in good standing under the Laws of the jurisdiction of its organization or incorporation.


 


3.3.2         Authority.


 


(a)        Buyer
has the requisite corporate power and authority to enter into this Agreement and the Ancillary Agreements to which it will be a
party, to perform its obligations hereunder and thereunder and to consummate the transactions contemplated hereby and thereby.
The execution and delivery of this Agreement and the Ancillary Agreements to which Buyer will be a party and the consummation of
the transactions contemplated hereby and thereby have been (or prior to the Closing will have been) duly authorized by the necessary
corporate actions of Buyer. This Agreement constitutes, and, when executed and delivered by Buyer, each Ancillary Agreement to
which Buyer will be a party will constitute, the valid and legally binding obligation of Buyer, enforceable against Buyer in accordance
with its terms, subject to bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium or similar Laws of general application
affecting or relating to the enforcement of creditors’ rights generally, and subject to equitable principles of general applicability,
whether considered in a proceeding at law or in equity.


 


(b)        Each
Affiliate of Buyer that will enter into an Ancillary Agreement has (or as of the Closing will have) the requisite entity power
and authority to enter into the Ancillary Agreements to which it is a party, to perform its obligations thereunder and to consummate
the transactions contemplated thereby. The execution and delivery of the Ancillary Agreements to which any Affiliate of Buyer will
be a party and the consummation of the transactions contemplated thereby have been (or prior to the Closing will have been) duly
authorized by the necessary organizational actions of such Affiliate. Each Ancillary Agreement to which any Affiliate of Buyer
will be party, when executed and delivered by such Affiliate, will constitute the valid and legally binding obligation of such
Affiliate, enforceable against such Affiliate in accordance with its terms, subject to bankruptcy, insolvency, fraudulent transfer,
reorganization, moratorium or similar Laws of general application affecting or relating to the enforcement of creditors’
rights generally, and subject to equitable principles of general applicability, whether considered in a proceeding at law or in
equity.


 




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3.3.3         Non-Contravention.
The execution, delivery and performance by Buyer of this Agreement and of each Ancillary Agreement to which it will be a party
and the execution, delivery and performance by each Affiliate of Buyer of each Ancillary Agreement to which such Affiliate will
be a party do not (a) violate the certificate of incorporation or bylaws, or comparable organization documents, of Buyer or
such Affiliate, as applicable, (b) violate any Law or other restriction of any Governmental Authority applicable to Buyer
or such Affiliate or (c) violate, breach or constitute a default under or result in the termination of any material Contract
to which Buyer or such Affiliate is a party.


 


3.3.4         Litigation;
Consents.


 


(a)        (i)
There is no Litigation pending or, to the knowledge of Buyer, threatened against Buyer or any of its Affiliates before any Governmental
Authority, and (ii) there is no order or judgment of a Governmental Authority to which Buyer or any of its Affiliates is subject,
except for such Litigation, orders and judgments that would not reasonably be expected to have a Buyer Material Adverse Effect.


 


(b)        Except
for (i) Consents that if not received, or declarations, filings or registrations that if not made, would not reasonably be expected
to have a Buyer Material Adverse Effect and (ii) Consents required under applicable Competition Laws and the filing with the FDA
of the Seller FDA Transfer Letters and Buyer FDA Transfer Letters, no Consent of any Governmental Authority or other Person is
required for Buyer to consummate the transactions contemplated hereby or by the Ancillary Agreements.


 


3.3.5         Financial
Capacity. Buyer has immediately available cash that is sufficient to enable it to complete the transactions contemplated hereby
and to perform all of its obligations under this Agreement and the Ancillary Agreements.


 


3.3.6         No
Broker. There is no broker, finder, financial advisor or other Person acting or who has acted on behalf of Buyer or its Affiliates,
who is entitled to receive any brokerage or finder’s or financial advisory fee from Seller or any of its Affiliates in connection
with the transactions contemplated by this Agreement.


 




PRE-CLOSING COVENANTS


 


4.1         Access
and Information. During the period commencing on the Effective Date and ending on the earlier to occur of (a) the Closing
and (b) the termination of this Agreement in accordance with Article 8 (the “Pre-Closing Period”), Seller
shall afford Buyer and its officers, employees, agents, attorneys, consultants, advisors and other representatives (collectively,
“Representatives”), continued electronic access to the books and records of Seller and its Affiliates made available
to Buyer and its Representatives in an electronic data room on and prior to the Effective Date.


 




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4.2         Ordinary
Course of Business. 


 


4.2.1         During
the Pre-Closing Period, except (a) as set forth in Schedule 4.2 or as otherwise expressly required by this Agreement
or (b) as Buyer shall otherwise consent in writing, which consent shall not be unreasonably withheld, conditioned or delayed, Seller
shall and shall cause each of its Affiliates, including the Specified Affiliates (i) to maintain the Purchased Assets in the ordinary
course of business, except as otherwise required by applicable Law, and (ii) not to (A) sell, transfer or otherwise dispose of
any Purchased Assets, (B) permit any Purchased Assets to be subject to a Lien (other than a Permitted Lien) or (C) permit any Purchased
Regulatory Approval or Purchased Trademark Application to lapse or be abandoned. Nothing contained in this Agreement is intended
to give Buyer or its Affiliates, directly or indirectly, the right to control or direct the business of Seller and its Affiliates
with respect to the Purchased Assets prior to the Closing, and nothing contained in this Agreement is intended to give Seller or
its Affiliates, directly or indirectly, the right to control or direct Buyer’s operations. Prior to the Closing, each of
Buyer and its Affiliates, on the one hand, and Seller and its Affiliates, on the other hand, shall exercise, consistent with the
terms and conditions of this Agreement, complete control and supervision over its and its Affiliates’ respective operations.


 


4.2.2         [***]


 


4.3         Obligation
to Consummate the Transaction. Each Party agrees that, subject to Section 4.4, it shall use its reasonable best efforts to
take, or cause to be taken, all actions, and to do, or cause to be done, all things necessary, proper or advisable to the extent
permissible under applicable Law, to consummate and make effective the transactions contemplated by this Agreement and to ensure
that the conditions set forth in Article 6 are satisfied, insofar as such matters are within such Party’s control.


 


4.4         Competition
Filings. 


 


4.4.1         Each
of Buyer and Seller (or, if applicable, their respective ultimate parent entities) shall file or cause to be filed as soon as practicable
but in any event no later than 30 calendar days following the Effective Date, all filings required under the HSR Act in
respect of the transactions contemplated hereby and, if required pursuant to applicable Law, any notifications required under any
other applicable Competition Laws. In connection with such filings, each of Buyer and Seller hereby agree to expressly request
early termination of all applicable waiting periods required under the HSR Act and any other applicable Competition Law. Thereafter,
each of Buyer and Seller shall use commercially reasonable efforts to respond in good faith as promptly as practicable to any inquiries
or requests received from any Governmental Authority for additional information or documentation and to request and cause the approval
waiting periods under applicable Competition Laws to terminate or expire at the earliest possible date after the date of filing.
Buyer and Seller shall notify the other promptly upon the receipt of (a) any comments or communication it or any of its Affiliates
receives from any officials of any Governmental Authority in connection with any filings made pursuant to this Section 4.4.1 and
(b) any request by any officials of any such Governmental Authority for amendments or supplements to any filings made pursuant
to, or information provided to comply in all material respects with, any applicable Law. Buyer and Seller shall permit the other
to review in advance any proposed communication by such Party to any Governmental Authority with respect to any filings made pursuant
to this Section 4.4.1. Whenever any event occurs that is required to be set forth in an amendment or supplement to any filing made
pursuant to this Section 4.4.1, Buyer or Seller, as the case may be, will promptly inform the other of such occurrence and cooperate
in filing with the applicable Governmental Authority such amendment or supplement. Neither Buyer, on the one hand, nor Seller,
on the other hand, shall (or permit any of their respective Affiliates to) agree to participate in any meeting or other discussion
with any Governmental Authority in respect of any filings, investigation (including any settlement of the investigation, Litigation
or other inquiry) relating to this Section 4.4 unless it consults with the other in advance and, to the extent permitted by such
Governmental Authority, gives the other the opportunity to attend and participate at such meeting or other discussion.


 




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4.4.2         In
connection with the filings under Section 4.4.1, Buyer and Seller shall cooperate with each other in good faith and shall (a) promptly
prepare and file all necessary documentation and (b) effect all necessary applications, notices, petitions and filings and
execute all agreements and documents. In connection with the foregoing, Buyer shall have the right to review and reasonably approve
in advance all characterizations of the information relating to Buyer and its Affiliates; Seller shall have the right to review
and reasonably approve in advance all characterizations of the information relating to Seller and its Affiliates; and each of Buyer
and Seller shall have the right to review and reasonably approve in advance all characterizations of the information relating to
the transactions contemplated hereby, in each case, that appear in any material filing made in connection with this Section 4.4.
Each Party may, as it deems advisable or necessary, designate any competitively sensitive materials provided to the other Party
under this Section 4.4 as “outside counsel only.” Any materials so designated may be provided to the other Party’s
outside legal counsel but shall not be provided to the other Party without the prior written consent of the Party providing such
materials.


 


4.4.3         All
filing fees under applicable Competition Laws, and all reasonable out-of-pocket expenses (other than legal fees and expenses, which
shall be borne by the Party incurring such expenses) incurred in complying with any request for additional information or documentary
material from any applicable Governmental Authority, including any necessary merger notifications and investigations, shall be
borne by Buyer.


 


4.4.4         Neither
Seller nor Buyer shall, and each shall cause its respective Affiliates not to, enter into any transaction or any Contract, whether
oral or written, to effect any transaction (including any merger or acquisition) that would reasonably be expected to make it more
difficult, or to increase the time required, to: (a) obtain the expiration or early termination of the waiting period under the
HSR Act (or obtain clearance or approval under applicable foreign Competition Law) applicable to the transactions contemplated
by this Agreement, (b) avoid the entry of, the commencement of Litigation seeking the entry of, or to effect the dissolution of,
any injunction, temporary restraining order or other order that would materially delay or prevent the consummation of the transactions
contemplated hereby or (c) obtain all authorizations, consents, orders and approvals of Governmental Authorities necessary for
the consummation of the transactions contemplated by this Agreement. 


 




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ADDITIONAL COVENANTS
AND AGREEMENTS


 


5.1         Further
Assurances. Each of Seller and Buyer shall, at any time or from time to time after the Closing, at the request and expense
of the other, execute and deliver to the other all such instruments and documents or further assurances as the other may reasonably
request in order to (a) vest in Buyer all of Seller’s right, title and interest in and to the Purchased Assets as contemplated
hereby, (b) effectuate Buyer’s assumption of the Assumed Liabilities and (c) grant to each Party all rights contemplated
herein to be granted to such Party under the Ancillary Agreements; provided, however, that after the Closing, apart
from such customary further assurances, neither Seller nor Buyer shall have any other obligations except as specifically set forth
and described herein or in the Ancillary Agreements. Without limitation of the foregoing, neither Seller nor Buyer shall have any
obligation to assist or otherwise participate in the amendment or supplementation of the Purchased Regulatory Approvals or otherwise
to participate in any filings or other activities relating to the Purchased Regulatory Approvals other than as necessary to effect
the assignment thereof to Buyer in connection with the Closing pursuant to this Agreement.


 


5.2         Publicity.
No public announcement related to this Agreement or the transactions contemplated herein will be issued without the joint written
approval of Seller and Buyer, which approval shall not be unreasonably withheld, conditioned or delayed, except in any public disclosure
which either Seller or Buyer, in its good faith judgment, believes is required by applicable Law or by any stock exchange on which
its securities or those of its Affiliates are listed. If either Party, in its good faith judgment, believes such disclosure is
required, such Party shall use its commercially reasonable efforts to (or in the case of any press release issued, or report filed
with the U.S. Securities and Exchange Commission, in connection with the execution of this Agreement or any version of this Agreement
or any Ancillary Agreement filed with the U.S. Securities and Exchange Commission, shall) consult with the other Party and its
Representatives, and consider in good faith any revisions timely proposed by the other Party or its Representatives, as applicable,
prior to making (or prior to any of its Affiliates making) such disclosure, and shall limit such disclosure to only that information
which is legally required to be disclosed. Notwithstanding the foregoing, Buyer, on the one hand, and Seller, on the other hand,
may make public announcements that are consistent with prior public communications made in compliance with this Section 5.2.


 




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5.3         Confidentiality.


 


5.3.1         All
Confidential Information provided by one Party (or its Representatives or Affiliates) (collectively, the “Disclosing Party”)
to the other Party (or its Representatives or Affiliates) (collectively, the “Receiving Party”) shall be subject
to and treated in accordance with the terms of this Section 5.3. As used in this Section 5.3, “Confidential Information”
means (a) all information disclosed to the Receiving Party by the Disclosing Party in connection with this Agreement or any
Ancillary Agreement, including all information with respect to the Disclosing Party’s licensors, licensees, sublicensees
or Affiliates, (b) all information disclosed to the Receiving Party by the Disclosing Party under the Confidentiality Agreement
and (c) all memoranda, notes, analyses, compilations, studies and other materials prepared by or for the Receiving Party to
the extent containing or reflecting the information in the preceding clause (a) or (b). Confidential Information shall include
the Estimated Monthly Net Sales Reports, Monthly Net Sales Reports, Quarterly Net Sales Reports, Annual Net Sales Reports and Net
Sales Forecasts delivered pursuant to Section 2.3.4 (the “Confidential Net Sales Information”). Notwithstanding
the foregoing, Confidential Information shall not include information that, in each case as demonstrated by competent written documentation:


 


(i)        was
already known to the Receiving Party other than under an obligation of confidentiality, at the time of disclosure by the Disclosing
Party;


 


(ii)       was
generally available to the public or otherwise part of the public domain at the time of its disclosure to the Receiving Party;


 


(iii)        became
generally available to the public or otherwise part of the public domain after its disclosure to the Receiving Party other than
through any act or omission of the Receiving Party in breach of this Agreement or the Confidentiality Agreement;


 


(iv)        is
subsequently disclosed to the Receiving Party by a Third Party without obligations of confidentiality with respect thereto; or


 


(v)       is
subsequently independently discovered or developed by the Receiving Party without the aid, application or use of Confidential Information.


 


5.3.2         All
Confidential Information (a) obtained by Seller (or its Affiliates or Representatives) from Buyer (or its Affiliates or Representatives)
and (b) effective as of the Closing Date, relating solely to the Products, the Purchased Assets and the Assumed Liabilities (the
“Buyer Confidential Information”) shall be deemed to be Confidential Information disclosed by Buyer to Seller
for purposes of this Section 5.3 and shall be used by Seller and its Affiliates solely as required to (i) perform its or their
obligations or exercise or enforce its or their rights under this Agreement or any Ancillary Agreement, (ii) with respect to the
Confidential Net Sales Information, prepare internal reports, forecasts and related financial statements and prepare the consolidated
financial statements of Seller and its Affiliates, in each case, in the ordinary course of business or (iii) comply with applicable
Law (each of (i) through (iii), a “Seller Permitted Purpose”), and for no other purpose. For a period of 10
years after the Effective Date, Seller shall not disclose, or permit the disclosure of, any of the Buyer Confidential Information
to any Person except those Persons to whom such disclosure is necessary in connection with any Seller Permitted Purpose. Seller
shall treat, and shall cause its Affiliates and the Representatives of Seller or any of its Affiliates to treat, the Buyer Confidential
Information as confidential, using the same degree of care as Seller normally employs to safeguard its own confidential information
from unauthorized use or disclosure, but in no event less than a reasonable degree of care.


 




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5.3.3         All
Confidential Information obtained by Buyer (or its Affiliates or Representatives) from Seller (or its Affiliates or Representatives)
other than the Buyer Confidential Information (the “Seller Confidential Information”) shall be used by Buyer
and its Affiliates solely as required to (a) perform its or their obligations or exercise or enforce its or their rights under
this Agreement or any Ancillary Agreement or (b) comply with applicable Law (each of (a) and (b), a “Buyer Permitted Purpose”),
and for no other purpose. For a period of 10 years after the Effective Date, Buyer shall not disclose, or permit the disclosure
of, any of the Seller Confidential Information to any Person except those Persons to whom such disclosure is necessary in connection
with a Buyer Permitted Purpose. Buyer shall treat, and will cause its Affiliates and the Representatives of Buyer or any of its
Affiliates to treat, Seller Confidential Information as confidential, using the same degree of care as Buyer normally employs to
safeguard its own confidential information from unauthorized use or disclosure, but in no event less than a reasonable degree of
care. Notwithstanding the foregoing, Buyer shall, and shall cause its Affiliates, Representatives, transferees and permitted Sublicensees
to, maintain the confidentiality of and protect the Trade Secrets included in the Licensed Manufacturing Technology for such period
of time in excess of 10 years after the Effective Date that such Trade Secrets constitute trade secrets under applicable Law.


 


5.3.4         In
the event either Party is requested pursuant to, or required by, applicable Law to disclose any of the other Party’s Confidential
Information (i.e., Seller Confidential Information or Buyer Confidential Information, as applicable), it will notify the
other Party in a timely manner so that such Party may seek a protective order or other appropriate remedy or, in such Party’s
sole discretion, waive compliance with the confidentiality provisions of this Agreement. Each Party will cooperate in all reasonable
respects in connection with any reasonable actions to be taken for the foregoing purpose. In any event, the Party requested or
required to disclose such Confidential Information may furnish it as requested or required pursuant to applicable Law (subject
to any such protective order or other appropriate remedy) without liability hereunder, provided that such Party furnishes
only that portion of the Confidential Information which such Party is advised by an opinion of its counsel is legally required,
and such Party exercises reasonable efforts to obtain reliable assurances that confidential treatment will be accorded such Confidential
Information.


 


5.3.5         Nothing
in this Section 5.3 shall be construed as preventing or in any way inhibiting either Party from complying with applicable Law governing
activities and obligations undertaken pursuant to this Agreement or any Ancillary Agreement in any manner which it reasonably deems
appropriate.


 


5.4         FDA
Letters. Buyer and Seller shall file the Buyer FDA Transfer Letters and the Seller FDA Transfer Letters, respectively, with
the FDA within five Business Days after the Closing Date. Transfer of title to the Purchased Regulatory Approvals shall be effective
as of the Closing.


 


5.5         Regulatory
Responsibilities. Except as required by a Party to comply with applicable Law or to exercise its rights and obligations hereunder
or under any Ancillary Agreement, Buyer, from and after the date on which the Buyer FDA Transfer Letters and Seller FDA Transfer
Letters are filed with the FDA (the “FDA Transfer Date”), shall have the sole right and responsibility for preparing,
obtaining and maintaining the Purchased Regulatory Approvals, and for conducting communications with Governmental Authorities of
competent jurisdiction, for the Products. Seller shall retain such rights and responsibilities during the period prior to the FDA
Transfer Date.


 




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5.6         Pharmacovigilance.


 


5.6.1         Legacy
Safety Data.  As soon as reasonably practicable following the Closing Date, and solely to the extent in Seller’s
possession or under its control, Seller shall provide to Buyer, in the form of an electronic copy of the CIOMS I form, a copy of
all legacy data of adverse events with respect to the Products, both serious and non-serious, as are necessary for Buyer to hold
the global safety database for the Products (the “Global Safety Database”).


 


5.6.2         Transfer
of Global Safety Database. Seller shall transfer the Global Safety Database to Buyer as soon as reasonably practicable following
Seller’s receipt of written notice from Buyer that Buyer is ready to accept such transfer; provided, that Buyer shall
accept such transfer no later than the date that is 30 calendar days after the FDA Transfer Date. Following such transfer, Buyer
shall maintain the Global Safety Database pursuant to its own policy and standard operating procedures.


 


5.6.3         Obligations
Prior to the FDA Transfer Date.  Until the FDA Transfer Date, Seller shall be responsible for reporting adverse event
information received with respect to Products as required by Law.


 


5.6.4         Obligations
Commencing on FDA Transfer Date.  Effective on the FDA Transfer Date, Buyer shall be responsible for reporting of adverse
event information received with respect to the Products as required by Law.  If Seller receives any adverse event information
with respect to the Products following the Closing, Seller shall provide to Buyer any source documents concerning such adverse
event information within one Business Day following receipt, but in any event, not longer than three calendar days after receipt.


 


5.7         Certain
Tax Matters. 


 


5.7.1         Withholding
Taxes. If applicable Laws require withholding of Taxes imposed upon any payments made by Buyer to Seller pursuant to this Agreement,
Buyer shall make such withholding payments as may be required and shall subtract such withholding payments from such payments.
To the extent such amounts are so deducted or withheld, such amounts will be treated for all purposes under this Agreement as having
been paid to Seller. Buyer shall submit appropriate proof of payment of the withholding Taxes to Seller within a reasonable period
of time.


 




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5.7.2         Transfer
Taxes. All amounts payable hereunder or under any Ancillary Agreement are exclusive of all recordation, transfer, documentary,
excise, sales, value added, use, stamp, conveyance or other similar Taxes, duties or governmental charges, and all recording or
filing fees or similar costs, imposed or levied by reason of, in connection with or attributable to this Agreement and the Ancillary
Agreements or the transactions contemplated hereby and thereby (collectively, “Transfer Taxes”). Buyer shall
be solely responsible for the payment of all Transfer Taxes. Buyer shall pay all amounts due and owing in respect of any Transfer
Taxes, or upon receipt of invoice from Seller shall reimburse Seller for the Transfer Taxes in addition to the sums otherwise payable,
at the rate in force at the due time for payment or such other time as is stipulated under applicable Law. All applicable filings,
reports and returns shall be filed, as provided by applicable Law.


 


5.7.3         Cooperation
and Exchange of Information. Each of Seller and Buyer shall (a) provide the other with such assistance as may reasonably
be requested by the other in connection with the preparation of any Tax Return, audit or other examination by any taxing authority
or judicial or administrative proceeding relating to Liability for Taxes in connection with the Purchased Assets, (b) retain
and provide the other with any records or other information that may be relevant to such Tax Return, audit or examination, proceeding
or determination and (c) inform the other of any final determination of any such audit or examination, proceeding or determination
that affects any amount required to be shown on any Tax Return of the other for any period.


 


5.7.4         Survival
of Covenants. The covenants contained in this Section 5.7 shall survive until 30 calendar days after the expiration of the
applicable statute of limitations (including extensions thereof).


 


5.8         Insurance.
As of the Closing Date, Buyer shall have and maintain adequate insurance coverage, including: (a) products liability coverage
and comprehensive general liability insurance of not less than [***] prior to the First Commercial Sale of any Subject Product;
and (b) any other insurance, including workers’ compensation, cyber liability and professional liability, necessary to cover
its obligations under this Agreement and that are consistent with normal business practices of prudent companies similarly situated.
Such policies shall be blanket policies and shall insure against Liabilities on the part of Buyer and its Affiliates, as their
interests may appear, due to injury, disability or death of any person or persons, or injury to property, arising from the Exploitation
of the Subject Product. Such policies maintained by Buyer shall name Seller and its Affiliates as additional insureds. All insurers
providing such policies shall have an AM Best (A-) or higher rating. Buyer shall provide Seller with certificates of insurance
evidencing that the policies required to be maintained by Buyer hereunder are in full force and effect annually and, upon Seller’s
request, copies of such policies shall be provided. Should any of the policies be cancelled, terminated or otherwise materially
altered before the expiration date thereof, notice will be delivered in accordance with the policy provisions in writing to Seller.
Buyer’s insurers shall waive all rights of subrogation against Seller, its Affiliates and its and their officers, directors
and employees. Buyer’s insurance shall be primary with no contribution by Seller’s insurance. On or prior to the Closing
Date, Buyer shall deliver to Seller an insurer or insurer’s agent’s signed Certificate of Insurance in customary form,
evidencing that Buyer has obtained the foregoing insurance policies, with the insurers, coverages and limits of insurance as are
specified in this Section 5.8, and that such policies are in full force and effect.


 




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5.9         FCPA.



 


5.9.1         In
performing its obligations hereunder, Buyer acknowledges that the corporate policy of Seller requires that Seller’s business
must be conducted within the letter and spirit of all applicable Laws, including the Foreign Corrupt Practices Act (the “FCPA”),
and is applied worldwide. Buyer agrees to conduct, and to cause each of its Affiliates and its and their respective Representatives,
distributors and Sublicensees, to conduct, the activities contemplated herein and in each Ancillary Agreement with respect to the
Subject Products and the Licensed Manufacturing Technology, in a manner which is consistent with all applicable Laws, including
the FCPA.


 


5.9.2         Without
limitation of Section 5.9.1, Buyer represents and warrants that, to its knowledge, as of the date hereof, none of its or its Affiliates’
officers, directors, employees or agents are officials, officers, agents, or representatives of any Governmental Authority having
authority to make or participate in any decisions regarding any Purchased Regulatory Approvals and any pricing or reimbursement
with respect to the Subject Products. Buyer further covenants that neither it nor any of its Affiliates or its or their respective
officers, directors, employees or agents shall make any payment, either directly or indirectly, of money or other assets, including
any compensation derived from this Agreement or any Ancillary Agreement (collectively, a “Payment”), to government
or political party officials, officials of international public organizations, candidates for public office, or representatives
of other businesses or Persons acting on behalf of any of the foregoing (collectively, “Officials”) where such
Payment would constitute a violation of any applicable Law, including the FCPA. In addition, regardless of legality, Buyer shall
not, and shall cause its Affiliates and its and their respective officers, directors, employees and agents not to, make any Payment,
either directly or indirectly, to Officials if such Payment is for the purpose of influencing decisions or actions with respect
to the subject matter of this Agreement or any Ancillary Agreement.


 


5.9.3         Buyer
acknowledges that no employee of Seller or its Affiliates has authority to give any direction, either written or oral, relating
to the making of any commitment by Buyer or its agents to any Third Party in violation of the terms of this Section 5.9.


 


5.9.4         Buyer
shall not use (and shall cause its Affiliates not to use) any Person (including any employee, officer, director, Sublicensee, or
Third Party contractor or distributor) who is (or has been) on the Exclusions List of the Office of Inspector General, U.S. Department
of Health & Human Services, or who is (or has been) in violation of the terms of this Section 5.9 in connection with the performance
of any activities hereunder. Buyer certifies to Seller that, as of the Effective Date, Buyer has screened itself, and its officers
and directors (and its Affiliates, Sublicensees and Third Party contractors and distributors and their respective officers and
directors) against the Exclusions List of the Office of Inspector General, U.S. Department of Health & Human Services. Buyer
shall notify Seller in writing promptly of any breach of this Section 5.9.


 




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5.10       Wrong
Pockets. For a period of up to nine months after the Closing Date, if either Buyer or Seller becomes aware that any of the
Purchased Assets has not been transferred to Buyer or that any of the Excluded Assets has been transferred to Buyer, it shall promptly
notify the other and the Parties shall, as soon as reasonably practicable, ensure that such property is transferred, with any necessary
prior Third Party Consent, to (a) Buyer, in the case of any Purchased Asset which was not transferred to Buyer at the Closing;
or (b) Seller, in the case of any Excluded Asset which was transferred to Buyer at the Closing.


 


5.11       Licensed
Manufacturing Technology. 


 


5.11.1       Effective
as of the Closing, upon the terms and subject to the conditions of this Agreement, Seller (on behalf of itself and its Affiliates)
hereby grants to Buyer and its Affiliates, and Buyer (on behalf of itself and its Affiliates) hereby accepts, a non-exclusive,
irrevocable, fully-paid up, royalty-free, perpetual right and license, with the right to grant sublicenses in accordance with Section
5.11.2, to the Licensed Manufacturing Technology solely to the extent necessary to manufacture or have manufactured the Products
worldwide for Exploitation. The right and license granted to Buyer and its Affiliates under this Section 5.11.1 shall be transferable
solely to a transferee, licensee or assignee pursuant to Section 2.3.5.


 


5.11.2       Buyer
shall have the right to grant sublicenses under the license granted in Section 5.11.1 to Third Parties retained by Buyer to provide
manufacturing services to Buyer (each, a “Sublicensee”); provided, however, that all such sublicenses
shall be limited to the sole purpose of providing such manufacturing services to or for the benefit of a Payment Obligor in connection
with the manufacture of the Products (including engaging any contract manufacturing organization); provided, further
that Buyer shall (a) remain jointly and severally liable for the performance or non-performance of any such Sublicensee and (b)
provide to Seller a written notice setting forth in reasonable detail the nature of such sublicense and the identity of the Sublicensee,
which written notice shall include a copy of any such proposed sublicense agreement. A copy of any sublicense agreement executed
by Buyer pursuant to this Section 5.11.2 (provided that the financial terms of any such sublicense agreement may be redacted
to the extent not pertinent to an understanding of either Party's obligations or benefits under this Agreement) shall be provided
to Seller within 14 calendar days after its execution by the parties thereto. Buyer hereby guarantees the performance of its Affiliates
and permitted Sublicensees and acknowledges that the grant of any such sublicense shall not relieve Buyer of its obligations under
this Agreement.


 


5.11.3       Notwithstanding
anything to the contrary in this Section 5.11, Seller retains sole ownership of and title to the Licensed Manufacturing Technology
and no ownership interest in or title to the Licensed Manufacturing Technology is or was transferred or conveyed to Buyer or any
other Person by this Agreement; provided, however, that any sale of the Licensed Manufacturing Technology by Seller
shall be made subject to the rights of the Buyer hereunder. Buyer acknowledges and agrees that Buyer shall not at any time claim
adversely to Seller or any of its Affiliates any right, title or interest in or to the Licensed Manufacturing Technology, except
as provided in this Section 4.11.


 




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CONDITIONS PRECEDENT


 


6.1         Conditions
to Obligations of Buyer and Seller. The obligations of Buyer and Seller to complete the transactions contemplated by this Agreement
are subject to the satisfaction at or prior to the Closing of the following conditions:


 


6.1.1         No
Adverse Law; No Injunction. No Law shall have been enacted, entered, promulgated or enforced by any Governmental Authority
that prohibits the consummation of all or any material part of the transactions contemplated by this Agreement, and no order by
any Governmental Authority restraining, enjoining or otherwise preventing the consummation of the transactions contemplated hereby
shall be in effect; and


 


6.1.2         Governmental
Approvals. Any applicable waiting period under the HSR Act and any other applicable Competition Law shall have expired or been
terminated.


 


6.2         Conditions
to Obligations of Buyer. The obligation of Buyer to complete the transactions contemplated by this Agreement is subject to
the satisfaction or waiver by Buyer at or prior to the Closing of the following additional conditions:


 


6.2.1         Representations
and Warranties. The representations and warranties of Seller contained in (a) Section 3.1.1, Section 3.1.2, Section 3.1.5 and
Section 3.1.8 shall be true and correct in all but any de minimis respects at and as of the Closing Date as if made at and
as of such date (except that those representations and warranties that address matters only as of a particular date need only be
true and correct in all but any de minimis respects as of such date); (b) Section 3.1.3 and Section 3.1.6 shall be true
and correct (i) in all respects (in the case of any representation or warranty in Section 3.1.3 or Section 3.1.6 that is qualified
by materiality or Material Adverse Effect) at and as of the Closing Date as if made at and as of such date (except that those representations
and warranties that address matters only as of a particular date need only be true and correct as of such date) or (ii) in all
material respects (in the case of any representation or warranty in Section 3.1.3 or Section 3.1.6 that is not qualified by materiality
or Material Adverse Effect) at and as of the Closing Date as if made at and as of such date (except that those representations
and warranties that address matters only as of a particular date need only be true and correct in all material respects as of such
date); and (c) Section 3.1.4 and Section 3.1.7 shall be true and correct in all respects (disregarding any materiality or Material
Adverse Effect qualifiers therein) at and as of the Closing Date as if made at and as of such date (except that those representations
and warranties that address matters only as of a particular date need only be true and correct as of such date), in the case of
this clause (c), except for breaches of such representations and warranties that would not, individually or in the aggregate, have
a Material Adverse Effect;


 


6.2.2         Covenants.
Seller shall have performed and complied in all material respects with all covenants, agreements and obligations required to be
performed or complied with on or prior to the Closing Date; and


 




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6.2.3         Closing
Deliveries. Seller shall have delivered to Buyer each of the items listed in Section 2.4.2(a).


 


6.3         Conditions
to Obligations of Seller. The obligation of Seller to complete the transactions contemplated by this Agreement is subject to
the satisfaction or waiver by Seller at or prior to the Closing of the following additional conditions:


 


6.3.1         Representations
and Warranties. The representations and warranties of Buyer contained in (a) Section 3.3.1, Section 3.3.2, Section 3.3.5 and
Section 3.3.6 shall be true and correct in all but any de minimis respects at and as of the Closing Date as if made at and
as of such date (except that those representations and warranties that address matters only as of a particular date need only be
true and correct in all but any de minimis respects as of such date); (b) Section 3.3.3 shall be true and correct in all
material respects at and as of the Closing Date as if made at and as of such date (except that those representations and warranties
that address matters only as of a particular date need only be true and correct in all material respects as of such date); and
(c) Section 3.3.4 shall be true and correct in all respects (disregarding any materiality or Buyer Material Adverse Effect qualifiers
therein) at and as of the Closing Date as if made at and as of such date (except that those representations and warranties that
address matters only as of a particular date need only be true and correct as of such date), in the case of this clause (c), except
for breaches of such representations and warranties that would not, individually or in the aggregate, have a Buyer Material Adverse
Effect;


 


6.3.2         Covenants.
Buyer shall have performed and complied in all material respects with all covenants, agreements and obligations required to be
performed or complied with on or prior to the Closing Date; and


 


6.3.3         Closing
Deliveries. Buyer shall have delivered to Seller each of the items listed in Section 2.4.2(b) and Seller shall have received
the Closing Payment.


 


6.4         Frustration
of Closing Conditions. With respect to the conditions to Buyer’s and Seller’s respective obligations to consummate
the transactions contemplated by this Agreement as provided hereunder and each Party’s right to terminate this Agreement
as provided in Article 8, neither Buyer nor Seller may rely on the failure of any condition set forth in this Article 6 to be satisfied
if such failure was caused by such Party’s failure to act in good faith or to use its reasonable best efforts to cause the
condition to be satisfied to the extent required by Section 4.3.


 


INDEMNIFICATION


 


7.1         Indemnification.


 


7.1.1         Indemnification
by Seller. Following the Closing, but subject to the provisions of this Article 7, Seller shall indemnify, defend and hold
harmless Buyer and its Affiliates, and its and their respective officers, directors, employees and agents (collectively, “Buyer
Indemnitees”) from and against, and compensate or reimburse the Buyer Indemnitees for, any and all Losses incurred by
any Buyer Indemnitee arising out of or related to:


 




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(a)        any
breach by Seller of any of the representations or warranties made by Seller in Section 3.1;


 


(b)        any
failure of Seller to perform or any breach by Seller of any of its covenants, agreements or obligations contained in this Agreement;
or


 


(c)        any
Excluded Liability.


 


7.1.2         Indemnification
by Buyer. Following the Closing, but subject to the provisions of this Article 7, Buyer shall indemnify and hold harmless Seller
and its Affiliates, and their respective licensors, licensees, officers, directors, employees and agents (collectively, “Seller
Indemnitees”) from and against, and compensate or reimburse the Seller Indemnitees for, any and all Losses incurred by
any Seller Indemnitee arising out of or related to:


 


(a)        any
breach by Buyer of any of the representations or warranties made by Buyer in this Agreement;


 


(b)        any
failure of Buyer to perform or any breach by Buyer of any of its covenants, agreements or obligations contained in this Agreement;
or


 


(c)        any
Assumed Liability (except to the extent Seller is required to indemnify any Buyer Indemnitee for such Losses pursuant to Section
7.1.1(a)).


 


7.2         Claim
Procedure.


 


7.2.1         Indemnification
Claim Procedure. Except as provided in Section 7.2.2 with respect to Third Party claims, in the event of a claim made by a
Buyer Indemnitee or a Seller Indemnitee (the “Indemnified Party”), the Indemnified Party shall give reasonably
prompt written notice to the other Party (the “Indemnifying Party”), which notice (an “Indemnification
Certificate”) shall: (a) state that the Indemnified Party has paid or properly accrued or reasonably anticipates
that it will have to pay or accrue Losses that are subject to indemnification by the Indemnifying Party pursuant to Section 7.1.1
or Section 7.1.2, as applicable, and (b) specify in reasonable detail the individual items and amounts of such Losses, the
date each such item was paid or properly accrued, or the basis for such anticipated Liability, and a description of the basis of
such Indemnified Party’s claim for indemnification; provided, however, that the failure to give reasonably
prompt notice shall not relieve the applicable Indemnifying Party of its indemnification obligations under this Agreement except
to the extent that the Indemnifying Party is materially prejudiced by any delay in receiving such notice. In the event that the
Indemnifying Party agrees to or is determined to have an obligation to reimburse the Indemnified Party for Losses as provided in
this Article 7, the Indemnifying Party shall, subject to the provisions of Section 7.3, promptly (but, in any event, within 30
calendar days) pay such amount to the Indemnified Party by wire transfer of immediately available funds to the account specified
in writing by the Indemnified Party. The Indemnifying Party may defer making such payment if it objects in a written statement
to the claim made in the Indemnification Certificate and delivers such statement to the Indemnifying Party prior to the expiration
of such 30- calendar day period. An Indemnifying Party’s failure to object within such 30- calendar day period to any claim
set forth in an Indemnification Certificate shall be deemed to be the Indemnifying Party’s acceptance of, and waiver of any
objections to, such claim. If an Indemnifying Party shall so object in writing to any claim or claims made in any Indemnification
Certificate, the Indemnifying Party and the Indemnified Party shall attempt in good faith for a period of 20 calendar days following
the Indemnified Party’s receipt of such objection notice to agree upon the respective rights of the parties with respect
to each of such claims. If no such agreement can be reached after such 20- calendar day period of good faith negotiation, either
the Indemnifying Party or the Indemnified Party may initiate Litigation for purposes of having the matter settled in accordance
with the terms of this Agreement.


 




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7.2.2         Third
Party Claim Procedure. In the event an Indemnified Party becomes aware of a claim made by a Third Party (including any action
or proceeding commenced or threatened to be commenced by any Third Party) that such Indemnified Party reasonably believes may result
in an indemnification claim pursuant to Section 7.1, such Indemnified Party shall promptly (and in any event within three Business
Days after becoming aware of such claim) notify the Indemnifying Party in writing of such claim (such notice, the “Claim
Notice”). The Claim Notice shall be accompanied by reasonable supporting documentation submitted by the Third Party making
such claim and shall describe in reasonable detail (to the extent known by the Indemnified Party) the facts constituting the basis
for such claim and the amount of the claimed damages; provided, however, that no delay or failure on the part of
the Indemnified Party in delivering a Claim Notice shall relieve the Indemnifying Party from any Liability hereunder except to
the extent of any damage or Liability caused by or arising out of such delay or failure. Within 30 calendar days after receipt
of any Claim Notice, the Indemnifying Party may, upon written notice thereof to the Indemnified Party, assume control of the defense
of the claim referred to therein at the Indemnifying Party’s sole cost and expense (which shall be subject to Section 7.3)
with counsel reasonably satisfactory to the Indemnified Party. If the Indemnifying Party does not so assume control of the defense
of such claim, the Indemnified Party shall control the defense of such claim. The Party not controlling the defense of such claim
(the “Non-Controlling Party”) may participate therein at its own expense; provided, however, that
if the Indemnifying Party assumes control of the defense of such claim and the Indemnifying Party and the Indemnified Party have
materially conflicting interests or different defenses available with respect to such claim that cause the Indemnified Party to
hire its own separate counsel with respect to such proceeding, the reasonable fees and expenses of a single counsel to the Indemnified
Party shall be considered “Losses” for purposes of this Agreement. The Party controlling the defense of such claim
(the “Controlling Party”) shall keep the Non-Controlling Party reasonably advised of the status of such claim
and the defense thereof and shall consider in good faith recommendations made by the Non-Controlling Party with respect thereto.
The Non-Controlling Party shall furnish the Controlling Party with such information as it may have with respect to such claim (including
copies of any summons, complaint or other pleading that may have been served on such party and any written claim, demand, invoice,
billing or other document evidencing or asserting the same) and shall otherwise cooperate with and assist the Controlling Party
in the defense of such claim. Neither the Indemnified Party nor the Indemnifying Party shall agree to any settlement of, or the
entry of any judgment arising from, any such claim without the prior written consent of the other Party, which consent shall not
be unreasonably withheld, conditioned or delayed; provided, however, that the consent of the Indemnified Party shall
not be required with respect to any such settlement or judgment if the Indemnifying Party agrees in writing to pay or cause to
be paid any amounts payable pursuant to such settlement or judgment (net of the applicable deductible amount specified in Section
7.3.1) and such settlement or judgment includes no admission of liability by or other obligation on the part of the Indemnified
Party and includes a complete release of the Indemnified Party from further Liability.


 




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7.3         Limitations
on Indemnification.


 


7.3.1         The
provisions for indemnity under Section 7.1.1(a) or Section 7.1.2(a) shall be effective only (a) for any individual claim or
series of related claims arising from the same facts and circumstances where the Loss exceeds [***] and (b) when the aggregate
amount of all Losses for claims or series of related claims arising from the same facts and circumstances in excess of [***] for
which indemnification is sought from the Indemnifying Party exceeds [***], in which case the Indemnified Party shall be entitled
to indemnification of the Indemnified Party’s Losses in excess thereof. In no event shall any Indemnifying Party have liability
for indemnification under Section 7.1.1(a) or Section 7.1.2(a), as applicable, for any amount exceeding, in the aggregate, [***].


 


7.3.2         The
Indemnified Party shall take all commercially reasonable steps to mitigate any Losses incurred by such Party upon and after becoming
aware of any event or condition that would reasonably be expected to give rise to any indemnification rights hereunder. The amount
of Losses recovered by an Indemnified Party under Section 7.1.1 or Section 7.1.2, as applicable, shall be reduced by (a) any
amounts actually recovered by the Indemnified Party from a Third Party in connection with such claim and (b) the amount of
any insurance proceeds paid to the Indemnified Party relating to such claim, in each case ((a) and (b)), out of the Indemnified
Party’s costs of recovery. Buyer shall use its reasonable best efforts to collect insurance proceeds for any Loss that is
subject to indemnification by Seller under Section 7.1.1. If any amounts referenced in the preceding clauses (a) and (b) are received
after payment by the Indemnifying Party of the full amount otherwise required to be paid to an Indemnified Party pursuant to this
Article 7, the Indemnified Party shall repay to the Indemnifying Party, promptly after such receipt, any amount that the Indemnifying
Party would not have had to pay pursuant to this Article 7 had such amounts been received prior to such payment.


 


7.3.3         If
the Indemnified Party receives any payment from an Indemnifying Party in respect of any Losses pursuant to Section 7.1.1 or Section
7.1.2 and the Indemnified Party could have recovered all or a part of such Losses from a Third Party based on the underlying claim
asserted against the Indemnifying Party, the Indemnified Party shall assign such of its rights to proceed against such Third Party
as are necessary to permit the Indemnifying Party to recover from the Third Party the amount of such payment.


 




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7.3.4         The
representations and warranties of Seller and Buyer contained in this Agreement shall survive the Closing and continue in full force
and effect thereafter through and including the date that is [***] after the Closing Date. None of the covenants or agreements
contained in this Agreement shall survive the Closing other than those that by their terms expressly contemplate performance after
the Closing Date and such surviving covenants and agreements shall survive the Closing until fully performed.


 


7.3.5         TO
THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW AND EXCEPT AS A RESULT OF COMMON LAW FRAUD, NEITHER BUYER NOR SELLER SHALL BE LIABLE
TO THE OTHER, OR THEIR AFFILIATES, FOR ANY CLAIMS, DEMANDS OR SUITS FOR CONSEQUENTIAL, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE,
INDIRECT OR MULTIPLE DAMAGES, INCLUDING LOSS OF PROFITS, REVENUE OR INCOME, DIMINUTION IN VALUE OR LOSS OF BUSINESS OPPORTUNITY
(WHETHER OR NOT FORESEEABLE AT THE EFFECTIVE DATE), CONNECTED WITH OR RESULTING FROM ANY BREACH OF THIS AGREEMENT, OR ANY ACTIONS
UNDERTAKEN IN CONNECTION HEREWITH, OR RELATED HERETO, INCLUDING ANY SUCH DAMAGES WHICH ARE BASED UPON BREACH OF CONTRACT, TORT
(INCLUDING NEGLIGENCE AND MISREPRESENTATION), BREACH OF WARRANTY, STRICT LIABILITY, STATUTE, OPERATION OF LAW OR ANY OTHER THEORY
OF RECOVERY.


 


7.3.6         For
the avoidance of doubt, no Indemnitee shall be entitled to indemnification under this Article 7 in respect of any Loss to the extent
such Indemnitee has been previously indemnified or reimbursed in respect of such Loss pursuant to any other provision of this Agreement
or any provision of any Ancillary Agreement.


 


7.4         Tax
Treatment of Indemnification Payments. All payments made pursuant to this Article 7 shall be treated as adjustments to the
Purchase Price for all Tax purposes, unless otherwise required by applicable Law.


 


7.5         Exclusive
Remedy. Except as expressly provided otherwise in this Agreement and subject to Section 9.9, each Party acknowledges and agrees
that, following the Closing, the remedies provided for in this Article 7 shall be the sole and exclusive remedies for claims and
damages available to the Parties and their respective Affiliates arising out of or relating to this Agreement and the transactions
contemplated hereby, except that nothing herein shall limit the Liability of either Party for common law fraud. Notwithstanding
anything to the contrary contained in this Agreement, no breach of any representation, warranty, covenant or agreement contained
herein shall, after the consummation of the transactions contemplated by this Agreement, give rise to any right on the part of
Buyer, on the one hand, or Seller, on the other hand, to rescind this Agreement or any of the transactions contemplated hereby.


 


7.6         Setoff
Rights. Except as provided in Sections 2.3.2(b) and (c) above, neither Party shall have any right of setoff of any amounts
due and payable, or any Liabilities arising, under this Agreement against any other amounts due and payable under this Agreement
or any amounts due and payable, or any Liabilities arising, under any Ancillary Agreement. The payment obligations under each of
this Agreement and the Ancillary Agreements remain independent obligations of each Party, irrespective of any amounts owed to any
other Party under this Agreement or the respective Ancillary Agreements.


 




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7.7         Disclaimer.
Except as expressly set forth in any representation or warranty in Section 3.1, Buyer acknowledges and agrees that it and other
Buyer Indemnitees shall have no claim or right to indemnification pursuant to this Article 7 (or otherwise) with respect to any
information, documents, or materials furnished to or for Buyer or its Representatives by Seller or any of its Affiliates or any
of their Representatives, including any information, documents, or material made available to Buyer in any “data room,”
“teaser,” management presentation or other form in connection with the transactions contemplated by this Agreement
or any Ancillary Agreement.


 


TERMINATION


 


8.1         Termination.
Prior to the Closing, this Agreement shall terminate on the earliest to occur of any of the following events:


 


8.1.1         the
mutual written agreement of Buyer and Seller;


 


8.1.2         by
written notice delivered by either Buyer or Seller to the other, if the Closing shall not have occurred on or prior to [***] (the
“End Date”) (other than (a) due to a breach of any representation or warranty hereunder of the Party seeking
to terminate this Agreement, (b) as a result of the failure on the part of the Party seeking to terminate this Agreement to comply
with or perform any of its covenants, agreements or obligations under this Agreement or (c) as a result of any closing condition
in favor of the non-terminating Party not being satisfied, which closing condition has been waived by the non-terminating Party);
provided, however, that (i) Buyer shall not have the right to terminate this Agreement pursuant to this Section 8.1.2
during the pendency of any Litigation brought prior to the End Date by Seller for specific performance of this Agreement and (ii)
Seller shall not have the right to terminate this Agreement pursuant to this Section 8.1.2 during the pendency of any Litigation
brought before the End Date by Buyer for specific performance of this Agreement;


 


8.1.3         by
written notice delivered by Buyer to Seller, if (a) there has been a breach by Seller of a representation or warranty of Seller
contained in this Agreement or (b) there shall be a material breach by Seller of any covenant, agreement or obligation of
Seller in this Agreement, and such failure or material breach described in clause (a) or (b) would result in the failure of a condition
set forth in Section 6.2.1 or Section 6.2.2 that has not been waived by Buyer, or in the case of a breach of any covenant or agreement,
is not cured upon the earlier to occur of (i) the 30th day after written notice thereof is given by Buyer to Seller and (ii) the
Business Day prior to the End Date; provided, that Buyer may not terminate this Agreement pursuant to this Section 8.1.3
if Buyer is in material breach of its agreements or covenants contained in this Agreement;


 


8.1.4         by
written notice delivered by Seller to Buyer, if (a) there has been a breach by Buyer of a representation or warranty of Buyer
contained in this Agreement or (b) there shall be a material breach by Buyer of any covenant, agreement or obligation of Buyer
in this Agreement, and such failure or breach described in clause (a) or clause (b) would result in the failure of a condition
set forth in Section 6.3.1 or Section 6.3.2 that has not been waived by Seller, or in the case of a breach of any covenant or agreement,
is not cured upon the earlier to occur of (i) the 30th day after written notice thereof is given by Seller to Buyer and (ii) the
Business Day prior to the End Date; provided, that Seller may not terminate this Agreement pursuant to this Section 8.1.4
if Seller is in material breach of its agreements or covenants contained in this Agreement; or


 




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8.1.5         by
written notice delivered by Seller to Buyer or by Buyer to Seller if the condition set forth in Section 6.1.1 cannot be satisfied
prior to the End Date; provided, however, that the right to terminate this Agreement pursuant to this Section 8.1.5
shall not be available to a Party if the inability to satisfy the condition set forth in Section 6.1.1 is a result of the failure
of such Party to perform any of its covenants, agreements or obligations under this Agreement.


 


8.2         Procedure
and Effect of Termination.


 


8.2.1         Notice
of Termination. Termination of this Agreement by either Buyer or Seller shall be by delivery of a written notice to the other.
Such notice shall state the termination provision in this Agreement that such terminating Party is claiming provides a basis for
termination of this Agreement. Termination of this Agreement pursuant to the provisions of Section 8.1 shall be effective upon
and as of the date of delivery of such written notice as determined pursuant to Section 9.2 or such other date as is provided in
Section 8.1 above.


 


8.2.2         Effect
of Termination. In the event of the termination of this Agreement pursuant to Section 8.1 by Buyer or Seller, this Agreement
shall be terminated and have no further effect, and there shall be no liability hereunder on the part of Seller, Buyer or any of
their respective Affiliates, except that Sections 5.2 (Publicity), 5.3 (Confidentiality), 8.2.2 (Effect of Termination),
8.2.3 (Withdrawal of Certain Filings) and Article 9 (Miscellaneous) shall survive any termination of this Agreement.
For clarity, in the event of termination of this Agreement pursuant to Section 8.1, the Parties shall not enter into any of the
Ancillary Agreements or have any obligations thereunder. Nothing in this Section 8.2.2 shall relieve any Party to this Agreement
of liability for common law fraud in connection with, or any breach of, this Agreement prior to the termination hereof.


 


8.2.3         Withdrawal
of Certain Filings. As soon as practicable following a termination of this Agreement for any reason, but in no event more than
30 calendar days after such termination, Buyer or Seller shall, to the extent practicable, withdraw all filings, applications and
other submissions relating to the transactions contemplated by this Agreement filed or submitted by or on behalf of such Party,
any Governmental Authority or other Person.


 


MISCELLANEOUS


 


9.1         Governing
Law, Jurisdiction, Venue and Service.


 


9.1.1         Governing
Law. This Agreement shall be governed by and construed in accordance with the Laws of the State of New York, excluding any
conflicts or choice of Law rule or principle that might otherwise refer construction or interpretation of or any matter in dispute
under this Agreement to the substantive Law of another jurisdiction.


 




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9.1.2         Jurisdiction.
Subject to Section 9.9, the Parties hereby irrevocably and unconditionally consent to the exclusive jurisdiction of the courts
of the State of New York sitting in the Borough of Manhattan and the United States District Court for the Southern District of
New York (the “Applicable Courts”) for any action, suit or proceeding (other than appeals therefrom) arising
out of or relating to this Agreement or the transactions contemplated hereby, and agree not to commence any action, suit or proceeding
(other than appeals therefrom) related thereto except in such courts. Notwithstanding the foregoing, any judgment or order issued
by any Applicable Court may be enforced in any other court or applicable Governmental Authority, and neither Party shall challenge
any such judgment or order in any court other than the Applicable Courts. The Parties irrevocably and unconditionally waive their
right to a jury trial for any action, suit or proceeding arising out of or relating to this Agreement or the transactions contemplated
hereby.


 


9.1.3         Venue.
The Parties further hereby irrevocably and unconditionally waive any objection to the laying of venue of any action, suit or proceeding
(other than appeals therefrom) arising out of or relating to this Agreement or the transactions contemplated hereby in the Applicable
Courts, and hereby further irrevocably and unconditionally waive and agree not to plead or claim in any Applicable Court that any
such action, suit or proceeding brought in any such court has been brought in an inconvenient forum.


 


9.1.4         Service.
Each Party further agrees that service of any process, summons, notice or document by registered mail to its address set forth
in Section 9.2.2 shall be effective service of process for any action, suit or proceeding brought against it under this Agreement
or in connection with the transactions contemplated hereby in any such court.


 


9.2         Notices.


 


9.2.1         Notice
Requirements. Any notice, request, demand, waiver, consent, approval or other communication permitted or required under this
Agreement (each, a “Notice”) shall be in writing, shall refer specifically to this Agreement and shall be deemed
given only if delivered by hand or sent by facsimile transmission (with transmission confirmed) or by internationally recognized
overnight delivery service that maintains records of delivery, addressed to the Parties at their respective addresses specified
in Section 9.2.2 or to such other address as the Party to whom notice is to be given may have provided to the other Party at least
10 calendar days’ prior to such address taking effect in accordance with this Section 9.2. Such Notice shall be deemed to
have been given as of the date delivered by hand or internationally recognized overnight delivery service or confirmed that it
was received by facsimile (with receipt confirmed by telephone or email). Any Notice delivered by facsimile shall be confirmed
by a hard copy delivered as soon as practicable thereafter.


 




     37


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

 


9.2.2       Address
for Notice.


 


If to Seller, to:


 


Merck Sharp & Dohme B.V.


Waarderweg 39


2031 BN


Haarlem


Netherlands


Facsimile: + 31 41 266 2559


Attention: Legal Department


 


with a copy (which shall not constitute notice) to:


 


Merck Sharp & Dohme Corp.


One Merck Drive


Whitehouse Station, NJ 08889


Facsimile: (908) 735-1246


Attention: Office of Secretary


 


and to:


 


Covington & Burling LLP

One CityCenter, 850 Tenth Street, N.W.

Washington, DC 20001

Facsimile: (202) 778-5168


Attention: Michael J. Riella


 


If to Buyer, to:


 


ANI Pharmaceuticals, Inc.

210 Main Street West

Baudette, MN 56623

Attn: Charlotte C. Arnold

Facsimile: 218-634-3540


 


with a copy (which shall not constitute notice) to:


 


Dentons US LLP

1221 Avenue of the America

New York, NY 10020

Attn: Paul A. Gajer

Facsimile: 212-768-6800


 


9.3         No
Benefit to Third Parties. The covenants and agreements set forth in this Agreement are for the sole benefit of the Parties
and their successors and permitted assigns, and, except for the rights of Buyer Indemnitees and Seller Indemnitees under Article
7, they shall not be construed as conferring any rights on any other Persons.


 




     38


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

 


9.4         Waiver
and Non-Exclusion of Remedies. Any term or condition of this Agreement may be waived at any time by the Party that is entitled
to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf
of the Party waiving such term or condition. The waiver by either Party of any right hereunder or of the failure to perform or
of a breach by the other Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by said
other Party whether of a similar nature or otherwise. The rights and remedies provided herein are cumulative and do not exclude
any other right or remedy provided by applicable Law or otherwise available except as expressly set forth herein.


 


9.5         Expenses.
Except as otherwise specified herein, and whether or not the Closing takes place, each Party shall bear any costs and expenses
incurred by it with respect to the transactions contemplated herein.


 


9.6         Assignment.
Neither this Agreement nor Buyer’s rights or obligations hereunder may be assigned or delegated by Buyer without the
prior written consent of Seller, and any attempted assignment or delegation of this Agreement or any of such rights or obligations
by Buyer without the prior written consent of Seller shall be void and of no effect, except that no such consent shall be required
in connection with (a) the sale of all or substantially all of the assets of the Buyer in one or a series of related transactions
or (b) Buyer’s assignment of this Agreement and all of its rights and obligations hereunder to an Affiliate of Buyer during
the Pre-Closing Period; provided, that no assignment by Buyer pursuant to the preceding clause (b) shall relieve Buyer of
any of its obligations hereunder. Seller may assign this Agreement or assign or delegate any of Seller’s rights or obligations
hereunder without the prior written consent of Buyer. Subject to the preceding sentences, this Agreement will be binding upon,
inure to the benefit of, and be enforceable by, the Parties and their respective successors and permitted assigns.  


 


9.7         Amendment.
This Agreement may not be modified, amended, altered or supplemented except upon the execution and delivery of a written agreement
executed by both Parties.


 


9.8         Severability.
If any provision of this Agreement is held to be illegal, invalid or unenforceable under any present or future Law, and if
the rights or obligations of either Party under this Agreement will not be materially and adversely affected thereby, (a) such
provision shall be fully severable, (b) this Agreement shall be construed and enforced as if such illegal, invalid or unenforceable
provision had never comprised a part hereof, (c) the remaining provisions of this Agreement shall remain in full force and
effect and shall not be affected by the illegal, invalid or unenforceable provision or by its severance herefrom and (d) in
lieu of such illegal, invalid or unenforceable provision, there shall be added automatically as a part of this Agreement a legal,
valid and enforceable provision as similar in terms to such illegal, invalid or unenforceable provision as may be possible and
reasonably acceptable to the Parties.


 




     39


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

 


9.9         Equitable
Relief. The Parties agree that irreparable damage would occur in the event that any of the provisions of this Agreement were
not performed in accordance with their specific terms or were otherwise breached. It is accordingly agreed that the Parties shall
be entitled to an injunction or injunctions to prevent breaches of this Agreement and to enforce specifically the terms and provisions
of this Agreement in any court of the United States or any state having jurisdiction, this being in addition to any other remedy
to which they are entitled at law or in equity. Each Party hereby waives (a) any requirement that the other Party post a bond
or other security as a condition for obtaining any such relief, and (b) any defenses in any action for specific performance,
including the defense that a remedy at law would be adequate.


 


9.10       English
Language. This Agreement shall be written and executed in, and all other communications under or in connection with this Agreement
shall be in, the English language. Any translation into any other language shall not be an official version thereof, and in the
event of any conflict in interpretation between the English version and such translation, the English version shall control.


 


9.11       Bulk
Sales Statutes. Buyer hereby waives compliance by Seller with any applicable bulk sales statutes in any jurisdiction in connection
with the transactions under this Agreement.


 


9.12       Counterparts.
This Agreement may be executed in any number of counterparts, and each such counterpart hereof shall be deemed to be an original
instrument, but all such counterparts together shall constitute but one agreement. Delivery of an executed counterpart of a signature
page of this Agreement by facsimile or other electronic transmission shall be effective as delivery of a manually executed original
counterpart of this Agreement.


 


9.13       Entire
Agreement. This Agreement, together with the Schedules and Exhibits expressly contemplated hereby and attached hereto, the
Disclosure Schedules, the Ancillary Agreements and the other agreements, certificates and documents delivered in connection herewith
or therewith or otherwise in connection with the transactions contemplated hereby and thereby, contain the entire agreement between
the Parties with respect to the transactions contemplated hereby or thereby and supersede all prior agreements, understandings,
promises and representations, whether written or oral, between the Parties with respect to the subject matter hereof and thereof,
including the Confidentiality Agreement. In the event of any inconsistency between any such Schedules and Exhibits and this Agreement,
the terms of this Agreement shall govern.


 


[Signature page follows]


 




     40


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

 


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


 


	 	Merck Sharp & Dohme B.V.
	 	 	 
	 	By:	 
	 	 	Name:
	 	 	Title:
	 	 
	 	ANI PHARMACEUTICALS, INC.
	 	 	 
	 	By:	 
	 	 	Name:
	 	 	Title:


 


[Signature Page to Asset Purchase Agreement]


 




     


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

 


Schedule 1.1.34


 


Licensed Manufacturing
Technology


 


[***]


 




     


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

 


Schedule 1.1.46


 


Purchased Documents



 


[***]


 




     


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

 


Schedule 1.1.50


 


Seller’s Knowledge


 


[***]


 




     


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    








 


Schedule 2.3.2(a)






Contingent Payments


 


	[***]
	[***]
	[***]


 




     


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

  


Schedule 4.2



Ordinary Course of Business


 


[***]


 




     


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

  


EXHIBIT
A


 


Bill
of Sale and


Assignment
and Assumption Agreement


 


This Bill of Sale and Assignment and Assumption
Agreement (this “Agreement”) is made as of this [•] day of __________, 2016, by and between Merck Sharp
& Dohme B.V., a limited liability company (a Besloten Vennootschap) organized and existing under the Laws of the Netherlands
(“MSD BV”), Merck Sharp & Dohme Corp., a New Jersey corporation, Organon USA, Inc., a New Jersey corporation
(each, a “Seller”) on the one hand and [ANI Pharmaceuticals, Inc., a Delaware corporation] (“Buyer”)
on the other. Each Seller and Buyer is sometimes referred to herein individually as a “Party” and are referred
to herein collectively as the “Parties.”


 


RECITALS


 


WHEREAS, MSD BV and Buyer have entered
into that certain Asset Purchase Agreement, dated as of September 18, 2015 (the “Asset Purchase Agreement”);
and


 


WHEREAS, pursuant to the Asset Purchase
Agreement, Buyer has agreed to acquire the Purchased Assets and assume the Assumed Liabilities from MSD BV or its Specified Affiliates,
and MSD BV has agreed to sell, transfer, convey, assign and deliver to Buyer all of MSD BV’s or its Specified Affiliates’
rights, title and interest in and to the Purchased Assets and transfer the Assumed Liabilities to Buyer.


 


AGREEMENT


 


NOW, THEREFORE, in consideration
of the mutual benefits to be derived from this Agreement and of the representations, warranties, conditions, agreements and promises
contained in the Asset Purchase Agreement, this Agreement and the other Ancillary Agreements, and other good and valuable consideration,
the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, hereby agree as follows:


 


		1.	Defined Terms. Unless otherwise specifically provided herein, capitalized terms used in this Agreement and not otherwise
defined herein shall have the respective meanings ascribed thereto in the Asset Purchase Agreement.



 


		2.	Conveyance and Acceptance. In accordance with the provisions of the Asset Purchase Agreement, (a) each Seller hereby
sells, transfers, conveys, assigns and delivers to Buyer, free and clear of any Liens other than Permitted Liens, all of its right,
title, and interest in and to the Purchased Assets, and (b) Buyer hereby accepts such sale, transfer, conveyance, assignment and
delivery.



 




     2


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

  


		3.	Assumption of Assumed Liabilities. Each Seller hereby assigns to Buyer the Assumed Liabilities and Buyer hereby unconditionally
assumes and agrees to pay and discharge when due the Assumed Liabilities.



 


		4.	Asset Purchase Agreement Controls. Notwithstanding any other provision of this Agreement to the contrary, nothing contained
herein shall in any way supersede, modify, replace, amend, change, rescind, waive, exceed, expand, enlarge or in any way affect
the provisions, including warranties, covenants, agreements, conditions, representations or, in general any of the rights and remedies,
or any of the obligations of Buyer or MSD BV set forth in the Asset Purchase Agreement. This Agreement is subject to, and governed
entirely in accordance with, the terms and conditions of the Asset Purchase Agreement. Nothing contained herein is intended to
modify or supersede any of the provisions of the Asset Purchase Agreement.



 


		5.	Counterparts. This Agreement may be executed in any number of counterparts, and each such counterpart hereof shall be
deemed to be an original instrument, but all such counterparts together shall constitute but one agreement. Delivery of an executed
counterpart of a signature page of this Agreement by facsimile or other electronic transmission shall be effective as delivery
of a manually executed original counterpart of this Agreement.



 


[Signature page follows]


 




     3


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

 


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


 


	 	Merck Sharp & Dohme B.V.
	 	 	 
	 	By:	      
	 	 	Name:
	 	 	Title:
	 	 	 
	 	Merck Sharp & Dohme CORP.
	 	 	 
	 	By:	 
	 	 	Name:
	 	 	Title:
	 	 	 
	 	Organon USA, Inc.
	 	 	 
	 	By:	 
	 	 	Name:
	 	 	Title:
	 	 	 
	 	[ANI PHARMACEUTICALS, INC.]
	 	 	 
	 	By:	 
	 	 	Name:
	 	 	Title:


 




     


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

  


EXHIBIT B-1


BUYER FDA TRANSFER LETTERS


 


	


 


________ __, 2016


 


	Jean-Marc Guettier, M.D., Director	 
	Division of Metabolism and

Endocrinology Products (DMEP)	Acceptance of 
	Center for Drug Evaluation and Research	of NDA Ownership
	Food and Drug Administration	 
	5901-B Ammendale Road	 
	Beltsville, MD 20705-1266	 


 


	SUBJECT:	
        NDA 08975

        Purified Cortrophin gel (Corticotropin) Injection, 40 Units/mL
        and 80 Units/mL



 


Dear Dr. Guettier:


 


In accordance with 21 CFR § 314.72(a)(2),[
[name of subsidiary], a wholly owned subsidiary of ANI Pharmaceuticals, Inc.], is accepting the transfer of ownership, including
all rights to the New Drug Application (NDA) 08975: Purified Cortrophin gel (Corticotropin) Injection, 40 Units/mL and 80 units/ml
from Merck Sharp & Dohme Corp. (Please refer to Module 1.3.1.5 Change in Ownership of an Application).


 


Merck Sharp & Dohme Corp. (Merck), a subsidiary of Merck
& Co., Inc., notified the agency of the transfer on behalf of Organon, USA Inc., which is also a subsidiary of Merck &
Co., Inc. of this ownership in the Transfer of NDA Ownership letter dated ________ __, 2016. The effective date of the change of
ownership is ________ __, 2016.


 


	New Owner of NDA	 	Previous Owner of NDA
	 	 	 
	[name of subsidiary]	 	 
	210 Main Street West	 	[Merck]
	Baudette, MN 56623	 	 


 






     2


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

 


By accepting the ownership of this NDA
08975, [name of subsidiary] commits to all agreements, promises and conditions made by the former owner (Merck) and contained in
the application. [name of subsidiary] has received a copy of the approved application, including supplements and records that are
required to be kept under 21 CFR § 314.81. If at any time during the review of the transferred records [name of subsidiary].
becomes aware of absent documents that are required, we commit to making a request from the FDA’s files under the fee schedule
in 21 CFR § 20.45 of FDA’s public information regulations.


 


In accordance with 21 CFR § 314.72(b),
[name of subsidiary] will advise the FDA about any change in the conditions in the approved applications under 21 CFR § 314.70.
Additionally, [name of subsidiary] will include in the subsequent annual report any changes to the drug product’s label or
labeling to change the product’s brand or the name of the manufacturer, packer, or distributor.


 


Please note the contact information for
the Responsible official at ANI Pharmaceuticals, Inc. for all regulatory inquiries: (Refer to Module 1.3.1.2 Change in Contact/Agent).


 


	Responsible Official
	Name:	Ellen Camos
	Title:	Director, Regulatory Affairs
	Phone :	919.449.4033
	Alt. Phone:	218.634.3638
	Fax :	888.519.0459
	Email :	ellen.camos@anipharmaceuticals.com


 


The electronic submission is in the Electronic
Common Technical Document format (eCTD) and sent via the FDA Gateway; sequence 0000. The approximate size of the electronic submission
is displayed in the window of the gateway. This electronic submission is virus free.


  




     3


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

 


During your review of this application,
if there are any questions concerning this submission, please contact me at the information provided under my signature.


 


Sincerely,


 


Ellen Camos


Director, Regulatory Affairs


[name of subsidiary]


Phone : 919.449.4033


Alt. Phone: 218.634.3638


Fax : 888.519.0459


Email: ellen.camos@anipharmaceuticals.com


 


EXHIBIT B-2


BUYER FDA TRANSFER LETTERS


 


	


 


_________ __, 2016


 


	Jean-Marc Guettier, M.D., Director	 
	Division of Metabolism and 

Endocrinology Products (DMEP)	Acceptance
of

of NDA Ownership
	Center for Drug Evaluation and Research	 
	Food and Drug Administration	 
	5901-B Ammendale Road	 
	Beltsville, MD 20705-1266	 


 


	SUBJECT:	
        NDA 09854

        Cortrophin-Zinc (Corticotropin zinc hydroxide) Injection,
        40 Units/mL



 


Dear Dr. Guettier:


 


In accordance with 21 CFR § 314.72(a)(2),[ [name of subsidiary],
a wholly owned subsidiary of ANI Pharmaceuticals, Inc.], is accepting the transfer of ownership, including all rights to the New
Drug Application (NDA) 09854: Cortrophin-Zinc (Corticotropin zinc hydroxide) Injection, 40 Units/mL from Merck Sharp & Dohme
Corp. (Please refer to Module 1.3.1.5 Change in Ownership of an Application).


 


Merck Sharp & Dohme Corp. (Merck), a subsidiary of Merck
& Co., Inc., notified the agency of the transfer on behalf of Organon, USA Inc., which is also a subsidiary of Merck &
Co., Inc. of this ownership in the Transfer of NDA Ownership letter dated _________ __, 2016. The effective date of the change
of ownership is _________ __, 2016.


 




     4


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

  


	New Owner of NDA	 	Previous Owner of NDA
	 	 	 
	[name of subsidiary]	 	 
	210 Main Street West	 	[Merck]
	Baudette, MN 56623	 	 


 


By accepting the ownership of this NDA 09854, [name of subsidiary]
commits to all agreements, promises and conditions made by the former owner (Merck) and contained in the application. [name of
subsidiary] has received a copy of the approved application, including supplements and records that are required to be kept under
21 CFR § 314.81. If at any time during the review of the transferred records [name of subsidiary] becomes aware of absent
documents that are required, we commit to making a request from the FDA’s files under the fee schedule in 21 CFR §
20.45 of FDA’s public information regulations.


 


In accordance with 21 CFR § 314.72(b), [name of subsidiary]
will advise the FDA about any change in the conditions in the approved applications under 21 CFR § 314.70. Additionally, [name
of subsidiary] will include in the subsequent annual report any changes to the drug product’s label or labeling to change
the product’s brand or the name of the manufacturer, packer, or distributor.


 


Please note the contact information for
the Responsible official at ANI Pharmaceuticals, Inc. for all regulatory inquiries: (Refer to Module 1.3.1.2 Change in Contact/Agent).


 


	Responsible Official
	Name:	Ellen Camos
	Title:	Director, Regulatory Affairs
	Phone :	919.449.4033
	Alt. Phone:	218.634.3638
	Fax :	888.519.0459
	Email :	ellen.camos@anipharmaceuticals.com


 


The electronic submission is in the Electronic Common Technical
Document format (eCTD) and sent via the FDA Gateway; sequence 0000. The approximate size of the electronic submission is displayed
in the window of the gateway. This electronic submission is virus free.


 




     5


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

  


During your review of this application,
if there are any questions concerning this submission, please contact me at the information provided under my signature.


 


Sincerely,


 


Ellen Camos


Director, Regulatory Affairs


[name of subsidiary]


Phone : 919.449.4033


Alt. Phone: 218.634.3638


Fax : 888.519.0459


Email: ellen.camos@anipharmaceuticals.com


 


EXHIBIT C-1


 


SELLER FDA TRANSFER LETTERS


 


[MERCK LETTERHEAD]


 


_________ __, 2016


 


Jean-Marc Guettier, M.D., Acting Director


Division of Metabolism and Endocrinology Products (DMEP)


Center for Drug Evaluation and Research


Food and Drug Administration


  


NDA 08-975: Corticotrophin


General Correspondence – Transfer
of Ownership


 


Dear Dr. Guettier:


 


Merck Sharp & Dohme Corp.
(Merck), a subsidiary of Merck & Co., Inc. is filing this submission on behalf of Organon, USA Inc., which is also a subsidiary
of Merck & Co., Inc.


 


This is to inform you that as of _________ __, 2016,
Merck, holder of NDA 08-975 for Corticotrophin has transferred the NDA 08-975 to XXXX. XXXXX has assumed the
ownership and all rights and responsibilities of the referenced NDA and will also notify the Division of Metabolism and Endocrinology
Products of the transfer of NDA 08-975.


 




     6


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

  


All future correspondence and regulatory
communications concerning NDA 08-975 for Corticotrophin, should be directed to the XXXX:


 


XXXXXXXXX


Name


Address


Telephone


Fax


DUNS number:


 


E-mail


 


This submission is being submitted in accordance
with the current FDA Guidance Documents for the electronic common technical document. This submission is being transmitted through
the FDA's electronic submission gateway. Merck has taken precautions to ensure that the contents are free of computer viruses (McAfee
Agent, McAfee, Inc.), and Merck authorizes the use of anti-virus software, as appropriate.


 


Merck considers the information included
in this submission to be a confidential matter, and request that the Food and Drug Administration not make its content, public
without first obtaining the written permission of Merck.


 


For further information or questions, please contact me by phone
at [Tel. number] or email, [email]. In my absence, questions concerning the content of this submission
should be directed to [name] ([Tel. number, email]).


 


Sincerely,


 


[name]


Manager, Regulatory Affairs
International


Global Regulatory Affairs


 




     7


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

  


EXHIBIT C-2


 


SELLER FDA TRANSFER LETTERS


 


[MERCK LETTERHEAD]


 


__________ __, 2016


 


Jean-Marc Guettier, M.D., Acting Director


Division of Metabolism and Endocrinology Products (DMEP)


Center for Drug Evaluation and Research


Food and Drug Administration


  


NDA 09-854: Corticotrophin zinc hydroxide
suspension


General Correspondence – Transfer
of Ownership


 


Dear Dr. Guettier:


 


Merck Sharp & Dohme Corp.
(Merck), a subsidiary of Merck & Co., Inc. is filing this submission on behalf of Organon, USA Inc., which is also a subsidiary
of Merck & Co., Inc.


 


This is to inform you that as of __________ __,
2016, Merck, holder of NDA 09-854 for Corticotrophin zinc hydroxide suspension has transferred the NDA 09-854 to XXXX. XXXXX
has assumed the ownership and all rights and responsibilities of the referenced NDA and will also notify the Division of Metabolism
and Endocrinology Products of the transfer of NDA 09-854.


 


All future correspondence and regulatory
communications concerning NDA 09-854 for Corticotrophin zinc hydroxide suspension, should be directed to the XXXX:


 


XXXXXXXXX


Name


Address


Telephone


Fax


DUNS number:


 


E-mail


 




     8


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

  


This submission is being submitted in accordance
with the current FDA Guidance Documents for the electronic common technical document. This submission is being transmitted through
the FDA's electronic submission gateway. Merck has taken precautions to ensure that the contents are free of computer viruses (McAfee
Agent, McAfee, Inc.), and Merck authorizes the use of anti-virus software, as appropriate.


 


Merck considers the information included
in this submission to be a confidential matter, and request that the Food and Drug Administration not make its content, public
without first obtaining the written permission of Merck.


 


For further information or questions, please contact me by phone
at [Tel. number] or email, [email]. In my absence, questions concerning the content of this submission
should be directed to [name] ([Tel. number, email]).


 


Sincerely,


 


[name]


Manager, Regulatory Affairs
International


Global Regulatory Affairs


 




     9


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

  


EXHIBIT D


 


TRADEMARK ASSIGNMENT


 


This Trademark Assignment (this “Trademark
Assignment”) is made as of this [•] day of _________, 2016, by and between Merck Sharp & Dohme
Corp., a New Jersey corporation (“MSD Corp.”), and [ANI Pharmaceuticals, Inc., a Delaware corporation] (“Buyer”).
Each of MSD Corp. and Buyer is sometimes referred to herein individually as a “Party” and are referred to herein
collectively as the “Parties.”


 


RECITALS


 


WHEREAS, MSD Corp. is the owner in
the United States of the Trademark applications set forth on Schedule A attached hereto and made part hereof (collectively,
the “Purchased Trademarks”);


 


WHEREAS, Merck Sharp & Dohme B.V.
(“Seller”), an Affiliate of MSD Corp., and Buyer have entered into that certain Asset Purchase Agreement, dated
as of September 18, 2015 (the “Asset Purchase Agreement”); and


 


WHEREAS, pursuant to the Asset Purchase
Agreement, Buyer has agreed to acquire from Seller or its Affiliates, and Seller has agreed to, or to cause its Affiliates to,
sell, transfer, convey, assign and deliver to Buyer all of Seller’s or its Affiliates’ rights, title and interest in
and to the Purchased Trademarks and the goodwill of the business associated with and symbolized by the Purchased Trademarks.


 


NOW, THEREFORE, in consideration
of the mutual benefits to be derived from this Trademark Assignment and of the representations, warranties, conditions, agreements
and promises contained in the Asset Purchase Agreement, this Trademark Assignment and the other Ancillary Agreements, and other
good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally
bound, hereby agree as follows:


 


		1.	Defined Terms. Unless otherwise specifically provided herein, capitalized terms used in this Trademark Assignment and
not otherwise defined herein shall have the respective meanings ascribed thereto in the Asset Purchase Agreement.



 


		2.	Conveyance and Acceptance of Purchased Trademarks. In accordance with the provisions of the Asset Purchase Agreement,
(a) MSD Corp. hereby sells, transfers, conveys, assigns and delivers to Buyer, free and clear of any Liens other than Permitted
Liens, all of its right, title and interest in and to the Purchased Trademarks in the United States and (b) Buyer hereby accepts
such sale, transfer, conveyance, assignment and delivery.



 




     10


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

  


		3.	Recordation. MSD Corp. hereby authorizes Buyer to record this Trademark Assignment with the U.S. Patent and Trademark
Office. All costs and expenses, including Third Party filing and recordation fees and other disbursements, associated with the
conveyance of the Purchased Trademarks and with the recordation of this Trademark Assignment shall be borne solely by Buyer.



 


		4.	Asset Purchase Agreement Controls. Notwithstanding any other provision of this Trademark Assignment to the contrary,
nothing contained herein (other than in Section 3 above) shall in any way supersede, modify, replace, amend, change, rescind, waive,
exceed, expand, enlarge or in any way affect the provisions, including warranties, covenants, agreements, conditions, representations
or, in general any of the rights and remedies, or any of the obligations of Buyer or Seller set forth in the Asset Purchase Agreement.
This Trademark Assignment is subject to, and governed entirely in accordance with, the terms and conditions of the Asset Purchase
Agreement. Except as set forth in Section 3 above, nothing contained herein is intended to modify or supersede any of the provisions
of the Asset Purchase Agreement.



 


		5.	Further Assurances. MSD Corp. agrees, at Buyer’s expense, to take such further action and to execute and deliver
such additional instruments and documents as Buyer may reasonably request to carry out and fulfill the purposes and intent of this
Trademark Assignment.



 


		6.	Counterparts. This Trademark Assignment may be executed in any number of counterparts, and each such counterpart hereof
shall be deemed to be an original instrument, but all such counterparts together shall constitute but one agreement. Delivery of
an executed counterpart of a signature page of this Trademark Assignment by facsimile or other electronic transmission shall be
effective as delivery of a manually executed original counterpart of this Trademark Assignment.



 


[Signature page follows]


 




     11


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

  


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


 


	 	Merck Sharp & Dohme CORP.
	 	 	 
	 	By:	 
	 	 	Name: 
	 	 	Title:
	 	 	 
	 	[ANI PHARMACEUTICALS, INC.]
	 	 	 
	 	By:	 
	 	 	
        Name: 

	 	 	
        Title: 



 


[Signature
Page to Trademark Assignment Agreement]


 




     


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

  


	STATE OF 	________________}
	 	} ss
	COUNTY OF 	________________}


 


On this ____ day of __________, 2016, before
me personally appeared _________________, to me personally known, who, being duly sworn, did say that he/she is the ___________________
of Merck Sharp & Dohme Corp. and that he/she duly executed the foregoing instrument for and on behalf of Merck Sharp
& Dohme Corp. being duly authorized to do so and that said individual acknowledged said instrument to be the free act
and deed of said company.


 


	 	 
	Notary Public	 
	Expiration Date:___________________________________	 


 




     


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

  


	STATE OF 	________________}
	 	} ss
	COUNTY OF 	________________}


 


On this ____ day of __________, 2016, before
me personally appeared ____________________, to me personally known, who, being duly sworn, did say that he/she is the ________________________
of [ANI Pharmaceuticals, Inc.] and that he/she duly executed the foregoing instrument for and on behalf of [ANI Pharmaceuticals,
Inc.] being duly authorized to do so and that said individual acknowledged said instrument to be the free act and deed of said
company.


 


	 	 
	Notary Public	 
	Expiration Date:___________________________________	 


 




     


    Confidential Materials Omitted and Filed Separately with the Securities and Exchange 
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]


    

  


SCHEDULE A


 


PURCHASED TRADEMARKS


 


		1.	U.S. Trademark application for the Trademark CORTROPHIN, U.S. Serial No. 86534100, for “medicinal hormone preparation.”



 


		2.	U.S. Trademark application for the Trademark CORTROPHIN-ZINC, U.S. Serial No. 86534102, for “medicinal hormone preparation.”