Exhibit 10.1


 


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: [***]


 


AMENDMENT NO. 2 TO ASSET PURCHASE
AGREEMENT


 


This Amendment No.
2 to Asset Purchase Agreement is dated as of July 10, 2015 (the "Amendment") and is by and between Teva Pharmaceuticals
USA, Inc., a Delaware corporation and those of its affiliates that own the Amendment No. 2 ANDAs (as defined below) (collectively,
"Teva"), on the one hand, and ANI Pharmaceuticals, Inc., a Delaware corporation ("Buyer") on
the other hand.


 


WHEREAS, Buyer and
Teva are parties to that certain Asset Purchase Agreement effective as of December 26, 2013, as amended by Amendment No. 1 (defined
below) (the "Original Agreement"), pursuant to which Buyer acquired the Purchased Assets from Teva;


 


WHEREAS, Buyer and
Teva entered into Amendment No. 1 to Asset Purchase Agreement as of March 4, 2015 ("Amendment No. 1"), pursuant
to which Buyer acquired the New ANDAs from Teva on the same terms and conditions as the Original Agreement, except for changes
required to reflect (i) the date of the purchase of the New Purchased Assets thereunder, (ii) the payment of the Third Payment
upon execution of the New Bill of Sale and (iii) a different Royalty percentage to be paid with respect to the New Products under
the New ANDAs, in each case as reflected in Amendment No. 1 (with all such capitalized terms having the same meaning as defined
in Amendment No. 1);


 


WHEREAS, Teva owns
those additional ANDAs that are set forth on Exhibit A hereto (the "Amendment No. 2 ANDAs"), with respect
to the generic pharmaceutical products set forth on such Exhibit A (the "Amendment No. 2 Products") that
Buyer also wishes to acquire on and pursuant to the terms of the Original Agreement, as amended hereby; and


 


WHEREAS, Teva has agreed
to sell Buyer the Amendment No. 2 ANDAs pursuant to the terms of the Original Agreement as amended hereby.


 


NOW, THEREFORE, in
consideration of the mutual covenants and conditions hereinafter expressed, Buyer and Teva agree as follows:


 





1.          Upon
the terms and subject to the conditions of the Original Agreement and this Amendment, as promptly as practicable, but in no event
later than ten (10) Business Days after the date hereof, (A) Teva will transfer, sell, convey, assign and deliver to Buyer the
Amendment No. 2 ANDAs and the related documents whether in paper or electronic form the related documents, only to the extent
made available to Buyer for inspection at its Horsham, PA site on June 23, 2015 (the "Amendment No. 2 Purchased Assets")
and Buyer will purchase, accept and assume, all of Teva's right, title and interest in and to the Amendment No. 2 Purchased Assets
and (B) the Parties shall execute and deliver a Bill of Sale with respect to such Amendment No. 2 Purchased Assets, in the form
attached hereto as Exhibit B (the "Amendment No. 2 Bill of Sale").







 





2.          Upon
execution of the Amendment No. 2 Bill of Sale and delivery by Teva of the Amendment No. 2 Purchased Assets to Buyer in accordance
with Section 1, Buyer shall pay to Teva, by wire transfer of immediately available funds into an account designated in writing
to Buyer by Teva, the sum of Twenty Five Million U.S. Dollars ($25,000,000) (the "Amendment No. 2 Payment").







 




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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.          From
and after the delivery of the Amendment No. 2 Payment, with respect to the Amendment No. 2 Purchased Assets, Buyer will be in control
of and responsible for the Liabilities involving the Amendment No. 2 Products, as set forth in Section 5 of the Original Agreement,
mutatis mutandis.


 


4.          Undefined
capitalized terms used herein shall have the meanings ascribed to them in the Original Agreement; provided, however, that it is
understood and agreed that the following definitions are hereby further amended as follows:


 


a.           The
term "ANDAs" shall include the Amendment No. 2 ANDAs from and after the date hereof.


 


b.        The term "Assumed Liabilities"
shall include the Liabilities set forth in Section 4 of the Original Agreement with respect to the Amendment No. 2 Purchased Assets
from and after the date hereof.


 


c.           The
term "Bill of Sale" shall include the Amendment No. 2 Bill of Sale from and after the date hereof.


 


d.           The
term "Products" shall include the Amendment No. 2 Products from and after the date hereof.


 


e.           The
term "Purchased Assets" shall include the Amendment No. 2 Purchased Assets from and after the date hereof.


 


f.            The
term "Up-Front Payments" shall include the Amendment No. 2 Payment from and after the date hereof.


 


g.           For
purposes of Sections 6(c) and 6(e) of the Original Agreement only, the date hereof shall be deemed the "Effective Date"
with respect to the Amendment No. 2 ANDAs and the Amendment No. 2 Purchased Assets.


 


5.          It
is understood and agreed that with respect to the Amendment No. 2 Products, the Royalty, as set forth in the Original Agreement,
including Exhibit C thereof, shall be equal to [***] percent ([***]%) and that the Royalty Term shall be from Product Year
One through Product Year [***].


 


6.          Each
of Teva and Buyer restate the representations and warranties set forth in Section 7 of the Original Agreement as of the date hereof
(which, for purposes of clause (b) thereof, shall be limited to the Amendment No. 2 Purchased Assets) and agree that they shall
survive and remain operative and in full force and effect for a period of twelve (12) months following the date hereof.







 




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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: [***]


 





7.          Teva
shall dispatch a letter to FDA in the form set forth in Exhibit D of the Original Agreement with respect to the Amendment
No. 2 ANDAs, with such changes as may be applicable to reflect the transactions contemplated by this Amendment, within five (5)
Business Days after Buyer's payment to Teva of the Amendment No. 2 Payment.


 


8.          Within
five (5) days after Teva has sent the letter referenced in Section 7 hereof, Buyer shall send a letter to the FDA indicating that
the transfer from Teva of the Amendment No. 2 ANDAs has been accepted by the Buyer and that the Buyer is the new owner of the Amendment
No. 2 ANDAs as of the date hereof, and Buyer shall promptly provide Teva with a copy of said letter.


 


9.          The
recitals set forth above are deemed incorporated herein and a part hereof. All necessary conforming changes to the Original Agreement
occasioned by reason of this Amendment are hereby deemed to be made. Except as amended hereby, the Original Agreement shall remain
in full force and effect and is in all respects hereby ratified and affirmed.


 


10.          This Amendment may be executed
in two or more counterparts, each of which shall be deemed an original bit all of which, taken together, shall constitute one and
same instrument. PDF and facsimile signatures shall constitute original signatures.







 


[The remainder of this page is intentionally
left blank]


 




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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 Amendment as of the date first written above.


 


	TEVA PHARMACEUTICALS USA, INC.	 
	 	 
	By: 	/s/ Vikram Seoni	 
	Name: Vikram Seoni	 
	Title: SVP, BD & Alliance MGMT	 
	 	 
	By:	 /s/ Brian McCrudden	 
	Name: Brian McCrudden	 
	Title: Sr. Director, Alliance MGMT	 
	 	 
	ANI PHARMACEUTICALS, INC.	 
	 	 
	By: 	/s/ Charlotte Arnold	 
	Name: Charlotte Arnold	 
	Title: Vice President & CFO	 


 




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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


 


	ANDA#	 	Molecule	 	Form	 	Strength
	 	 	 	 	 	 	 
	065190	 	Cefuroxime 	 	Tablets	 	250, 500 mg
		 	Axetil	 	 	 	 
	084910, 085032,	 	Amitriptyline 	 	Tablets	 	10, 25, 
	085031 085030	 	Hydrochloride	 	 	 	50, 75 mg
	074085	 	Alprazolam*	 	Tablets	 	0.25, 0.5, 
	 	 	 	 	 	 	1, 2 mg
	070028	 	Sulfamethoxazole / 	 	Oral	 	200/5, 
	 	 	Trimethoprim*	 	Suspension	 	40/5 mg/mL
	084975, 084657	 	Meclizine 	 	Tablets	 	12.5, 25 mg
	 	 	Hydrochloride	 	 	 	 
	077396	 	Lorazepam*	 	Tablets	 	0.5, 1, 2 mg
	086727	 	Diphenoxylate
    HCI / Atropine Sulfate	 	Tablets	 	2.5/0.025 mg
	074387, 074497	 	Glipizide	 	Tablets	 	5, 10 mg
	075898, 075897	 	Fluvoxamine 	 	Tablets	 	25, 50, 
	 	 	Maleate*	 	 	 	100 mg
	040512	 	Pyridostigmine	 	Tablets	 	30, 60 mg
	 	 	Bromide*	 	 	 	 
	074498, 074299	 	Indapamide	 	Tablets	 	1.25, 2.5 mg
	072972, 072973	 	Sulindac	 	Tablets	 	150, 200 mg
	074970, 073467	 	Triamterene / HCTZ	 	Tablets	 	37.5/25 mg
	062055	 	Erythromycin 	 	 	 	 
	 	 	Ethylsuccinate	 	 	 	 
	070869, 070870	 	Acetohexamide	 	Tablets	 	250, 500 mg
	074554	 	Cholestyramine	 	Oral Susp.	 	4 g/packet

    4 g/scoop
	073282	 	Clemastine Fumarate	 	Tablets	 	1.34 mg
	071144	 	Ibuprofen	 	Tablets	 	200 mg
	072901	 	Ibuprofen	 	Tablets

    (0.406" round diameter)	 	200 mg
	072903	 	Ibuprofen	 	Tablets (Caplets)	 	200 mg
	062222	 	Oxacillin Sodium	 	Capsules	 	250, 500 mg
	083734	 	Probenecid / Colchicine	 	Tablets	 	500/0.5 mg
	070704, 070705	 	Propranolol HCl / HCTZ	 	Tablets	 	40/25,

    80/25 mg
	072042, 072043	 	Propranolol HCl / HCTZ	 	Tablets	 	40/25,

    80/25 mg
	080142	 	Sulfisoxazole	 	Tablets	 	500 mg









 




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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


 


Form of Amendment No. 2 Bill of Sale


 


THIS BILL OF SALE
(the "Amendment No. 2 Bill of Sale"), dated as of July 10, 2015, is made and delivered by Teva
Pharmaceuticals USA, Inc., a corporation organized under the laws of the State of Delaware and those of its affiliates that
own the Amendment No. 2 ANDAs (as defined in the Amendment) ("Teva"), to ANI Pharmaceuticals, Inc., a
company organized under the laws of the State of Delaware ("Purchaser"), (each a “Party”,
collectively the “Parties”).


 


WHEREAS, pursuant to
that certain asset purchase agreement, dated as of December 26, 2013, by and between Teva and Purchaser, as amended by Amendment
No. 1 to the Asset Purchase Agreement, dated as of March 4, 2015 (the “Purchase Agreement”) and as further amended
by Amendment No. 2 to the Asset Purchase Agreement, dated as of July 10, 2015 (such Amendment No. 2, the "Amendment"),
Teva has agreed to transfer, sell, convey, assign and deliver to Purchaser, and Purchaser has agreed to purchase, accept and assume
as of the date hereof, all right, title and interest, within the Territory, of the Amendment No. 2 Purchased Assets (as defined
in the Amendment); and


 


WHEREAS, the Parties
desire to deliver to each other such instruments as are required in order to effectuate and evidence the sale by Teva and purchase
by Purchaser of the Amendment No. 2 Purchased Assets.


 


NOW, THEREFORE, in
consideration of the premises and in accordance with the provisions of the Purchase Agreement, as amended by the Amendment and
for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, Teva and Purchaser hereby
each agree as follows:


 


		1.	The terms of the Purchase Agreement, as amended by the Amendment are incorporated herein by reference
and capitalized terms used but not defined in this Amendment No. 2 Bill of Sale shall have the meanings ascribed thereto in the
Purchase Agreement, as amended by the Amendment.



 


		2.	Teva hereby irrevocably and unconditionally transfers, sells, conveys, assigns, and delivers to
Purchaser, and Purchaser hereby irrevocably and unconditionally purchases, accepts and assumes, all of Teva's right, title and
interest, within the Territory, in and to all of the Amendment No. 2 Purchased Assets, free and clear of any liens, charges or
other encumbrances.



 




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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.	The Parties, their respective divisions, subsidiaries, officers, directors, employees, stockholders,
agents, representatives, advisors, consultants, attorneys, independent contractors and successors and assigns hereby release and
discharge the other and their respective Affiliates, divisions, subsidiaries, officers, directors, employees, stockholders, agents,
representatives, advisors, consultants, attorneys, independent contractors and successors and assigns, from any and all claims,
causes of actions, obligations, investigations, demands, suits and/or liabilities, of any nature whatsoever, whether asserted or
unasserted, known or unknown, or suspected or unsuspected to exist from the beginning of time, in any way arising under or in any
way relating to the Amendment No. 2 Purchased Assets, except with respect to fraud or any representation, warranty or covenant
expressly made by it in the Purchase Agreement, as amended by the Amendment.



 


		4.	All of the terms and provisions of this Amendment No. 2 Bill of Sale shall be binding upon Teva
and its successors and assigns, and shall be binding upon Purchaser and its successors and assigns.



 


		5.	This Amendment No. 2 Bill of Sale and any all matters arising directly or indirectly herefrom shall
be governed by and construed and enforced in accordance with the laws of the State of New York, U.S.A. applicable to agreements
made and to be performed entirely in such State.



 


		6.	It is acknowledged and agreed that this Amendment No. 2 Bill of Sale is intended to document the
sale and assignment of the Amendment No. 2 Purchased Assets to Purchaser.



 


		7.	This Amendment No. 2 Bill of Sale may be executed by PDF and in one or more counterparts, each
of which shall be deemed an original and all of which together shall constitute a single instrument.



 




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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 undersigned have
executed this Amendment No. 2 Bill of Sale as of the date first set forth above.


 


	TEVA PHARMACEUTICALS USA, INC.  	 
	 	 	 
	By:	/s/ Vikram Seoni	 
	 	Name: Vikram Seoni	 
	 	Title: SVP, BD & Alliance MGMT	 
	 	 	 
	By:	/s/ Brian McCrudden	 
	 	Name: Brian McCrudden	 
	 	Title: Sr. Director, Alliance MGMT	 
	 	 	 
	ANI PHARMACEUTICALS, INC.	 
	 	 	 
	By:	/s/ Charlotte Arnold	 
	 	Name: Charlotte Arnold	 
	 	Title: Vice President & CFO	 


 




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