Document:

amph_Ex10_34

		
			Exhibit 10.34
		

		
			CONFIDENTIAL TREATMENT REQUESTED 
		

		
			CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN 
		

		
			SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION 
		

		
			 
		

		
			SECOND AMENDMENT TO SUPPLY AGREEMENT
		

		
			 
		

		
			This second amendment (“Second Amendment”) to the Supply Agreement by and between MannKind Corporation (“MannKind”) and Amphastar Pharmaceuticals, Inc.  (“Amphastar”), originally dated July 31, 2014 and as previously amended on October 31, 2014 (collectively, the “Agreement”), is hereby made as of the 9th day of November, 2016, by and between MannKind on the one hand, and on the other hand, Amphastar.  
		

		
			RECITALS:
		

		
			WHEREAS, MannKind and Amphastar entered into the Agreement pursuant to which Amphastar is to manufacture and supply the Product to MannKind, and MannKind is to purchase certain minimum quantities of the Product; 
		

		
			WHEREAS, MannKind and Amphastar are concurrently entering into a first amendment to the Insulin Purchase Option Agreement originally dated January 1, 2015 (the “Option Amendment”) and
		

		
			WHEREAS MannKind and Amphastar have determined it to be mutually beneficial to amend the Agreement as set forth herein.
		

		
			NOW, THEREFORE, for good and valuable consideration, MannKind and Amphastar, hereby agree to amend the Agreement as follows:
		

		
			1.Definitions.  Unless otherwise defined herein, each of the capitalized terms used in this Second Amendment shall have the definition and meaning ascribed to it in the Agreement.
		

		
			2.Amendments to the Agreement.
		

		
			2.1     The following sentence in Section 5.1 of the Agreement:
		

		
			“Upon delivery to MannKind, AFP shall ensure Product will have a remaining expiry date of not less than four (4) years.”
		

		
			Is amended and replaced in its entirety with the following:
		

		
			“In calendar year 2017 and 2018, upon delivery to MannKind, Amphastar shall ensure that Product will have a remaining expiry date of not less than two (2) years. In calendar year 2019 and the remainder of the term of the Agreement, Amphastar shall ensure Product will have a remaining expiry date of not less than three (3) years.”   
		

		
			2.2     The following sentence in Section 6.1 of the Agreement:
		

		
			 
		

		
			“Purchase Commitment and Purchase Price. MannKind shall purchase from AFP the minimum quantities of Product (the “Purchase Commitment Quantities”) at the purchase price per gram (the “Purchase Price”) in each calendar year as provided in the table set forth below. In the event that MannKind fails to meet the Purchase Commitment 

		 

 

Quantities in any given calendar year, MannKind shall pay AFP for the difference in the amount of the Purchase Commitment Quantities and the actual amount purchased for the corresponding calendar year (such difference, the “Purchase Commitment Difference”). AFP shall issue an invoice and MannKind shall pay the Purchase Commitment Difference no later than thirty (30) days after the close of the corresponding calendar year.”  
		

		
			is amended and replaced in its entirety with the following:
		

		
			 
		

		
			Purchase Commitment and Purchase Price. MannKind shall purchase from Amphastar the minimum quantities of Product (the “Purchase Commitment Quantities”) at the purchase price per gram (the “Purchase Price”) in each calendar year as provided in the table set forth below. This annual Purchase Commitment Quantities will be divided into four (4) equal quarterly commitments (the “Quarterly Commitment”). In the event that MannKind fails to meet the Quarterly Commitment in any given calendar quarter, MannKind shall pay Amphastar for the difference in the amount of the Quarterly Commitment and the actual amount purchased for the corresponding calendar quarter (such difference, the “Payment Commitment Difference”). Amphastar shall issue an invoice and MannKind shall pay the Payment Commitment Difference no later than thirty (30) days after the close of the corresponding calendar quarter. Notwithstanding the foregoing, the parties hereby agree that the Purchase Commitment Quantities for 2017 shall not be divided into four (4) equal quarterly payments but rather MannKind shall take receipt of the entire [***] Kgs of Product in the fourth (4th) quarter of 2017 but no later than November 15, 2017.
		

		
			

		 

		

			2

		

 

		

		
			2.3The table in Section 6.1 of the Agreement is amended and replaced in its entirety with the following:
		

		
			 
		

			
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						Calendar Year

					
					
						Purchase Commitment Quantities (kg)

					
					
						Purchase Price (per gram)

					
					
						Delivery and Payment

				
	
					
						2014

					
					
						[***]

					
					
						EUR [***]

					
					
						 

				
	
					
						2015

					
					
						[***]

					
					
						EUR [***]

					
					
						 

				
	
					
						2016

					
					
						[***]

					
					
						EUR [***]

					
					
						 

				
	
					
						2017

					
					
						[***]

					
					
						EUR [***]

					
					
						100% of the Purchase Commitment Quantities Payment shall be paid no later than November 5, 2017

				
	
					
						2018

					
					
						[***]

					
					
						EUR [***]

					
					
						25% of the Purchase Commitment Quantities shall be paid on a Quarterly basis

				
	
					
						2019

					
					
						[***]

					
					
						EUR [***]

					
					
						25% of the Purchase Commitment Quantities shall be paid on a Quarterly basis

				
	
					
						2020

					
					
						[***]

					
					
						EUR [***]

					
					
						25% of the Purchase Commitment Quantities shall be paid on a Quarterly basis

				
	
					
						2021

					
					
						[***]

					
					
						EUR [***]

					
					
						25% of the Purchase Commitment Quantities shall be paid on a Quarterly basis

				
	
					
						2022

					
					
						[***]

					
					
						EUR [***]

					
					
						25% of the Purchase Commitment Quantities shall be paid on a Quarterly basis

				
	
					
						2023

					
					
						[***]

					
					
						EUR [***]

					
					
						25% of the Purchase Commitment Quantities shall be paid on a Quarterly basis

				

		
			________________________
		

		
			*** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
		

		
			2.4     Section 6.2 of the Agreement shall be amended and replaced in its entirety with the following:
		

		
			 
		

		
			6.2 Payment. In calendar year 2017 and 2018, MannKind shall pre-pay Amphastar for the Product at least ten (10) days prior to the estimated delivery date. For the avoidance of doubt, Amphastar shall not ship the Product to MannKind until such payment is received. Beginning in 2019 and for the remainder of the term of the Agreement, MannKind shall pay Amphastar for the Product within forty-five (45) days from shipment 

		 

		

			3

		

 

date of the Product. Amphastar shall submit an invoice electronically to MannKind, Attention: Account Payable, valenciaap@mannkindcorp.com. If any portion of an invoice is disputed then MannKind shall pay the undisputed amount and the Parties shall use good faith efforts to reconcile the disputed amount as soon as practicable. 
		

		
			2.5 A new Section 6.5 shall be added to the Agreement as follows:
		

		
			6.5 Right of First Refusal in China. In consideration of the amendments contained in this Second Amendment and in the Option Amendment, MannKind hereby grants Amphastar the right of first refusal to participate in the development and commercialization of Afrezza in China through a collaborative arrangement.  Specifically, Amphastar and MannKind agree that MannKind will not commence the process of obtaining approval of Afrezza in China without first providing Amphastar with (i) at least ninety (90) days prior written notice of MannKind’s intention to commence the process of obtaining approval of Afrezza in China, and (ii) if Amphastar confirms its interest in collaborating in the development or commercialization of Afrezza in China in writing within thirty (30) days of receipt of MannKind’s notice, then the Parties shall reserve sixty (60) days to negotiate in good faith the terms of such a collaborative arrangement for Afrezza in China.  In the event that the Parties are unable to agree on commercial terms for a collaborative agreement after the sixty (60) day negotiation period, then MannKind shall have the right to negotiate a collaborative agreement with another party (“Competing Terms”). MannKind shall present the Competing Terms to Amphastar in writing, and within sixty (60) days of receipt of the Competing Terms, Amphastar shall have the option to either (i) decline to match the Competing Terms, or (ii) agree to match the same Competing Terms and enter into a collaborative agreement with MannKind in China.  
		

		
			2.6   Section 10.1 of the Agreement shall be extended until December 31, 2023.  All other terms and conditions in paragraph 10.1 shall remain in full force and effect.  
		

		
			 
		

		
			3.Final Agreement.
		

		
			From and after the execution of this Second Amendment, all references in the Agreement (or in the Second Amendment) to “this Agreement,” “hereof,” “herein,” “hereto,” and similar words or phrases shall mean and refer to the Agreement as amended by this Second Amendment.  The Agreement as amended by this Second Amendment constitutes the entire agreement by and between the Parties as to the subject matter hereof.  Except as expressly modified by this Second Amendment, all other terms and conditions of the Agreement shall remain in full force and effect.
		

		
			IN WITNESS WHEREOF, each of MannKind and Amphastar has caused this Second Amendment to be executed by their duly authorized officers.
		

		
			 
		

			
					
						 

					
					
						MannKind Corporation

				
	
					
						 

					
					
						By:

					
					
						/s/ Matthew Pfeffer

				
	
					
						 

					
					
						Name:

					
					
						Matthew Pfeffer

				
	
					
						 

					
					
						Title:

					
					
						CEO

				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						 

					
					
						Amphastar Pharmaceuticals, Inc.

				
	
					
						 

					
					
						By:

					
					
						/s/ Jason Shandell

				
	
					
						 

					
					
						Name:

					
					
						Jason Shandell

				
	
					
						 

					
					
						Title:

					
					
						President

				

		
			 
		

		 

		

			4rxipc0211916

THIS CERTIFIES THAT is the owner of CUSIP DATED COUNTERSIGNED AND REGISTERED: COMPUTERSHARE TRUST COMPANY, N.A. TRANSFER AGENT AND REGISTRAR, COMMON STOCK SEE REVERSE FOR CERTAIN DEFINITIONS Certificate Number Shares . GALENA BIOPHARMA, INC. INCORPORATED UNDER THE LAWS OF THE STATE OF DELAWARE President & Chief Executive Officer By AUTHORIZED SIGNATURE COMMON STOCK PAR VALUE $0.0001 FULLY-PAID AND NON-ASSESSABLE SHARES OF THE COMMON STOCK OF Galena Biopharma, Inc. (hereinafter called the “Company”), transferable on the books of the Company in person or by duly authorized attorney, upon surrender of this Certificate properly endorsed. This Certificate and the shares represented hereby, are issued and shall be held subject to all of the provisions of the Amended and Restated Certificate of Incorporation, as amended, and the Amended and Restated By-Laws, as amended, of the Company (copies of which are on file with the Company and with the Transfer Agent), to all of which each holder, by acceptance hereof, assents. This Certificate is not valid unless countersigned and registered by the Transfer Agent and Registrar. Witness the facsimile seal of the Company and the facsimile signatures of its duly authorized officers. Vice President, Finance & Corporate Controller THIS CERTIFICATE IS TRANSFERABLE IN CANTON, MA, JERSEY CITY, NJ AND COLLEGE STATION, TX 363256 50 4 ZQ|CERT#|COY|CLS|RGSTRY|ACCT#|TRANSTYPE|RUN#|TRANS# DD-MMM-YYYY * * 0 0 0 0 0 0 * * * * * * * * * * * * * * * * * * * * * 0 0 0 0 0 0 * * * * * * * * * * * * * * * * * * * * * 0 0 0 0 0 0 * * * * * * * * * * * * * * * * * * * * * 0 0 0 0 0 0 * * * * * * * * * * * * * * * * * * * * * 0 0 0 0 0 0 * * * * * * * * * * * * * * ** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Alexander David Sample **** Mr. Sample **** Mr. Sample **000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares*** *000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares**** 000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****0 00000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****00 0000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000 000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****0000 00**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****00000 0**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000 **Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000* *Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000** Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**Shares****000000**S ***ZERO HUNDRED THOUSAND ZERO HUNDRED AND ZERO*** MR. SAMPLE & MRS. SAMPLE & MR. SAMPLE & MRS. SAMPLE ZQ00000000 Certificate Number s 1234567890/123456789 0 1234567890/123456789 0 1234567890/123456789 0 1234567890/123456789 0 1234567890/123456789 0 1234567890/123456789 0 Total Transactio n Num/No . 123456 Denom . 123456 Tota l 1234567 MR A SAMPL E DESIGN ATION (IF ANY ) ADD 1 ADD 2 ADD 3 ADD 4 PO BOX 43004, Providence, RI 02940-3004 CUSI P XXXXXX XX X Holder ID XXXXXXXXX X Insurance Value  1,000,000.0 0 Number of Share s 12345 6 DT C 12345678  12345678901234 5

 

The IRS requires that we report the cost basis of certain shares acquired after January 1, 2011. If your shares were covered by the legislation and you have sold or transferred the shares and requested a specific cost basis calculation method, we have processed as requested. If you did not specify a cost basis calculation method, we have defaulted to the first in, first out (FIFO) method. Please visit our website or consult your tax advisor if you need additional information about cost basis. If you do not keep in contact with us or do not have any activity in your account for the time periods specified by state law, your property could become subject to state unclaimed property laws and transferred to the appropriate state. The following abbreviations, when used in the inscription on the face of this certificate, shall be construed as though they were written out in full according to applicable laws or regulations: TEN COM - as tenants in common UNIF GIFT MIN ACT-  . . . . . . . . . .Custodian . . . . . . . . . . . . . . . TEN ENT - as tenants by the entireties under Uniform Gifts to Minors Act  . . . . . . . . . . . . . JT TEN - as joint tenants with right of survivorship     UNIF TRF MIN ACT  . . . . . . . . . . . . . . .Custodian (until age. . . ). . . . . . . . . . . and not as tenants in common                                                           (Cust)                                                          (Minor) under Uniform Transfers to Minors Act. . . . . . . . . . (State) Additional abbreviations may also be used though not in the above list. For value received, ____________________________hereby sell, assign and transfer unto ________________________________________________________________________________________________________________________________ ________________________________________________________________________________________________________________________________ ________________________________________________________________________________________________________________________________ _______________________________________________________________________________________________________________________ Shares _______________________________________________________________________________________________________________________ Attorney Dated: __________________________________________20__________________ Signature: ____________________________________________________________ Signature: ____________________________________________________________ Notice: The signature to this assignment must correspond with the name as written upon the face of the certificate, in every particular, without alteration or enlargement, or any change whatever. (Cust) (Minor) (State) PLEASE INSERT SOCIAL SECURITY OR OTHER IDENTIFYING NUMBER OF ASSIGNEE (PLEASE PRINT OR TYPEWRITE NAME AND ADDRESS, INCLUDING POSTAL ZIP CODE, OF ASSIGNEE) of the common stock represented by the within Certificate, and do hereby irrevocably constitute and appoint to transfer the said stock on the books of the within-named Corporation with full power of substitution in the premises. . Galena Biopharma, Inc. THE COMPANY WILL FURNISH WITHOUT CHARGE TO EACH SHAREHOLDER WHO SO REQUESTS, A SUMMARY OF THE POWERS, DESIGNATIONS, PREFERENCES AND RELATIVE, PARTICIPATING, OPTIONAL OR OTHER SPECIAL RIGHTS OF EACH CLASS OF STOCK OF THE COMPANY AND THE QUALIFICATIONS, LIMITATIONS OR RESTRICTIONS OF SUCH PREFERENCES AND RIGHTS, AND THE VARIATIONS IN RIGHTS, PREFERENCES AND LIMITATIONS DETERMINED FOR EACH SERIES, WHICH ARE FIXED BY THE AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF THE COMPANY, AS AMENDED, AND THE RESOLUTIONS OF THE BOARD OF DIRECTORS OF THE COMPANY, AND THE AUTHORITY OF THE BOARD OF DIRECTORS TO DETERMINE VARIATIONS FOR FUTURE SERIES. SUCH REQUEST MAY BE MADE TO THE OFFICE OF THE SECRETARY OF THE COMPANY OR TO THE TRANSFER AGENT. THE BOARD OF DIRECTORS MAY REQUIRE THE OWNER OF A LOST OR DESTROYED STOCK CERTIFICATE, OR HIS LEGAL REPRESENTATIVES, TO GIVE THE COMPANY A BOND TO INDEMNIFY IT AND ITS TRANSFER AGENTS AND REGISTRARS AGAINST ANY CLAIM THAT MAY BE MADE AGAINST THEM ON ACCOUNT OF THE ALLEGED LOSS OR DESTRUCTION OF ANY SUCH CERTIFICATE. Signature(s) Guaranteed: Medallion Guarantee Stamp THE SIGNATURE(S) SHOULD BE GUARANTEED BY AN ELIGIBLE GUARANTOR INSTITUTION (Banks, Stockbrokers, Savings and Loan Associations and Credit Unions) WITH MEMBERSHIP IN AN APPROVED SIGNATURE GUARANTEE MEDALLION PROGRAM, PURSUANT TO S.E.C. RULE 17Ad-15.

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