Document:

Amendment # 2 to Development & Supply Agreement

 Exhibit 10.16.2 
 [*] = CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION. 
 AMENDMENT NUMBER 2 
 To the Development and Supply Agreement dated December 28, 2001 (the Agreement) between Abbott Laboratories (“Abbott”) and InterMune, Inc. (“InterMune”), collectively the (“Parties”). 
 Abbott and InterMune agree to amend the Agreement as follows: 
 1. Section 5 shall be amended as follows: (Terms and conditions detailed in 5.1 (a) and (b) remain unchanged. The payment schedule in Exhibit C shall be replaced with Attachment A.) 
 5.1 Research and Development Fee. To reimburse Abbott for its participation in the Project, InterMune shall pay Abbott a [*] research and development fee
of [*]. The research and development fee (“Fee”) shall be paid to Abbott as follows: 
 2. Section 6.1 of the Agreement is
amended as follows: 
 6.1 Pilot Scale/Clinical Supplies. Abbott shall provide to InterMune pilot/clinical scale supplies consisting of
approximately [*] of Bulk Drug Substance, [*] Abbott. Such pilot scale lots shall yield Abbott’s best efforts, [*] per lot and shall meet the Bulk Drug Substance specifications as mutually agreed to by the Parties. 
 3. Section 6.2 of the Agreement shall be amended as follows: 
 6.2 Validation Supplies. Abbott shall provide to InterMune validation supplies consisting of [*] of Bulk Drug Substance totaling [*], or as mutually agreed to by the parties to satisfy the InterMune regulatory strategy. Such
batch lots shall meet the mutually defined Bulk Drug Substance specifications. InterMune shall notify Abbott of any alteration of the validation schedule and Bulk Drug Substance amount. 
 4. In accordance with Section 6.3 and Exhibit C, a revised delivery and payment schedule has been agreed to by the Parties and is attached hereto as
Attachment A. 
 5. The Parties agree to amend the scope of the Project as set forth in Exhibit C of the Agreement. Exhibit C of the
Agreement shall be amended to include the work set forth on Attachment B hereto. 
 Capitalized terms used herein and not otherwise defined shall have the
same meaning as under the Agreement. 
 Except as specifically set forth above, all other terms and conditions of the Agreement shall remain
in full force and effect. 
  

									
	INTERMUNE, INC.	 		 	ABBOTT LABORATORIES
					
	By:	 	/s/ Peter Van Vlasselaer	 		 	By:	 	/s/ James Burnett

									
					
	Title:	 	Sr. VP Tech. Ops	 		 	Title:	 	Sr. VP - SPD
	Date:	 	9/30/02	 		 	Date:	 	10/15/02

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

  

 1 

 Attachment A. 
 InterMune Oritavancin 2002 Annual Payment Schedule 
 [*] 
 [*] 

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

  

 2 

 Attachment A. (cont.) 
 InterMune Oritavancin 2003 Annual Payment Schedule 
 [*] 
 [*] 

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

  

 3 

 Attachment B 
  

			
	Scope Change #4 Summary	 	September 19, 2002
	[*]	 	

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

  

 4Amendment # 3 to Development & Supply Agreement

 Exhibit 10.16.3 
 AMENDMENT NUMBER 3 
 TO 
 DEVELOPMENT AND SUPPLY AGREEMENT DATED DECEMBER 28, 2001 
 BETWEEN

 ABBOTT LABORATORIES AND INTERMUNE, INC. 
 This Amendment No. 3, to the Development and Supply Agreement dated as of December 28, 2001, as amended by Amendment No. 1 dated April 26, 2002, Amendment No. 2 dated October 15, 2002,
and the letter agreement regarding “Authorization for Disclosure of Confidential Information” dated July 18, 2003 (collectively, the “Agreement”), is effective as of December 22, 2005 (“Amendment No. 3
Effective Date”) between Abbott Laboratories, an Illinois corporation (“Abbott”), and InterMune, Inc., a Delaware corporation (“InterMune”). Any capitalized term used and not otherwise defined herein shall have the meaning
set forth in the Agreement. 
 WHEREAS, the parties desire to amend the Agreement as set forth below. 
 NOW, THEREFORE, in consideration of the premises and the mutual covenants and agreements contained herein, the parties hereto, intending to be legally
bound, hereby agree as follows: 
  

	 	1.	Amendment. Abbott and InterMune hereby amend the Agreement as follows: 

  

	 	A.	Section 8.6 of the Agreement is amended and restated as follows: 

 8.6 Non-Standard Equipment or Additional Capacity. If equipment is required to manufacture Bulk Drug Substance for InterMune, InterMune shall pay the cost of such equipment, subject to InterMune’s prior
approval of such costs, which approval shall not be unreasonably withheld. Abbott shall advise InterMune of equipment required and the estimated cost(s) associated with the purchase, installation and validation of such equipment. Such equipment
shall be used exclusively for manufacturing Bulk Drug Substance hereunder or, if utilized for other products, such cost(s) shall be prorated accordingly. Abbott shall bill InterMune for the associated costs after Abbott installs the equipment.

  

	 	B.	Section 12.1 of the Agreement is amended and restated as follows: 

 12.1 Term. This Agreement shall become effective as of the Effective Date, and unless sooner terminated hereunder, shall continue in effect until December 31, 2014; provided, however, that twenty-four
(24) months prior written notice of a party’s intent to terminate this Agreement is given to the other party. THEREAFTER, THIS AGREEMENT SHALL STAY IN EFFECT FOR RECURRENT ADDITIONAL TWO (2) YEAR PERIODS, UNLESS TWELVE
(12) MONTHS PRIOR WRITTEN NOTICE OF A PARTY’S INTENT TO TERMINATE IS GIVEN TO THE OTHER PARTY. 

	 	C.	A new Section 12.6 of the Agreement is hereby added to the Agreement and shall read as follows: 

 12.6 Abbott Termination of Rights. In the event InterMune fails to obtain NDA approval by January 1, 2010, Abbott shall have
the right to terminate this Agreement. 
  

	 	D.	A new Section 12.7 of the Agreement is hereby added to the Agreement and shall read as follows: 

 12.6 Actions on Termination. 
  

	 	(a)	Upon expiration or termination of this Agreement for any reason by InterMune, upon InterMune’s request, Abbott will reasonably assist InterMune with the technology transfer of
the manufacturing process associated with Bulk Drug Substance to InterMune or its designee, and InterMune shall pay Abbott’s reasonable costs and expenses for such assistance. 

  

	 	(b)	Upon termination of this Agreement for any reason by Abbott, upon InterMune’s request, Abbott will reasonably assist InterMune with the technology transfer of the manufacturing
process associated with Bulk Drug Substance to InterMune or its designee, and Abbott shall pay Abbott’s reasonable costs and expenses for such assistance. 

  

	 	2.	Miscellaneous. 

  

	 	A.	All terms and conditions set forth in the Agreement that are not amended hereby shall remain in full force and effect. 

  

	 	B.	This Amendment shall be governed by and construed in accordance with the substantive law of the State of New York, without regard to the conflicts of law provisions thereof’,
and any dispute arising out of or in connection with this Amendment shall be governed by the alternative dispute resolution provisions of Exhibit E of the Agreement. 

  

	 	C.	This Amendment may be executed in counterparts, each of which shall be deemed an original, but all of which will constitute one and the same instrument. 

  

	 	D.	Any term of this Amendment may be amended with the written consent of both parties. 

  

	 	E.	This Amendment is the product of both of the parties hereto, and together with the Agreement constitutes the entire agreement between such parties pertaining to the subject matter
hereof, and merges all prior negotiations and drafts of the parties with regard to the matters set forth herein. 

  

	 	F.	From the date hereof, any reference to the Agreement shall be deemed to refer to the Agreement as amended by this Amendment. 

  

 2 

 IN WITNESS WHEREOF, the parties, through their authorized officers, have executed this Amendment as of
the Amendment No. 3 Effective Date. 
  

					
	INTERMUNE, INC.	 		 	ABBOTT LABORATORIES
			
	/s/ Tom Kassberg	 		 	/s/ Mike L. McGibbon
	Name: Tom Kassberg	 		 	Name: Mike L. McGibbon
	Title: Sr. VP Business Development	 		 	Title: General Manager, Pharma
	Dated: December 16, 2005	 		 	Dated: December 20, 2005

  

 3Amendment # 4 to Development & Supply Agreement

 Exhibit 10.16.4 
 [*] = CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION. 
 AMENDMENT NUMBER 4 TO THE 
 DEVELOPMENT AND SUPPLY AGREEMENT DATED DECEMBER 28, 2001 
 BETWEEN 
 ABBOTT LABORATORIES AND INTERMUNE, INC. (TARGANTA 
 THERAPEUTICS) 
 This Fourth Amendment, to the Development and Supply Agreement dated as of
December 28, 2001, as amended by Amendment Number 1 dated April 26, 2002, Amendment Number 2 dated October 15, 2002, and Amendment Number 3 dated December 22, 2005 (the “Agreement”), is effective as of December 15,
2006 (“Amendment Effective Date”), between Abbott Laboratories, an Illinois corporation (“Abbott”), and Targanta Therapeutics Corporation, an Indianapolis, Indiana corporation (“Targanta”) as purchaser of all rights
title and interest related to Oritavancin from InterMune, Inc., a Delaware corporation (“InterMune”). Any capitalized term used and not otherwise defined herein shall have the meaning set forth in the Agreement. 
 WHEREAS, the parties desire to amend the Agreement to revise certain provisions relating to the forecasts for the Product and/or Bulk Drug Substance;

 WHEREAS, InterMune sold to Targanta and Targanta purchased from InterMune all rights, title and interest in Oritavancin, including,
without limitation, the contractual rights and obligations contained in the Agreement and this Agreement was automatically assigned to Targanta in accordance with Section 15 of the Agreement. 
 NOW, THEREFORE, in consideration of the premises and the mutual covenants and agreements contained herein, the parties hereto, intending to be legally
bound, hereby agree as follows: 
  

	 	1.	Amendment. Abbott and Targanta hereby amend the Agreement as follows: 

  

	 	A.	All reference to InterMune or InterMune, Inc. shall be deleted and replaced with Targanta Therapeutics (“Targanta”), as applicable (excluding the reference to InterMune
contained in Section 5.1 and 6.2 hereof) and Targanta agrees to be bound by and assume all rights, obligations and liabilities as set forth in the Agreement and all references to “party” or “parties” shall refer to Abbott,
Targanta and/or both, as may be applicable. 

  

	 	B.	Exhibit C of the Agreement shall be modified to include a Stage 4 development program for [*] and manufacture of three cGMP batches of Bulk Drug Substance (“Stage 4
Project”). 

  

	 	1.	The Stage 4 Project attached hereto as Attachment 1 shall be added to Exhibit C of the Agreement. 

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

	 	C.	Section 5.1 of the Agreement shall be deleted in its entirety and replaced with the following: 

 Research and Development Fee. The parties acknowledge and agree that Abbott has been paid in full for its participation in the Project for Stages
1 – 3 of the Project. The parties further agree that to reimburse Abbott for its participation in the Stage 4 Project, Targanta shall pay Abbott a [*] research and development fee [*] (the “Fee”). The Fee shall be paid
on a [*] basis as broken down in the Payment Schedule Forecast set forth in Exhibit C and is mutually exclusive and in addition to the research and development fee already paid by InterMune for the completion of Stages 1, 2, and 3. Invoices
shall be sent to Targanta on a [*] basis and payment for the applicable Fee for that period shall be made within [*] of receipt of each applicable invoice. If milestones in the Stage 4 Project are reached earlier than forecasted, the
Stage 4 Project will move to the next area of focus with a commensurate reduction in the forecasted fees, if applicable, and any such adjusted fee shall be set forth in writing. 
  

	 	D.	Section 6.2 of the Agreement shall be deleted and replaced with the following: 

 Validation Supplies. Abbott has provided to InterMune validation supplies consisting of [*] of Bulk Drug Substance. As a component of the development activities described in the Stage 4 Project set forth
in Exhibit C, Abbott shall supply to Targanta [*] of Bulk Drug Substance for clinical, regulatory, and/or commercial use. The [*] shall target [*] of Bulk Drug Substance and incorporate [*] defined in the Stage 4 Project.

  

	 	E.	Section 8.3(b) of the Agreement shall be deleted and replaced with the following: 

 Quality Assurance. Within [*] following the signing of this amendment, representatives of the parties’ Quality Assurance departments shall meet to develop and approve a quality agreement
(“Quality Agreement”) outlining the responsibilities and key contacts for quality and compliance related issues. Items to be included in the Quality Agreement include, but are not limited to, recalls, annual product reviews, returned
goods, regulatory audits, compliance with cGMP, and compliance with such other quality related concerns deemed appropriate. 
  

	 	F.	Section 8.5(b) (Abbott Bank Information only) of the Agreement shall be deleted and replaced with the following: Account Name: 

  

			
	 Account Name:
	  	[*]
	 Account Number:
	  	[*]
	 Bank:
	  	[*]
	 ABA Number: [*]
	  	[*]

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

  

 2 

	 	G.	Section 8.6 of the Agreement is modified to add the following information to the end of the paragraph: 

 The parties acknowledge and agree that equipment modifications are necessary for the Stage 4 Project and for continued commercial production of Bulk Drug
Substance thereafter. The parties acknowledge that equipment modifications are estimated to be approximately [*], but are subject to change, and shall be billed by Abbott to Targanta at Abbott’s cost, as the aforementioned equipment
modifications occur. Notwithstanding the foregoing, in the event the equipment modifications are anticipated to [*] (the “Maximum Equipment Fee”), Abbott shall obtain Targanta’s prior written approval of the costs in excess of
the Maximum Equipment Fee before commencing such equipment modifications. 
  

	 	H.	Section 12.3 of the Agreement is deleted in its entirety. 

  

	 	I.	Section 12.7(a) is modified to read as follows: 

 Upon expiration or termination of this Agreement for any reason by Targanta, upon Targanta’s request, Abbott will reasonably assist Targanta with the technology transfer of the manufacturing process associated with Bulk Drug Substance
to Targanta or its designee, and Targanta [*]. 
  

	 	J.	Section 12.7(b) is modified to read as follows: 

 Upon termination of this Agreement for any reason by Abbott (excluding for Targanta’s uncured breach), upon Targanta’s request, Abbott will reasonably assist Targanta with the technology transfer of the manufacturing process
associated with Bulk Drug Substance to Targanta or its designee, and Abbott [*]. 
  

	 	K.	Add Section 12.7(c) to the agreement to read as follows: 

 Upon expiration or termination of this Agreement by Abbott for Targanta’s uncured breach of this Agreement, upon Targanta’s request and upon Targanta’s payment of (i) any payments due to Abbott for services rendered or
Bulk Drug Substance provided under the Agreement prior to termination and (ii) Abbott’s reasonable costs and expenses for Abbott’s assistance of Targanta with the technology transfer of the manufacturing process associated with Bulk
Drug Substance to Targanta or its designee, Abbott will reasonably assist Targanta with such technology transfer. 

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

  

 3 

	 	L.	Section 16 is modified to update the contact information as follows: 

  

			
	 If to Abbott:
	  	 Abbott Laboratories
 President
 Globe Pharmaceutical Manufacturing
 Department 390, Building A1
 1401 Sheridan Road
 North Chicago, IL 60064-4000
 Facsimile: 847-938-2315

		
	 with copy to:
	  	 Abbott Laboratories
 100 Abbott Park Road
 Building AP6A-2, Dept. 323
 Abbott Park, Illinois 60064-6011
 Attn: Associate General Counsel, Pharmaceutical
 Product Group Legal
Operations
 Facsimile: 847-938-1342

		
	 If to Targanta:
	  	 Targanta Therapeutics
 Vice President, Operations and
Manufacturing
 225 South East Street, Suite 390
 Indianapolis, IN
46202
 Facsimile: 317-536-7737

  

	 	2.	Miscellaneous. 

  

	 	A.	All terms and conditions set forth in the Agreement that are not amended hereby shall remain in full force and effect. 

  

	 	B.	This Amendment shall be governed by and construed in accordance with the substantive law of the State of New York, without regard to the conflicts of law provisions thereof, and any
dispute arising out of or in connection with this Amendment shall be governed by the alternative dispute resolution provisions set forth in Exhibit E of the Agreement. 

  

	 	C.	This Amendment may be executed in counterparts, each of which shall be deemed an original, but all of which will constitute one and the same instrument. 

  

	 	D.	Any term of this Amendment may be amended with the written consent of both parties. 

  

	 	E.	This Amendment is the product of both of the parties hereto, and together with the Agreement constitutes the entire agreement between such parties pertaining to the subject matter
hereof, and merges all prior negotiations and drafts of the parties with regard to the transactions contemplated herein. 

  

	 	F.	From the date hereof, any reference to the Agreement shall be deemed to refer to the Agreement as amended by this Amendment. 

  

 4 

 IN WITNESS WHEREOF, the parties, through their authorized officers, have executed this Amendment as of
the Amendment Effective Date. 
  

									
	TARGANTA CORPORATION	 		 	ABBOTT LABORATORIES
					
	Signature:	 	/s/ PIERRE ETIENNE	 		 	Signature:	 	/s/ MIKE L. MCGIBBON
	Name:	 	Pierre Etienne, M.D.	 		 	Name:	 	Mike L. McGibbon
	Title:	 	Chief Development Officer	 		 	Title:	 	G.M., Commercial Ops.

  

 5 

 Attachment 1 
 Exhibit C - Stage 4 
 STAGE 4 ORITAVANCIN [*] 
 ASM FREE, PROCESS DEMONSTRATION & 
 COMMERCIAL MANUFACTURING 
 CONFIDENTIAL 
 No use or disclosure outside Abbott is permitted without prior written authorization from Abbott. 
 Stage 4 Project 
  

			
	 Step 1
	  	 [*]

		
	 Step 2
	  	Nucleus Demonstration at Commercial Scale
		
	 Step 3
	  	Commercial Scale Validation Manufacturing

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

  

 6 

 Exhibit C - Stage 4 
 TARGANTA DEVELOPMENT PROPOSAL 
 [*] 

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

  

 7

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00125-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00125-of-00352.parquet"}], [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00125-of-00352.parquet"}]]