Document:

rdhl_Ex4_12

		
			Exhibit 4.12
		

		
			 
		

		
			Confidential
		

		
			 
		

		
			THE SYMBOL "[****]" DENOTES PLACES WHERE PORTIONS OF THIS DOCUMENT HAVE BEEN OMIITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. SUCH MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
		

		
			 
		

		
			AMENDMENT NO. 1 TO EXCLUSIVE COMMERCIALIZATION AGREEMENT
		

		
			 
		

		
			This Amendment No.1 to Exclusive Commercialization Agreement is made effective as of August 24, 2018 by and between RedHill Biopharma Ltd. (“RedHill”) and Concordia Pharmaceuticals Inc., by way of its Barbados branch (“Concordia”).
		

		
			WITNESETH
		

		
			 
		

		
			WHEREAS, Concordia and RedHill entered into an Exclusive Commercialization Agreement dated December 30, 2016 (the “Main Agreement”);
		

		
			WHEREAS, Concordia and RedHill desire to amend the Main Agreement;
		

		
			NOW, THEREFORE, in consideration of the mutual promises and covenants set forth herein, the Parties hereby agree as follows:
		

		
			1.         All terms not otherwise defined herein shall have the meaning ascribed thereto in the Main Agreement, unless the context requires otherwise.
		

		
			2.         In accordance with Section 20.6 of the Main Agreement, the Main Agreement is amended as follows:
		

		
			2.1.      Section 1.4 of the Main Agreement is hereby amended effective October 1, 2018 by the deletion of the second sentence thereof so that Section 1.4 in its entirety is as follows:
		

		
			“1.4      “Applicable Percentage” means [****]”
		

		
			2.2.      The following provision shall be added to the Main Agreement as a new Section 9.6:
		

		
			“Concordia shall pay RedHill two (2) one-time payments as follows: (i) $[****] to be paid on or before [****]; and (ii) $ [****] for [****] to be paid on or before [****].  In consideration for [****] RedHill: (i) has provided [****]; and (ii) continue, until September 30, 2018, Promotion and commercialization of the Product for the Field of Use (with the number of representatives throughout geographical territories) substantially similar to that provided through the first half of 2018; subject, inter alia, to reassignment and prompt replacement of representatives and other ordinary course and commercially reasonable changes in the geographical territories.
		

		
			2.3.      The following provision shall be added to the Main Agreement as the last sentence of Section 9.2:
		

		
			
		

		
			

		 

 

		

		
			“All amounts paid or payable by Concordia to RedHill pursuant to the applicable Quarterly Report shall, absent fraud or manifest error, be considered final and binding and shall not be subject to dispute or adjustment.”
		

		
			3.         Except as specifically amended herein, the provisions of the Main Agreement shall continue in full force and effect.
		

		
			4.         This Amendment No. 1 may be executed in any number of counterparts, each of which shall be deemed an original, but all of which shall constitute one and the same instrument.
		

		
			 
		

		
			IN WITNESS WHEREOF, the parties have executed this Amendment as of the date first above written.
		

		
			 
		

		
			 
		

			
					
						RedHill Biopharma Ltd.

					
					
						    

					
					
						Concordia Pharmaceuticals Inc.,

				
	
					
						 

					
					
						 

					
					
						S.à.r.l., Barbados Branch

				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						By:

					
					
						/s/ Dror Ben-Asher

					
					
						 

					
					
						By: 

					
					
						/s/ Robert Ford

				
	
					
						Name: Dror Ben-Asher

					
					
						 

					
					
						Name: Robert Ford

				
	
					
						Title: CEO

					
					
						 

					
					
						Title: Managing Director & Vice-President,

				
	
					
						 

					
					
						 

					
					
						Legal Affairs

				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						By: 

					
					
						/s/ Micha Ben Chorin

					
					
						 

					
					
						 

				
	
					
						Name: Micha Ben Chorin

					
					
						 

					
					
						 

				
	
					
						Title: CFO

					
					
						 

					
					
						 

				
	
					
						August 26, 2018rdhl_Ex4_14

		
			Exhibit 4.14
		

		
			 
		

		
			First Addendum
		

		
			Exclusive Licensing Agreement
		

		
			 
		

		
			This First Addendum to the Agreement (as defined below) is made and entered into between Licensor and Licensee as of the Effective Date of the Agreement.
		

		
			 
		

		
			RECITALS
		

		
			 
		

		
			WHEREAS, the Licensor and Licensee are parties to an Exclusive License Agreement made and entered into as of April 4, 2017 (the "Agreement").
		

		
			 
		

		
			WHEREAS, the Licensed Product was sold by Licensor in the Territory since August 2013 up to the RedHill Launch which occurred June 12, 2017 (the “Licensor Sales”).
		

		
			 
		

		
			WHEREAS, Licensee has been selling the License Product exclusively in the Territory pursuant to the terms and conditions of the Agreement since the RedHill Launch (the "Licensee Sales").
		

		
			 
		

		
			WHEREAS, the Licensor and Licensee both desire to enter into this First Addendum to the Agreement to establish the responsibilities of each party as they relate to customer returns of the Licensed Product ("Returns") which may occur during and after the Term of the Agreement.
		

		
			 
		

		
			NOW, THEREFORE, in consideration of the mutual promises and conditions contained in this First Addendum and in the Agreement, and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged by, the parties agree as follows:
		

		
			 
		

		
			1.0       Definitions. Capitalized terms not otherwise defined herein shall have the meaning ascribed to them in the Agreement.
		

		
			 
		

		
			2.0       Returns. The parties hereby agree that the responsibilities, conditions and process for returns as outlined in Attachment A to this First Addendum are hereby agreed to and incorporated into this First Addendum and the Agreement in their entirety.
		

		
			 
		

		
			3.0       Survival. The terms and conditions of this First Addendum shall survive the Expiration Date and the Termination Date.
		

		
			 
		

		
			IN WITNESS WHEREOF, the parties hereto have caused this First Addendum to the Agreement to be executed as of the Effective Date.
		

		
			 
		

		
			 
		

			
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						LICENSOR

					
					
						    

					
					
						 

				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						Entera Health, Inc.

					
					
						 

					
					
						 

				
	
					
						By: 

					
					
						/s/ Aage Lauridsen

					
					
						 

					
					
						LICENSEE

				
	
					
						Date: 

					
					
						July 25, 2018

					
					
						 

					
					
						 

				
	
					
						Title: 

					
					
						CEO

					
					
						 

					
					
						RedHill Biopharma, Inc.

				
	
					
						 

					
					
						 

					
					
						By: 

					
					
						/s/ Dror Ben-Asher 

					
					
						/s/ Micha Ben Chorin

				
	
					
						 

					
					
						 

					
					
						Date: 

					
					
						July 18, 2018

					
					
						July 18, 2018

				
	
					
						 

					
					
						 

					
					
						Title: 

					
					
						CEO

					
					
						CFO

				

		
			 
		

		
			 
		

		
			

		 

		

			1

		

 

		

			confidential

		

		

			 

		

		

		
			First Addendum
		

		
			Exclusive License Agreement
		

		
			 
		

		
			Attachment A
		

		
			 
		

		
			Returns
		

		
			 
		

		
			The actual processing of all Returns will be the responsibility of Licensee through the earlier of the Expiration Date or Termination Date. Thereafter processing of such returns shall be the responsibility of the Licensor or its designated future licensee. Either party may use a logistics vendor to fulfill its processing responsibilities.
		

		
			 
		

		
			The cost of any credit issued to the customer relating to a Return shall be the responsibility of the Licensor for any Licensor sales and the Licensee for any Licensee sales.
		

		
			 
		

		
			The cost that Licensor will reimburse to Licensee for Returns of Licensor sales processed by Licensee will be limited to the sales price of the Licensed Product at the time of the Licensor sale (i.e., Licensor WAC) less 10%.  The cost that Licensee will reimburse to Licensor for Returns of Licensee sales processed by Licensor will be limited to the sales price of the Licensed Product at the time of the Licensee sale (i.e., Licensee WAC) less 10%. For the avoidance of doubt, the cost of any credit issued to a customer relating to a Return which is the responsibility of the Licensee shall be deducted from Net Sales.
		

		
			 
		

		
			Any Licensor Sales Returned to Licensee will be destroyed in the manner required by the SOP of Licensor or shipped to Licensor for disposal, at Licensor's option.  Licensor will be responsible for the cost of disposal and shipping.  Any Licensee Sales Returned to Licensor will be destroyed in the manner required by the SOP of Licensee or shipped to Licensee for disposal, at Licensee's option. Licensee will be responsible for the cost of disposal and shipping.
		

		
			 
		

		
			Below is a listing of lots produced and their designation as Licensor Sales or Licensee Sales. Lots 6JO2PT, 6JO2PTA, and 6JO3PT contain both Licensor Sales and Licensee Sales and shall be designated as a "Shared Lot". All Licensor sales from the Shared Lots were made to Foundation Care. Licensee sales from Shared Lots were made to Foundation Care and additional customers. For simplicity, any returns of units from the Shared Lots from Foundation Care will be the responsibility of Licensor; returns of units from the Shared Lots from all other customers will be the responsibility of the Licensee.
		

		
			 
		

		
			Reimbursable costs of Returns will be invoiced monthly by the processing party. Payment terms shall be net thirty (30) calendar days from the date of invoice. Any undisputed past due payments over 15 days beyond due date shall bear interest at a per annum rate equal to (a) the Prime Rate plus two percent (2.0%) per annum, or the maximum interest rate permissible under law, whichever is less. All payments to be made in USD.
		

		
			 
		

		
			
		

		
			

		 

		

			2

		

 

		

			confidential

		

		

			 

		

		

		
			 
		

			
					
						Entera Health Lots

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						RedHill Lots

					
					
						 

				
	
					
						“Licensor Sales”

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 "Licensee Sales"

					
					
						 

				
	
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						6J03PTA

					
					
						 

				
	
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						6J04PT

					
					
						 

				
	
					
						3D01PT

					
					
						    

					
					
						3L02PT

					
					
						    

					
					
						5H02PTA

					
					
						    

					
					
						6B05PTA

					
					
						    

					
					
						 

					
					
						 

				
	
					
						3D01PTA

					
					
						 

					
					
						3L02PTA

					
					
						 

					
					
						5H03PT

					
					
						 

					
					
						6B06PT

					
					
						 

					
					
						And, all future Licensed Product sales up to and including the earlier of Expiration Date or Termination Date

					
					
						 

				
	
					
						3D01PTB

					
					
						 

					
					
						4M02PTA

					
					
						 

					
					
						5H03PTA

					
					
						 

					
					
						6B06PTA

					
					
						 

					
					
						 

				
	
					
						3D01PTC

					
					
						 

					
					
						4M02PTB

					
					
						 

					
					
						5H04PT

					
					
						 

					
					
						6B07PT

					
					
						 

					
					
						 

					
					
						 

				
	
					
						3E02PT

					
					
						 

					
					
						4M03PT

					
					
						 

					
					
						5H04PTA

					
					
						 

					
					
						6B07PTA

					
					
						 

					
					
						 

					
					
						 

				
	
					
						3E02PTA

					
					
						 

					
					
						4M03PTA

					
					
						 

					
					
						5K03PT

					
					
						 

					
					
						6B08PT

					
					
						 

					
					
						 

					
					
						 

				
	
					
						3E03PT

					
					
						 

					
					
						4P01PT

					
					
						 

					
					
						5K03PTA

					
					
						 

					
					
						6B08PT

					
					
						 

					
					
						 

					
					
						 

				
	
					
						3E03PTA

					
					
						 

					
					
						4P01PTA

					
					
						 

					
					
						5K04PT

					
					
						 

					
					
						6H03PT

					
					
						 

					
					
						 

					
					
						 

				
	
					
						3E04PT

					
					
						 

					
					
						4P02PTA

					
					
						 

					
					
						5K04PTA

					
					
						 

					
					
						6H03PT

					
					
						 

					
					
						 

					
					
						 

				
	
					
						3G04PT

					
					
						 

					
					
						4P02PTB

					
					
						 

					
					
						5K05PT

					
					
						 

					
					
						6H04PT

					
					
						 

					
					
						 

					
					
						 

				
	
					
						3G04PTA

					
					
						 

					
					
						5H01PT

					
					
						 

					
					
						5K05PTA

					
					
						 

					
					
						6H04PTA

					
					
						 

					
					
						 

					
					
						 

				
	
					
						3L01PT

					
					
						 

					
					
						5H01PTA

					
					
						 

					
					
						5K06PT

					
					
						 

					
					
						6J01PT

					
					
						 

					
					
						 

					
					
						 

				
	
					
						3L01PTA

					
					
						 

					
					
						5H02PT

					
					
						 

					
					
						5K06PTA

					
					
						 

					
					
						6J01PTA

					
					
						 

					
					
						 

					
					
						 

				
	
					
						3L01PTB

					
					
						 

					
					
						 

					
					
						 

					
					
						6B05PT

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						And all future Licensed Product sales after the earlier of the Expiration Date or the Termination Date

					
					
						 

				

		
			 
		

		
			 
		

		
			 
		

		 

		

			3

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