KALA_Ex10_21


		
			Exhibit 10.21
		

		
			 
		

		
			EXECUTION VERSION
		

		
			 
		

		
			Confidential Materials omitted and filed separately with the
		

		
			Securities and Exchange Commission. Double asterisks denote omissions.
		

		
			 
		

		
			FIRST AMENDMENT TO THE COMMERCIAL SUPPLY AGREEMENT
		

		
			 
		

		
			This First Amendment to Commercial Supply Agreement (the “First Amendment”) is made as of  February 16,  2018 ("First Amendment Effective Date") by and between Kala Pharmaceutical Inc. a Delaware corporation with offices located at 100 Beaver Street, #201, Waltham, Massachusetts 202453 USA ("Client") and Catalent Pharma Solutions, LLC, a Delaware corporation with offices located at 14 Schoolhouse Road, Somerset, New Jersey 08873 ("Catalent").  Each of Client and Catalent may be referred to as a Party, and collectively as the Parties.
		

		
			 
		

		
			WHEREAS, the Parties entered into a Commercial  Supply Agreement dated June 27, 2016 (the "Agreement"), pursuant to which Catalent provides services to Client;  and
		

		
			 
		

		
			WHEREAS, the Parties wish to amend certain terms of the Agreement;
		

		
			 
		

		
			NOW, THEREFORE, in consideration of the mutual promises contained herein, and for good and valuable consideration, the receipt and sufficiency thereof are hereby acknowledged, the Parties do hereby agree as follows:
		

		
			 
		

			
	
			
				 1.
			

			
	
			
			All capitalized terms used herein but not otherwise defined have the same meaning as set forth in the Agreement.




		
			 
		

			
	
			
				 2.
			

			
	
			
			The Parties hereby agree to amend and replace Attachment C with the revised Attachment C, attached hereto.




		
			 
		

			
	
			
				 3.
			

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




		
			 
		

		
			IN WITNESS WHEREOF, the Parties hereto have duly executed this First Amendment as of the First Amendment Effective Date.
		

		
			 
		

			
					
						Kala Pharmaceuticals, Inc.

					
					
						    

					
					
						Catalent Pharma Solutions, LLC

				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						By:

					
					
						/s/ Vincent R. Kosewski

					
					
						 

					
					
						By:

					
					
						/s/ Roy Satchell

				
	
					
						Name:

					
					
						Vincent R. Kosewski

					
					
						 

					
					
						Name:

					
					
						Roy Satchell

				
	
					
						Title:

					
					
						Sr. VP Mfgr & Supply

					
					
						 

					
					
						Title:

					
					
						SVP R&D

				
	
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						By:

					
					
						/s/ Hongming Chen

					
					
						 

					
					
						 

					
					
						 

				
	
					
						Name:

					
					
						Hongming Chen, ScD

					
					
						 

					
					
						 

					
					
						 

				
	
					
						Title:

					
					
						Chief Scientific Officer

					
					
						 

					
					
						 

					
					
						 

				



		
			 
		

		
			
		

		
			


		 


		

			1

		





 



		

			EXECUTION VERSION

		


		

			 

		





		

		
			ATTACHMENT C
		

		
			 
		

		
			UNIT PRICING, FEES AND MINIMUM REQUIREMENT
		

		
			 
		

		
			Commercial pricing for 1st year surgical products at smaller batches:
		

		
			 
		

			
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						KPI-121,

					
					
						 

					
					
						[**]

					
					
						[**]

					
					
						[**]

				
	
					
						1% Surgical Product

					
					
						Sterile Topical Eye Drops: 3.2 mL fill in 5 cc multidose bottle in [**] L batches

					
					
						[**]

					
					
						[**]

					
					
						[**]

				
	
					
						 

					
					
						 

					
					
						[**]

					
					
						[**]

					
					
						[**]

				



		
			 
		

			
	
			
				 ·
			

			
	
			
			[**] batches per campaign




			
	
			
				 ·
			

			
	
			
			No split batches at the [**]L scale, batch can be run to fill either trade or physician samples




		
			 
		

			
					
						Commercial Unit Pricing after scale up

				
	
					
						Product

					
					
						Dosage Form / Unit Strength

					
					
						Annual Unit Tiers

					
					
						Bulk Price

					
					
						Fully

				
	
					
						Packaged1

				
	
					
						KPI-121,

					
					
						Sterile Topical Eye Drops: 3.2 mL fill in 5 cc multidose bottle in [**] L batches

					
					
						[**]

					
					
						[**]

					
					
						[**]

				
	
					
						1% Surgical Product

					
					
						[**]

					
					
						[**]

					
					
						[**]

				
	
					
						 

					
					
						[**]

					
					
						[**]

					
					
						[**]

				
	
					
						KPI-121, 0.25% Dry Eyes Product

					
					
						Sterile Topical Eye drops/8.2 mL fill in a

					
					
						[**]

					
					
						[**]

					
					
						[**]

				
	
					
						 

					
					
						10 cc multidose bottle in [**]L Batches

					
					
						[**]

					
					
						[**]

					
					
						[**]

				
	
					
						 

					
					
						 

					
					
						[**]

					
					
						[**]

					
					
						[**]

				



		
			 
		

		
			
		

		
			


		 


		

			2

		





 



		

			EXECUTION VERSION

		


		

			 

		





		

			
	
			
				 ·
			

			
	
			
			Minimum yield criteria will not apply at this scale




			
	
			
				 ·
			

			
	
			
			Development of scaled-up process, and scaled up PV batches, will be conducted by 1 year after small scale PV batches are completed




		
			 
		

			
					
						Sublotting for finished Products

				
	
					
						Product

					
					
						Sublotting Samples2

					
					
						Sublotting
Fee/Batch

					
					
						Bulk Price

					
					
						Fully
Packaged1

				
	
					
						KPI-121, 1% Surgical
Product

					
					
						Sterile Topical eye drops -
Sample -11.5 mL in 5 cc
multidose bottle

					
					
						[**]

					
					
						[**]

				
	
					
						KPI-121, 0.25% Dry Eyes
Product

					
					
						Sterile Topical Eye drops -
Sample - 2.7mL in a 10ml cc
multidose bottle

				



		
			1 Packaging will consist of wrap around label, individual carton and insert
		

		
			2 The minimum for a sublotted batch will be [**] percent ([**]%) of total units in a Batch.
		

			
	
			
				 ·
			

			
	
			
			One unit (“Unit”) is one multi-dose bottle of 5cc or 10cc containing 1.5ml, 2.7ml, 3.2 mL or 8.2mL of Product.




			
	
			
				 ·
			

			
	
			
			[**].




		
			 
		

			
					
						MINIMUM REQUIREMENT

				
	
					
						Minimum Requirement Year

					
					
						Aggregate Product Minimum Requirement

				
	
					
						 

					
					
						1% Surgical Product, Units (MM)

					
					
						0.25% Dry Eyes Product, Units (MM)

				
	
					
						Minimum Requirement Year 1*

					
					
						[**]

					
					
						[**]

				
	
					
						Minimum Requirement Year 2

					
					
						[**]

					
					
						[**]

				
	
					
						Minimum Requirement Year 3

					
					
						[**]

					
					
						[**]

				
	
					
						Minimum Requirement Year 4

					
					
						[**]

					
					
						[**]

				
	
					
						Minimum Requirement Year 5

					
					
						[**]

					
					
						[**]

				
	
					
						Minimum Requirement Year 6

					
					
						[**]

					
					
						[**]

				
	
					
						Minimum Requirement Year 7

					
					
						[**]

					
					
						[**]

				
	
					
						Minimum Requirement Year 8

					
					
						[**]

					
					
						[**]

				



		
			*Any Units purchased by Client for resale shall count towards the Minimum Requirement, even if purchased by Client prior to Minimum Requirement Year 1.
		


		 


		

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