Amendment No. 1 to Commercial Supply Agreement, dated February 16, 2018, by and between the Registrant and Catalent Pharma Solutions, LLC

EX-10.21 5 kala-20171231ex10217aa89.htm EX-10.21 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

 

 

 

 

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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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