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AMENDMENT NO. 1 TO
COMMERCIAL SUPPLY AGREEMENT
This Amendment No. 1 (the Amendment) to the Commercial Supply Agreement by and between Horizon Pharma Ireland Limited (Customer) and AGC Biologics A/S, formerly known as CMC Biologics A/S (AGC) is dated as of May 15, 2019 (Amendment Effective Date).
AGC and Customer are Parties to the Commercial Supply Agreement effective as of February 14, 2018 (the Agreement). AGC and Customer wish to amend certain provisions of the Agreement so that AGC may subcontract certain Services to AGCs affiliated entity, AGC Biologics, Inc., located in Bothell, Washington (AGC SEA).
1. Definition and Interpretation. The definition of AGC Facility in Clause 1.1 of the Agreement is deleted in its entirety and replaced by the following:
AGC Facility means AGCs manufacturing facility in Copenhagen, Denmark, Bothell, Washington or another AGC facility agreed on in writing by the Parties.
2. Quality Agreement. The following provision is added to the end of Clause 2.3:
Promptly following the Amendment Effective Date, but in any event within [***] days following the Amendment Effective Date unless mutually extended by the Parties, AGC and Customer shall execute an addendum to the Commercial Quality Agreement or enter into a new Quality Agreement to address the manufacture of Product by AGC SEA.
3. Subcontract to Affiliates. Clause 2.5.1 is deleted in its entirety and replaced with the following:
2.5 AGC may subcontract
2.5.1 to its Affiliates, specifically AGC SEA, any part of the Services (provided that the Affiliates may not further subcontract those parts of the Services), with the prior written consent of Customer (such consent not to be unreasonably withheld, delayed or conditioned);
4. Subcontract to Testing Laboratories. Pursuant to Clause 2.5.2 of the Agreement, Customer acknowledges and agrees that AGC SEA may subcontract the Services identified in the definition of Testing Laboratories to the parties identified as Contract Labs on Attachment C to the Commercial Quality Agreement.
5. Customer Materials; AGC Materials. Clause 3.1 of the Agreement is deleted in its entirety and replaced with the following:
All Raw Materials purchased by AGC for the Services will be the property of AGC. Customer will reimburse AGC for any Raw Materials purchased and consumed by AGC for manufacture of Product. Payments made by Customer to reimburse AGC for Raw Materials purchased for the Services shall be
[***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED