[***] = CONFIDENTIAL TREATMENT REQUESTED
Cedarburg Hauser Pharmaceuticals
CONFIDENTIAL
Cedarburg Hauser will prepare, file and maintain, throughout the Supply Term, the drug master file (“DMF”) to support the commercial sale of Riboflavin 5’ Phosphate Sodium. Cedarburg will maintain ownership of this filing and will provide the appropriate documentation to Avedro, Inc. upon request. Except as expressly set forth herein, Avedro shall be responsible for all other filings necessary for regulatory approval of the Materials or any product comprising the Materials. Cedarburg agrees to use its best efforts to assist Avedro in obtaining such regulatory approvals throughout the world. Cedarburg specifically agrees to cooperate with any inspection by the FDA or other regulatory agency, including but not limited to any inspection prior to any such regulatory approval.
Cedarburg Hauser will perform a [***] stability study on the first commercial batch of API released in a calendar year and will provide updated COA”s for material as appropriate / necessary.
3.0 | Pricing and Payment Terms |
Cedarburg Hauser will offer commercial Riboflavin 5’ Phosphate Sodium at a price of $[***] per [***] grams (the “Price”), [***].
Payments toward all undisputed invoices are due within [***] of receipt of invoice and arenon-refundable. Invoices will be issued upon shipment of approved material.
Delivery of Material [***] will occur within [***] of receipt of purchase order by Cedarburg, pending confirmation of available capacity at Cedarburg, to the delivery destination designated by Avedro in the applicable purchase order. Upon confirmation of production capacity, Cedarburg will inform Avedro of the projected delivery date for ordered ABI materials. Notwithstanding the reference to “[***]” in Section 5(a)(15) of the MSA, Cedarburg will ship all Materials [***] hereunder.
5.0 | No Use of Process for Third Parties |
Cedarburg acknowledges and agrees that, in accordance with the MSA, Avedro owns the validated process for manufacture of Riboflavin 5’ Phosphate Sodium developed for Avedro under [***] and any subsequent improvements to the process (including scale up) that are developed under this Agreement or otherwise funded by Avedro. Cedarburg is not permitted, and shall not, directly or indirectly, disclose the foregoing to any third party, and/or use or permit the use of the foregoing, for itself or by or on behalf of any third party.
The parties shall negotiate and enter into a comprehensive quality agreement that governs the quality control of the Materials supplied under this Agreement (the “Quality Agreement”), which, once effective, shall govern the quality aspects of the manufacture and supply of Materials hereunder. [
With respect to Cedarburg’s insurance requirements pursuant to Section 6(d) of the MSA, for purposes of this Supply Agreement, the reference to “[***], in the aggregate” shall be deleted and replaced with “[***] in the aggregate.”
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870 Badger Circle, Grafton, WI 53024 262-376-1467 CedarburgHauser.com | | Page 4 of 5 |