pSivida Corp. (NASDAQ:PSDV) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01. Entry into a Definitive Material Agreement.

On July10, 2017, pSivida US, Inc. (the “Company”), a wholly owned subsidiary of pSivida Corp., entered into a Second Amended and Restated Collaboration Agreement (the “New Collaboration Agreement”) with Alimera Sciences, Inc., (“Alimera”), which amended and restated the Amended and Restated Collaboration Agreement entered into between the parties on March14, 2008 (as amended to date, the “Prior Collaboration Agreement”).

Under the Prior Collaboration Agreement, the Company granted Alimera an exclusive worldwide license to manufacture, develop, market and sell ILUVIEN^® for the treatment and prevention of human eye diseases other than uveitis. ILUVIEN is marketed in the United States and in certain countries in Europe for the treatment of diabetic macular edema (“DME”). Under the New Collaboration Agreement, in addition to the rights to ILUVIEN for the treatment of DME, we also granted Alimera rights to the Company’s Durasert™ three-year treatment for posterior segment uveitis in Europe, the Middle East and Africa (the “EMEA”). The New Collaboration Agreement allows Alimera to pursue an indication for posterior segment uveitis for ILUVIEN^®in the EMEA. The Company retained commercialization rights for posterior segment uveitis in all other countries, including the United States. The New Collaboration Agreement also modified the parties’ global licensing arrangement with respect to sales of ILUVIEN for the treatment of DME.

The New Collaboration Agreement converted the Prior Collaboration Agreement’s profit sharing arrangement based on net profits from sales of ILUVIEN for the treatment of DME on a country-by-country basis to a tiered sales-based royalty arrangement based on global net revenues, effective July1, 2017. Sales-based royalty payments to the Company start at 2% and increase to 6% upon the earliest of (i)January1, 2019; (ii) Alimera’s receipt of the first European Union country marketing approval for ILUVIEN for the treatment of posterior segment uveitis; and (iii)one year from Alimera’s filing of a marketing authorization application in the European Union for posterior segment uveitis. The sales-based royalty payments will rise to 8% based on total ILUVIEN revenues in excess of $75million in any calendar year.

In connection with the New Collaboration Agreement, Alimera forgave $10million of the Company’s share of previous losses associated with the commercialization of ILUVIEN (capped at $25million under the New Collaboration Agreement), which were to be utilized to partially offset future profit sharing payments under the Prior Collaboration Agreement, and has the right to recover $15million of such previous losses as a partial offset to future royalty payments. Alimera will forgive an additional $5million of the remaining $15million of the previous losses upon approval of ILUVIEN for posterior uveitis in any European Union country or January1, 2020, whichever occurs first, unless certain conditions under the New Collaboration Agreement are not met. If the amounts recoverable by Alimera are less than $5million at that time, Alimera will pay the Company the difference in cash.

In connection with entering into the New Collaboration Agreement, the Company will withdraw its marketing approval application and orphan drug designation for posterior segment uveitis in the European Union. Going forward, Alimera will be responsible for a number of due diligence and development obligations, including filing a Type II variation for ILUVIEN for the treatment of posterior segment uveitis in the 17 countries in the European Union where ILUVIEN is currently approved for the treatment of DME.

A copy of the New Collaboration Agreement will be filed as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year ended June30, 2017. The foregoing description of the terms of the New Collaboration Agreement is qualified in its entirety by reference to the full text of such exhibit.

The press release announcing the entry into the New Collaboration Agreement is attached hereto as Exhibit 99.1, and is incorporated herein by reference.

(d) Exhibits

pSivida Corp. Exhibit
EX-99.1 2 d424247dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 pSivida Out-licenses EMEA Rights for Durasert™ Three-year Treatment for Posterior Segment Uveitis While Retaining U.S. Commercial Rights; Amended Global Collaboration Agreement with Alimera for ILUVIEN® Improves pSivida’s Revenue Generation WATERTOWN,…
To view the full exhibit click here

About pSivida Corp. (NASDAQ:PSDV)

pSivida Corp. develops drug delivery products primarily for the treatment of chronic eye diseases. The Company operates through the biotechnology sector segment. The Company has developed three products for treatment of back-of-the-eye diseases, which include Medidur for posterior segment uveitis, its lead product candidate that is in pivotal Phase III clinical trials; ILUVIEN for diabetic macular edema (DME), its lead licensed product that is sold in the United States and European Union (EU) countries, and Retisert. Medidur is designed to treat chronic non-infectious uveitis affecting the posterior segment of the eye (posterior segment uveitis). ILUVIEN is an injectable micro-insert that provides treatment of DME from a single injection. Retisert is an implant that provides treatment of posterior segment uveitis. Its product development program is focused on utilizing its two technology platforms, Durasert and Tethadur, to deliver drugs and biologics to treat chronic diseases.