ALIMERA SCIENCES, INC. (NASDAQ:ALIM) Files An 8-K Entry into a Material Definitive Agreement

ALIMERA SCIENCES, INC. (NASDAQ:ALIM) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01. Entry into a Definitive Material Agreement.

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On July 10, 2017, Alimera Sciences, Inc. (the “Company”) announced that it had entered into a Second Amended and Restated Collaboration Agreement (the “New Collaboration Agreement”) with pSivida US, Inc. (“pSivida”), which amends and restates the Amended and Restated Collaboration Agreement entered into between the parties on March 14, 2008 (as amended to date, the “Prior Collaboration Agreement”).

Under the Prior Collaboration Agreement, the Company held the worldwide license from pSivida to sell ILUVIEN® for the treatment of all ocular diseases other than uveitis. The New Collaboration Agreement allows the Company to also pursue an indication for posterior uveitis for ILUVIEN in the European Union (EU), the Middle East and Africa.

The New Collaboration Agreement converts the Company’s obligation to share 20% of its net profits from ILUVIEN on a country-by-country basis with pSivida to a royalty payable by the Company to pSivida on global net revenues. The Company will begin paying a 2% royalty on net revenues and other related consideration to pSivida beginning in the third quarter of 2017. This royalty amount will increase to 6% upon the earliest of January 1, 2019, the receipt by the Company of the first marketing approval for ILUVIEN for the treatment of posterior uveitis, or one year from the Company’s filing of a marketing authorization application in the EU for posterior uveitis. The Company will pay an additional 2% royalty on global net revenues and other related consideration in excess of $75 million in any year.

The New Collaboration Agreement does not require an upfront cash payment by the Company. In connection with the New Collaboration Agreement, the Company has agreed to forgive approximately $10 million of pSivida’s share of previous losses associated with the commercialization of ILUVIEN, which were to be utilized to partially offset future profit sharing payments under the Prior Collaboration Agreement. Following the signing of the New Collaboration Agreement, the Company retains a right to recover an additional $15 million of pSivida’s share of the previous losses as a partial offset to future royalty payments following approval. These amounts were fully reserved on the Company's financial statements.

The Company will forgive an additional $5 million of pSivida’s outstanding share of previous losses upon the earlier of the approval of ILUVIEN for posterior uveitis in any EU country or January 1, 2020, unless certain conditions under the New Collaboration Agreement are not met. If the amounts recoverable by the Company are less than $5 million at that time, the Company will pay pSivida the difference in cash.

The Company is subject to customary due diligence obligations and other terms and conditions under the New Collaboration Agreement.

A copy of the New Collaboration Agreement will be filed as an exhibit to the Company’s Form 10-Q for the quarter ending September 30, 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 furnished as Exhibit 99.1 to this current report on Form 8-K.

Item 1.01.Financial Statements and Exhibits.

(d)Exhibits

ExhibitNo.

Description

99.1

Press Release of Alimera Sciences, Inc., dated July 10, 2017


ALIMERA SCIENCES INC Exhibit
EX-99.1 2 pr.htm EXHIBIT 99.1 Exhibit Exhibit 99.1FOR IMMEDIATE RELEASEFor press inquiries:For investor inquiries:Katie BrazelCG Capitalfor Alimera Sciencesfor Alimera Sciences404-317-8361877-889-1972kbrazel@[email protected] SCIENCES TO EXPAND ILUVIEN® INDICATION IN EUROPE FOR POSTERIOR UVEITISSigns license agreement with pSivida for posterior uveitis in Europe,…
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About ALIMERA SCIENCES, INC. (NASDAQ:ALIM)

Alimera Sciences, Inc. (Alimera) is a pharmaceutical company. The Company is engaged in the research, development and commercialization of prescription ophthalmic pharmaceuticals. The Company operates through two segments: U.S. and International. The Company focuses on diseases affecting the back of the eye or retina. The Company’s product is ILUVIEN, which is developed to treat diabetic macular edema (DME). DME is a disease of the retina that affects individuals with diabetes and can lead to severe vision loss and blindness. In the United States, ILUVIEN is indicated for the treatment of DME in patients who have been treated with a course of corticosteroids and did not have a rise in intraocular pressure (IOP). In the European Economic Area (EEA) countries, ILUVIEN is indicated for the treatment of vision impairment associated with DME considered insufficiently responsive to available therapies.

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