Clearside Biomedical, Inc. (NASDAQ:CLSD) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01 Entry into a Material Definitive Agreement
On March 10, 2020, Clearside Biomedical, Inc. (the “Company”) entered into a License Agreement (the “License Agreement”) with Arctic Vision (Hong Kong) Limited (“Arctic Vision”). to the License Agreement, the Company has granted an exclusive license to Artic Vision to develop, distribute, promote, market and commercialize XIPERETM, the Company’s proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye using the Company’s proprietary SCS MicroinjectorTM (the “Device”), subject to specified exceptions, in China, Hong Kong, Macau, Taiwan and South Korea (the “Territory”). Under the terms of the License Agreement, neither party may commercialize XIPERE in the other party’s territory and Arctic Vision has the right, but not an obligation, to pursue development and commercialization of XIPERE for indications associated with uveitis and, upon receipt of Clearside’s consent, additional indications.
to the License Agreement, Arctic Vision has agreed to pay the Company up to a total of $35.5 million. This amount includes an upfront payment of $4.0 million as well as an aggregate of up to $31.5 million in milestone payments for specified development and regulatory milestone events, and sales milestone payments for achievement of specified levels of net sales. Further, the Company will also be entitled to receive tiered royalties of ten to twelve percent of net sales based on achieving certain annual net sales thresholds in the Territory, subject to customary reductions in specified circumstances. The royalties will be payable, on a product-by-product and country-by-country basis, on the latest of (i) the date that all valid claims within the licensed patent rights covering XIPERE have expired in the Territory, (ii) the date of the loss of marketing or regulatory exclusivity of XIPERE in the Territory, or (iii) ten years from the first commercial sale of XIPERE in the Territory.
The License Agreement will expire upon the expiration of the last-to-expire royalty term. Arctic Vision may terminate the License Agreement for convenience upon 45 days’ notice if before regulatory approval in the Territory or 90 days’ notice if after regulatory approval in the Territory. In addition, the Company can terminate the License Agreement if Arctic Vision commences a legal action challenging the validity, enforceability or scope of the licensed patents. Both parties may terminate the License Agreement (i) upon a material breach of the License Agreement, subject to a specified cure period, or (ii) if the other party enters bankruptcy. Upon termination, all licenses and other rights granted to Arctic Vision to the License Agreement would revert to the Company. If Arctic Vision exercises its termination right for convenience, or if the License Agreement terminates as a result of Arctic Vision’s material breach or bankruptcy, Arctic Vision will assign and transfer all regulatory approvals, related documents and trademarks (with respect to trademarks, only those specific to) pertaining to XIPERE in the Territory to the Company. In the event of termination as a result of material breach by or bankruptcy of the Company after regulatory approval of XIPERE in the Territory, the Company shall pay Arctic Vision royalties on net sales of XIPERE in the Territory at a low single-digit percentage rate.
The foregoing is a summary description of certain terms of the License Agreement, is not complete and is qualified in its entirety by reference to the text of the License Agreement, which the Company expects to file as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ending March 31, 2020.
About Clearside Biomedical, Inc. (NASDAQ:CLSD)
Clearside Biomedical, Inc. is a clinical biopharmaceutical company developing first-in-class drug therapies to treat blinding diseases of the eye. The Company’s product candidates focus on diseases affecting the retina, which is the tissue that lines the inside of the eye and is primarily responsible for vision, and the choroid, which is the layer adjacent to the retina that supplies the retina with blood, oxygen and nourishment. With its microinjector, drugs are injected into and spread within and through the suprachoroidal space, (SCS), which is the space located between the choroid and the outer protective layer of the eye known as the sclera. With the suprachoroidal injection, its product candidates are more directly administered to the retina and choroid as compared to other ocular drug administration techniques, such as injections of drug into the vitreous, a jelly-like substance that occupies the central portion of the eye.