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Drug manufacturers and other entities involved in the manufacture and distribution of approved drugs are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and some state agencies for compliance with cGMP and other laws.

        Any immune response that causes adverse reactions or impairs the activity of the drug could cause a delay in or termination of our development of zilucoplan, which would have a material adverse effect on our financial condition and results of operation.

Under the terms of the Samil Agreement, the Company received an up-front payment of approximately $2.1 million. Samil has also agreed to pay additional clinical and regulatory-based milestone payments, which may aggregate up to $6.0 million, as well as tiered, double-digit royalties payable on sales (under certain limitations). In September, 2018 the Company received a milestone payment of $1.5 million from Samil in connection with the completion of its ARREST study.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Set forth below is information concerning the directors, senior management and executive officers of the Company as of February 28, 2019, the latest practicable date for inclusion in this annual report. The business address for each of our directors, senior management and corporate officers is c/o Galmed Pharmaceuticals Ltd., 16 Tiomkin St., Tel Aviv 6578317, Israel.

Marshall Heinberg. Prior to joining our Board in October 2018, Mr. Heinberg provided consulting services to us through MAH Associates, LLC, or MAH since 2013. During 2018, we paid MAH aggregate consulting fees of $167,520 up to the time he joined the Board.

Sysa-Shah, P. et al. Cardiac-specific over-expression of epidermal growth factor receptor 2 (ErbB2) induces pro-survival pathways and hypertrophic cardiomyopathy in mice. PLoS ONE 7, e42805, 10.1371/journal.pone.0042805 (2012).

Derma Sciences, Inc. (NasdaqCM:DSCI) is a medical technology company focused on three segments of the wound care marketplace, traditional dressings, advanced wound care dressings and pharmaceutical wound care products. Its MEDIHONEY® product is the leading brand of honey-based dressings for the management of wounds and burns. The product has been shown to be effective in a variety of indications, and was the focus of a positive large-scale, randomized controlled trial involving 108 patients with leg ulcers. Other novel products introduced into the $14 billion global wound care market include XTRASORB® for better management of wound exudates, and BIOGUARD® for infection prevention. As noted above, Derma Sciences expects to complete the efficacy portion of its Phase 2 clinical study with DSC127, a novel pharmaceutical for accelerated wound healing and scar reduction, by the end of 2010.

Ozurdex (dexamethasone intravitreal implant) is the first PLG extended-release implant administered to the eye using a specifically designed applicator. The PLG implant releases 700 µg of dexamethasone for one month to treat macular edema and uveitis.

Use of third parties to manufacture our product candidates may increase the risk that we will not have sufficient quantities of our product candidates, products, or necessary quantities at an acceptable cost.

Our Board has adopted a nominating committee charter setting forth the responsibilities of the nominating committee consistent with the Nasdaq Listing Rules.