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SEC Filings
10-Q
OMEROS CORP filed this Form 10-Q on 11/09/2015
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Assuming Fagron complies with its obligations under the OMS103 Agreement, Fagron may fail to commercialize OMS103 successfully for a number of reasons, including:
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a lack of acceptance by physicians, patients, third-party payers and other members of the medical community, including based on any conclusion that may be reached regarding the efficacy or lack of efficacy of OMS103;
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pricing, reimbursement and coverage policies of government and private payers such as Medicare, Medicaid, the VA, group purchasing organizations, insurance companies, health maintenance organizations and other plan administrators;
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the availability, relative price and efficacy of OMS103 as compared to alternative treatment options or competing products;
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an unknown safety risk of OMS103;
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failure to comply with applicable regulatory requirements;
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failure to comply with applicable cGMPs;
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changed or increased regulatory restrictions in the U.S.; and
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a lack of adequate financial or other resources by Fagron to commercialize the product successfully.
We and Fagron are in discussions concerning timing of the initiation of sales under the OMS103 Agreement. If Fagron fails to perform its obligations under the OMS103 Agreement in a timely manner it would adversely affect the likelihood and timing of our receipt of royalty or milestone payments from Fagron under the OMS103 Agreement. Further, if the OMS103 Agreement is terminated, we can provide no assurances that we will be able to enter into another licensing agreement or have sufficient resources to restart clinical development and conduct any clinical trials if desired. Any of the above risks, if realized, could adversely affect our results of operations.
Under Section 503B of the FDCA, registered outsourcing facilities are required to manufacture under GMP and are subject to FDA inspections and audits. They also are not allowed to manufacture a product that is essentially a copy of one or more FDA-approved drugs. If Fagron is prohibited from commercializing or from continuing commercial sales of OMS103 following initial commercialization because of violations of any FDA regulations or any other reason, our ability to generate revenue from royalty payments from Fagron and achieve profitability will be adversely affected and the market price of our common stock could decline.
Belangrijkste stuk:If Fagron fails to perform its obligations under the OMS103 Agreement in a timely manner it would adversely affect the likelihood and timing of our receipt of royalty or milestone payments from Fagron under the OMS103 Agreement. Men geeft dus zelf aan dat potentiele payments direct gerelateerd zijn aan de bovengenoemde voorwaarden, en alleen als Fagron kan gaan produceren en verkopen zij aanspraak kunnen maken op bepaalde betalingen.