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YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. no assurances that we will be able to obtain orphan designations for FYARRO in additional indications or for any future product candidates. In the United States, orphan drug designation entitles a ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. period can be reduced to six years if a drug no longer meets the criteria for orphan drug designation or if the drug is sufficiently profitable so that market exclusivity is no longer justified. In...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. apply its longstanding interpretation of the regulations to matters outside of the scope of the Catalyst order – that is, the agency will continue tying the scope of orphan-drug exclusivity to the...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. obtained orphan drug designation for the orphan-designated indication due to the uncertainties associated with developing pharmaceutical products. In addition, exclusive marketing rights in the Uni...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. same condition if the FDA concludes that the later drug is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care or the manufacturer of th...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. commercialize FYARRO for such orphan population due to risks that include: the orphan patient populations may change in size; there may be changes in the treatment options for patients that may pr...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. other orphan population for which we obtain orphan drug designation or we are unable to successfully commercialize FYARRO for such orphan population, it could harm our business prospects, financial ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. to pursue accelerated development strategies in areas of high unmet need. We may seek an accelerated approval pathway for future product candidates. Under the accelerated approval provisions in the ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. An intermediate clinical endpoint is a clinical endpoint that can be measured earlier th...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. FDA may withdraw its approval of the drug. In addition, the FDA currently requires as a condition for accelerated approval pre-ap proval of promotional materials, which could adversely impact the t...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. approval requirements. In March 2023, FDA issued a draft guidance on clinical trial considerations for supporting accelerated approval of oncology therapeutics, noting that although single-arm trial...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. or submit an NDA for accelerated approval or any other form of expedited development, review or approval. Similarly, there can be no assurance that after subsequent FDA feedback we will continue to ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. failure to obtain accelerated approval or any other form of expedited development, review or approval for a product candidate would result in a longer time period to commercialization of such produc...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. or abroad. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. other challengers had no legal standing to challenge the ACA, dismissing the case without specifically ruling on the constitutionality of the ACA. Moreover, there has been heightened governmental sc...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. in rebates than it receives on the sale of products, which could have a material impact on our business. Further, in July 2021, the Biden administration released an executive order, “Promoting Compe...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. excise tax for manufacturers that fail to comply with the drug price negotiation requirements, requiring inflation rebates for all Medicare Part B and Part D drugs, with limited exceptions, if their...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. our business. 64 Table of Contents In addition, other legislative changes have been proposed and adopted in the United States since the ACA was enacted. These changes included aggregate reduction...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. to 2% for FY 2030 and 2031. In January 2013, former President Obama signed into law the American Taxpayer Relief Act of 2012, which, among other things, reduced Medicare payments to several provider...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. For example, a numb...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. and Matthew Bellina Right to Try Act of 2017 (“Right to Try Act”), was signed into law. The law, among other things, provides a federal framework for certain patients to access certain investigation...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. any approved product. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation of cost containm...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. stringent product labeling and post-marketing testing and other requirements. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or a...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. certain conditions and imposes substantial obligations upon companies and new rights for individuals. Failure to comply with the GDPR and the applicable national data protection laws of the European...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. the privacy and security of information we maintain, and may differ from each other in significant ways, thus complicating compliance efforts. For example, the California Consumer Privacy Act of 201...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. While it exempts some data regulated by the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and certain clinical trials data, the CCPA, to the extent applicable to our business...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. performing normal business functions on which the operation of our business may rely, which could negatively impact our business. The ability of the FDA to review and approve new products can be af...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , may also slow the time necessary for new product candidates to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, in recent years,...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. oresearch monitoring and pre-approval inspections on a prioritized basis. While the FDA has largely caught up with domestic preapproval inspections, it continues to work through its backlog of foreig...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , transparency laws, government price reporting, and health information privacy and security laws, which could expose us to significant losses, including, among other things, criminal sanctions, civi...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. healthcare laws and regulations may include the following: the federal Anti-Kickback Statute prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, r...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. uneration involved, imprisonment, and exclusion from government healthcare programs. In addition, the government may assert that a claim including items or services resulting from a violation of the ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. held liable under the federal False Claims Act even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims. The feder...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. receive items or services reimbursable by the government from a particular provider or supplier; the FCPA, the U.K. Bribery Act of 2010, and other local anti-corruption laws that apply to our inter...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. or making any materially false, fictitious, or fraudulent statements or representations in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthc...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. maintenance, receipt, use, or disclosure of, individually identifiable health information relating to the privacy, security and transmission of individually identifiable health information. HITECH a...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. Act requires applicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, wi...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. additionally, we are subject to state and foreign equivalents of each of the healthcare laws and regulations described above, among others, some of which may be broader in scope and may apply regardl...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. Code on Interactions with Healthcare Professionals. Several states also impose other marketing restrictions or require pharmaceutical companies to make marketing or price disclosures to the state an...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. each other in significant ways and often are not preempted by HIPAA, thus complicating compliance effort. Because of the breadth of these laws and the narrowness of available statutory and regulato...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. organization or rely on distributors outside of the United States, we would be at increased risk of violating these laws or our internal policies and procedures. The risk of us being found in violat...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regula...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. require significant financial and personnel resources. Therefore, even if we are successful in defending against any such actions that may be brought against us, our business may be impaired. Furthe...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. fraud, misconduct or other improper activities. Misconduct by these parties could include intentional, reckless, and negligent conduct that fails to: comply with the regulations of the FDA and other...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , marketing and promotion, sales commission, certain customer incentive programs and other business arrangements. Misconduct by these parties could also involve the improper use of information obtain...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. a significant impact on our business, including the imposition of significant penalties, including civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , the generation, handling, use, storage, treatment and disposal of hazardous and regulated materials and wastes, the emission and discharge of hazardous materials into the ground, air, and water; an...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. with civil or criminal fines and penalties. Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. subject to the FCPA and similar anti-bribery and anti-corruption laws of other countries. Compliance with these legal requirements could limit our ability to compete in foreign markets and subject u...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. and records that accurately and fairly reflect the transactions of the corporation and to devise and maintain an adequate system of internal accounting controls. Our business is heavily regulated an...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , or contractors, or those of our affiliates, will comply with all applicable laws and regulations, particularly given the high level of complexity of these laws. Violations of these laws and regulat...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. may be subject to United States and certain foreign export controls, trade sanctions, and import laws and regulations. Compliance with these legal requirements could limit our ability to compete in ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , United States export control laws and economic sanctions prohibit the shipment of certain products and services to countries, governments, and persons targeted by United States sanctions. For examp...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. or shifting approaches in the enforcement or scope of existing regulations, or in the countries, persons, or products targeted by such regulations, could result in decreased use of our products by, ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , such as a deterioration in the relationship between the United States and China or escalation in conflict between Russia and Ukraine, including any additional sanctions, export controls or other re...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. of FYARRO for commercialization and expect to continue to do so for additional clinical trials. This reliance on third parties, some of which are sole source suppliers, increases the risk that we wi...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. case of FYARRO, we rely on a single third-party manufacturer, Fresenius Kabi, LLC (“Fresenius Kabi”), and currently have n o alternative manufacturer in place. On January 13, 2022, we entered into ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. through March 31, 2024 (or such later date as may be agreed between the parties in writing), and we may purchase FYARRO for either clinical or commercial purposes for use in the United States and Ca...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. engage another third-party manufacturer, we will be required to verify that the new third-party manufacturer maintains facilities and procedures that comply with quality standards and with all appli...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. or be required to restart or repeat, any pending or ongoing clinical trials for FYARRO in other indications or for any other product candidates we may develop in 70 Table of Contents the future, ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. . Even if we are able to establish agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including: the failure of the third party to manufacture...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. supply pursuant to strictly enforced cGMPs; the failure of the third-party contractor to manufacture FYARRO or any of our other product candidates that we may develop in the future according to our...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. regulations for manufacturing both active pharmaceutical ingredients (“API”) and finished drug products. To date, we have obtained drug substance and drug product from third-party manufacturers to s...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. able to comply with cGMP regulations or similar regulatory requirements outside of the United States. If our CMOs cannot successfully manufacture material that conforms to our specifications and the...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. products may affect the regulatory clearance of our CMOs facilities generally. If the FDA, EMA or a comparable foreign regulatory authority does not approve these facilities for the manufacture of F...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. exposes us to the possibility that they, or third parties with access to their facilities, will have access to and may appropriate our trade secrets or other proprietary information. Our failure, or...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , including the development of advanced manufacturing techniques and process controls. Manufacturers of pharmaceutical products often encounter difficulties in production, particularly in scaling up ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. trials towards approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods, are altered along the way in an effort to optimize process...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. availability or cost of materials, which could disrupt the supply chain for FYARRO or any of our product candidates that we may develop in the future. Further, our manufacturers may experience manuf...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. require bridging clinical trials or the repetition of one or more clinical trials, increase clinical study costs, delay approval of our product candidate, impair commercialization efforts, increase ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. a single-source supplier, Fresenius K abi, for our drug product FYARRO. In January 2022, we entered into the Fresenius Agreement, which we amended in January 2023 to, among other things, extend the...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. continue the manufacturing or supply of FYARRO at any time. We do not carry a significant inventory of FYARRO or our key raw materials used in the manufacture of FYARRO. Our suppliers may not be able...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. the Fresenius Agreement or loss of manufacturing ability by such manufacturer could similarly require significant time, effort and expense to locate and qualify an alternative source of manufacturin...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. not currently have arrangements in place for redundant supply of the drug product FYARRO or for the key raw materials used in the manufacture of FYARRO. 72 Table of Contents Establishing addition...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. alternate sources of supply for the drug product FYARRO or for the key raw materials used in the manufacture of FYARRO, we will not be able to, or may be delayed in our efforts to, successfully comm...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , if approved, could be delayed or prevented. Manufacturing drugs, especially in large quantities, is complex and highly regulated and may require the use of innovative technologies. Each lot of an ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. spoilage. When changes are made to the manufacturing process, we may be required to provide preclinical and clinical data showing the comparable identity, strength, quality, purity or efficacy of th...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. growth prospects. We depend on intellectual property licensed from third parties and termination of any of these licenses could result in the loss of significant rights, which would harm our busine...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. fees and certain other fees. We may not meet these requirements, which could result in a loss or termination of any rights under such agreements. Any termination of these licenses will result in the...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. to meet deadlines for the completion of such trials, research and studies. We do not have the ability to independently conduct all of our preclinical studies and clinical trials. We currently rely ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. employees, and except for remedies available to us under our agreements with such third parties, we have limited ability to control the conduct of such third party, the 73 Table of Contents amoun...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. be our competitors, which may draw time and resources from our development programs. The third parties with whom we may contract might not be diligent, careful or timely in conducting our preclinica...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. regulatory, and scientific requirements and standards. Moreover, the FDA requires us and our third parties to comply with applicable GLP and GCP standards, regulations for conducting, monitoring, re...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. unreliable and the FDA, EMA or comparable foreign regulatory authorities may require us to perform additional preclinical studies or clinical trials before approving our marketing applications. We c...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. certain completed clinical trials on a government-sponsored database, ClinicalTrials.gov, within certain timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sa...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. . We may form or seek strategic alliances or collaborations in the future. Such alliances and collaborations may inhibit future opportunities, or we may not realize the benefits of such collaboratio...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. and products, either on their own or in partnership with others; our collaboration partners may terminate their collaboration with us, which could make it difficult for us to attract new partners o...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. 74 Table of Contents or royalties under those collaborations. In addition, we may be required to devote additional resources to the development of our product candidates or seek a new collaboration...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. addition, EOC was responsible for development, regulatory submissions, and commercialization in China, Hong Kong, Macau and Taiwan (collectively, the EOC Territory ). The EOC License Agreement wa...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. revenue from the licensed product in the EOC Territory and we will not receive future revenues from the collaboration. It may be necessary for us to assume the responsibility at our own expense for...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. ute our existing stockholders or disrupt our management and business. In addition, we face significant competition in seeking appropriate strategic partners, and the negotiation process is time-consu...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. From time to time, we evaluate various acquisition opportunities and strategic partnerships, including licensing or acquiring complementary products, intellectual property rights, technologies, or bu...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. existing products or product candidates and regulatory approvals; and our inability to generate revenue from acquired technology and/or products sufficient to meet our objectives in undertaking the...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. expand our capabilities, potentially accelerate research and development activities and provide for commercialization activities by third parties. Any of these relationships may require us to incur ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. authorities, the potential market for the subject product candidate, the costs and complexities of manufacturing and delivering such product candidate to patients, the potential of competing drugs, ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. of recent business combinations among large pharmaceutical companies that have resulted in a reduced number of potential future collaborators. Even if we are successful in entering into a collaborat...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. to increase our expenditures to fund development or commercialization activities on our own, we may need to obtain additional capital, which may not be available to us on acceptable terms or at all....
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. depend on our collaborators’ abilities and efforts to successfully perform the functions assigned to them in these arrangements. Collaborations involving our product candidates would pose numerous r...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a produ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. from collaborating with others; collaborators may not properly obtain, maintain, defend or enforce our intellectual property rights or may use our proprietary information and intellectual property ...