Motus has the worldwide rights to RM-131 (relamorelin), a peptide ghrelin agonist being developed for the treatment of diabetic gastroparesis. Search / Go.
However, limited progress to date in these negotiations and ongoing uncertainty within the UK Government and Parliament increases the possibility of the United Kingdom leaving the European Union on March 29, 2019 without a withdrawal agreement and associated transition period in place, which is likely to cause significant market and economic disruption. Federal, state, local and foreign laws of general applicability, such as laws regulating working conditions, also govern us. These and other risks could have a material adverse effect on our business, results of operations, financial condition and cash flows.
Refer to ITEM1A. The manufacture of our products and product candidates requires precise manufacturing process controls, API that conforms to very tight tolerances for specific characteristics and equipment that operates consistently within narrow performance ranges.
our employees, customers, partners and others to protect our proprietary rights.
We are subject to the periodic inspection of our facilities, procedures and operations and/or the testing of our products by the FDA, the DEA and other health authorities, which conduct periodic inspections to assess compliance with applicable regulations.
/Producer ( Q t 5 . We also rely on trade secrets and proprietary know-how that we seek to protect, in part, through confidentiality agreements with our partners, customers, employees and consultants. However, this control deficiency could have resulted in a misstatement to the income tax accounts and disclosures, which would have resulted in a material misstatement to the annual or interim consolidated financial statements that would not be prevented or detected. Once approved, the NDA is subject to life-cycle management regulations (for example, annual reports) in order to maintain product registrations.
Annual Report on Form 10-K is equally applicable to Allergan plc and Warner Chilcott Limited, except where otherwise indicated. However, we may not be able to discover or determine the extent of any unauthorized use of our proprietary rights, and we may not be able to prevent third parties from misappropriating or infringing upon our proprietary rights.
Within the Investors section of our website, we provide information concerning corporate governance, including our Corporate Governance Guidelines, Board Committee Charters and Composition, Code of Conduct and other information.
fluctuations in foreign currency exchange rates.
Eligible recipients include seniors, persons on social assistance, low-income earners, and those with certain specified conditions or diseases. The branded manufacturer who brought the action, may also renounce application of the 24-month period but this could allow for early market entry, subject to data protection and the generic applicants willingness to launch at risk. Pursuant to the agreement, Allergan made an upfront payment of $90.0 million for the right to license up to five of Editas gene-editing programs in eye care, including its lead program for Leber Congenital Amaurosis (LCA). Canada is further involved in trade negotiations with ten Pacific countries (the Comprehensive and Progressive Agreement for Trans-Pacific Partnership), which could lead to further changes to Canadas intellectual property framework and affect our business.
We are a visionary immunology business with specialist experience in the research and development of allergy treatments. and the future milestones will be recorded if the corresponding events become probable. On April 6, 2018, the Company completed the acquisition of Elastagen Pty Ltd, a clinical stage medical company developing medical and cosmetic treatments including recombinant human tropoelastin, the precursor of elastin,which will be combined with Allergan's existing fillers product lines. In some states, supplemental rebates are required as a condition of including the manufacturers drug on a states Preferred Drug List, which if agreed upon would generally permit access to a manufacturers product without utilization management (e.g., step therapy). These laws apply to our uses of personal data, transfers of information among our affiliates, as well as to transactions we enter into with third party vendors.
Regulatory authorities in the EU may conduct inspections of the manufacturing facilities to review procedures, operating systems and personnel qualifications. The U.S. federal government began a partial government shut down due to a lapse in appropriations on December 22, 2018, which continued until January 25, 2019. The reduction or elimination of our cash dividend could adversely affect the market price of our ordinary shares.
On June 23, 2017, the Company acquired Keller Medical, Inc. (Keller), a privately held medical device company and developer of the Keller Funnel
Our competitors include the major brand name manufacturers of pharmaceutical products. Our US General Medicine business is focused on newly developed pharmaceutical products, which are normally patented or have market exclusivity. Our environmental capital expenditures and costs for environmental compliance may increase in the future as a result of changes in environmental laws and regulations or increased manufacturing activities at any of our facilities. If there is a future lapse in appropriation or similar government shutdown the FDA may be unable to accept new regulatory submissions, including NDAs. These individual regulatory bodies can result in considerable price differences and product availability among member states. The lengthy process of clinical development and submissions for clearance or approval, and the continuing need for compliance with applicable laws and regulations, require the expenditure of substantial resources. As part of theTevaTransaction,Tevaacquiredour global generics business, including the United States (U.S.) and international generic commercial units, our third-party supplierMedis, our global generic manufacturing operations, our global generic research and development (R&D) unit, our international over-the-counter (OTC) commercial unit (excluding OTC eye care products) and certain established international brands. Negative publicity, whether accurate or inaccurate, about the efficacy, safety or side effects of our products or product categories, whether involving us or a competitor, could materially reduce market acceptance to our products, cause consumers to seek alternatives to our products, result in product withdrawals and cause our stock price to decline. comply with such laws and regulations that would have a material impact on our earnings or competitive position.
As a result of the differences between the types of products we market and/or distribute, we operate and manage our business in three distinct operating segments: US Specialized Therapeutics, US General Medicine and International. The total upfront net payment of $59.7 million was included as a component of R&D expense
The results of preclinical studies and early clinical studies may not be predictive of the results of laterstage clinical studies. Under the terms of the Motus Transaction, Motus shareholders are eligible to receive contingent consideration in connection with the commercial launch of the product. No other countries outside the U.S. and Canada had 10% or more of global sales.
The loss of any of these customers could have a material adverse effect on our business, results of operations, financial condition and cash flows. References throughout to we, our, us, the Company or Allergan refer to financial information and transactions of Watson Pharmaceuticals, Inc. prior to January 23, 2013, Allergan Finance, LLC from January 23, 2013 until October1, 2013 and Allergan plc and Warner Chilcott Limited subsequent to October1, 2013. The LifeCell Acquisition combined LifeCell's novel, regenerative medicines business, including its high-quality and durable portfolio of dermal matrix products, with the Companys leading portfolio of medical aesthetic products, breast implants and tissue expanders. That assessment could change based on competitive or commercial developments (which could, for example, increase our need for capital expenditures), new growth opportunities, the terms of future debt instruments, legal risks, changes in Irish corporate or tax or federal tax law and challenges to our business model. product entered the market in December 2018. Global pioneers of convenient treatment for allergy and immune related disorders.
The Tobira Acquisition added Cenicriviroc, a differentiated, complementary development program for the treatment of the multi-factorial elements of NASH, including inflammation, metabolic syndromes and fibrosis, to Allergan's global gastroenterology R&D pipeline.
Medical device manufacturers and their subcontractors are required to register their establishments and list their manufactured devices with the FDA and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with regulatory requirements. . with the Companys leading breast implants business. RISK FACTORS Risks Related to Our BusinessGlobal economic conditions could harm us. in this document.
The government/sponsor share originally was designed to provide a 25% discount in the cost of drugs by 2020, however the Bipartisan Budget Act of 2018 revised this percentage down to 5%.
Our sales and marketing efforts focus on both general practitioners and specialty physicians who specialize in the diagnosis and treatment of particular medical conditions. The information contained on the SECs website is not incorporated by reference into this Form 10-K and should not be considered to be part of this Form 10-K. While global economic conditions have been fairly stable as a whole in recent years, continued concerns about the systemic impact of potential geopolitical issues and economic policy uncertainty, particularly in areas in which we operate, could potentially cause economic and market instability in the future and could adversely affect the Companys business, including the Companys financial performance.
Allergan Plc - Strategy, SWOT and Corporate Finance Report, is a source of comprehensive company data and information. party partners, among others, will result in the successful discovery, development or launch of branded products that will prove to be commercially successful or will improve the long
Among other things, the FDA may withhold approval of NDAs, sNDAs, or other product applications of a facility if deficiencies are found at that facility.
There is always the chance that we will not obtain FDA or other necessary approvals, or that the rate, timing and cost of obtaining such approvals, will adversely affect our product introduction plans or impact operations. Any modification, revocation or nonrenewal of our environmental permits could have a material adverse effect on our ongoing operations, business and financial condition. Brazikumab is an anti-IL-23 monoclonal antibody that as of the acquisition date was in Phase IIb clinical development for the treatment of patients with moderate-to-severe Crohn's disease and was Phase II ready for ulcerative colitis and other conditions treated with anti-IL-23 monoclonal antibodies.
DBA ALLERGAN, PLC. ?c{OGO(h#_B $L|3=Ftak ' AI/ ?cp0nZ'oHou- g`VGPhX['=. Certain aspects of our operations are highly dependent upon thirdparty service providers. The Companies Act and other relevant aspects of Irish law differ in some material respects from laws generally applicable to U.S. corporations and shareholders, including the provisions relating to interested directors, mergers, amalgamations and acquisitions, takeovers, shareholder lawsuits and indemnification of directors.
in NOTE25 Commitments and Contingencies in the accompanying Notes to the Consolidated Financial Statements in this document. Global economic conditions could harm us.
24) are unlawful. As part of the sale, the Company received cash consideration of $550.0 million and is eligible to receive a contingent payment of up to an additional $100.0 million in the event that net sales of the divested products in a specified calendar year exceed a sales target, to which no fair value has been ascribed.
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