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As filed with the Securities and Exchange Commission on December 17, Washington, D. For the fiscal year ended. Date of event requiring peraonal shell company report.
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These estimates may be revised and may include additional assets acquired or liabilities assumed as additional information becomes available and as additional analyses are performed.
We carry ificant amounts of goodwill and intangible assets on our balance sheet as a result of past acquisitions. The EU also provides a system of regulatory data exclusivity for authorized human medicines, which runs in parallel to any patent protection. Table of Contents We will be subject to additional risks arising from the acquired businesses of Shire and from the legal, regulatory and tax regimes that Shire operates under. We are also pursuing further improvements in specialty capabilities, particularly for unmet treatment needs, while making targeted acquisitions and divestitures to further increase our level of focus on our key growth drivers.
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Any such adverse changes could materially and adversely affect our business, of operations or financial metropoliatn.
Therefore, if we are unable to successfully defend against infringement claims by third parties, our financial could be materially and adversely affected. Regulatory authorities in many countries have worked to enhance post-approval monitoring in recent years, which has increased post-approval regulatory burdens. Our global operations, which encompass more than 70 countries in diverse regions across the world, are subject to a of risks, including the following:.
Out-d to Otsuka Pharmaceutical Co. Partnership with AstraZeneca. In particular, patent protection in emerging markets is often less certain than in developed markets.
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Batman embarks on a personal vendetta to end his reign on Earth. Our corporate website is www. However, price reduction remains a major priority, and there is a strong possibility that government officials will continue to search for additional ways to reduce or control prices, including new federal or state legislation mandating drug price controls, which could include limits on annual price increases or maximum price levels.
Competitors in the prescription drug industry include large international companies whose capabilities cover the entire drug creation process from research and development to production and marketing. If we are unable to successfully remediate any material weaknesses or other deficiencies in our internal control over financial mftropolitan, the accuracy and timing of our financial reporting may be adversely affected and investors may lose confidence in.
This program includes both remaining vigilant against patent infringement by others as well as exercising caution, starting at the research and development stage, metropolitaj ensure that our products and activities do not violate intellectual property rights held by others.
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The deposit agreement governing the s provides that, to the fullest extent permitted by law, holders waive the right to a jury trial for any claim they may have against us or the depositary arising out of or relating to our shares, the s or the deposit agreement, which may include any claim under the U. The U.
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The drug owner must submit periodic reports to the FDA, including any cases of adverse reactions. Item 16C.
If we are unable to maintain the competitiveness of our products, our business, financial position and of operations could be metorpolitan and adversely affected. Indicate by check mark which basis of ing the registrant has metropolihan to prepare the financial statements included in this filing:. If we are not able to achieve the anticipated benefits of any future acquisitions in full or in a timely manner, we could be required to recognize impairment losses, we may not be able to recoup our investment, and our business, financial position and of operations could be materially and adversely affected.
Zds Pipeline. We believe that there is a compelling strategic and financial rational for undertaking the Shire Acquisition, and that the Shire Acquisition will allow us to create a global, values-based, research and development-driven biopharmaceutical company incorporated and headquartered in Japan, with an attractive geographic footprint and the scale to drive future development. If our data systems are personnal, our business operations may be impaired, we may lose profitable opportunities or the value of those opportunities may be diminished, and we may lose revenue because of und use of our intellectual property.
We focus our research and development efforts on our three key therapeutic areas: GI, oncology and neuroscience, plus vaccines. Our Intellectual Property Department supports our overall corporate strategy by focusing efforts on three main themes:. Craig Jung takes a personal interest in the North County Health Ramona resident Craig Jung applies his experience in health care While working at Hillside, Jung met his future wife LaDawn, who staffed the business office at the time.
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Teva Pharmaceutical Industries Ltd. We may face ificant challenges in combining the infrastructure, management and information systems of acquired companies with ours, including integrating research and development, manufacturing, distribution, marketing and promotion activities and information technology systems.
SPCs are deed to compensate the owner of the patent for the time it took to receive marketing authorization by the European Health Authorities. Table of Contents contingent or other liabilities, or be required to mark up the fair value of liabilities or mark down the fair value of assets acquired upon the close of an acquisition. However, we believe that a contractual pre-dispute jury trial waiver provision is generally enforceable, including under the laws of the State of New York, which govern the deposit agreement, or by a federal or state court in the City of New York, which has jurisdiction over matters arising under the deposit agreement.
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The Sec Sun · Orlando Sentinel · The Morning Call of Pa. In the U. Major Shareholders and Related Party Transactions. If we are unable to effectively manage these additional risks, our business, of operations or financial conditions following the completion of the Shire Acquisition could be materially and adversely affected.
Check one :. Specifically, we may encounter the following difficulties:. Japan and other regions in the world in which we operate are subject to the risk of earthquakes and other natural disasters, including volcanic eruptions, tidal waves, typhoons, floods and hurricanes. Share capital.
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In addition, in connection with its acquisition of Baxalta Inc. Table of Contents our financial reporting, maroet the price of our s may decline as a result. This estimate does not include integration costs, interest on indebtedness and other financial expenses, as the amount of those expenses is dependent on the timing of the completion of the Shire Acquisition.
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