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1 | Page Danae Christodoulou, US Food and Drug Administration
Bios Danae Christodoulou, US Food and Drug Administration [email protected] Danae Christodoulou is an Acting Branch Chief in the Office of New Drug Products/OPQ/CDER. Danae joined FDA in 1998 and served as primary reviewer in the Office of New Drugs, as a Chemistry, Manufacturing and Controls Lead and Acting Branch Chief since 2013. Danae has a background in Inorganic Chemistry and received her Ph.D. from the University of Michigan, Ann Arbor, MI. Prior to FDA, Danae worked at Johnson Matthey Inc. R&D Drug Discovery as a Senior Research Chemist and at the National Cancer Institute, in Frederick, MD. Danae served as the Chair for the EI Implementation Working Group at FDA. Marjorie Coppinger, Teva [email protected] Marjorie Coppinger is Head of Global Generic Research Quality (SOD/SSL) for Teva Pharmaceuticals. She received B.A in Chemistry from the University of Notre Dame, Maryland and has over 21 years of experience at Teva Pharmaceuticals in analytical research and development, technical services, manufacturing, quality control, compendial compliance and quality assurance. Currently Ms. Coppinger is Co- Chair of the NJPQCA Compendial Discussion Group and has represented both NJPQCA and GPhA on various USP planning meetings, stakeholder initiatives and project groups for the USP. Elisabeth Corbett, Bristol-Myers Squibb. [email protected] Elisabeth Corbett is an Associate Director, CMC, in Global Regulatory Sciences at Bristol-Myers Squib in Pennington, NJ. She joined Bristol-Myers Squibb as a process engineer in Process Chemistry R&D in 2001. In 2008, she relocated to San Antonio, Texas and served in Quality roles before returning to CMC Regulatory at BMS in 2012. -
Teva to Acquire Cogenesys
TEVA PHARMACEUTICALS AND PERRIGO COMPANY ANNOUNCE THE U.S. LAUNCH OF GENERIC TEMOZOLOMIDE Jerusalem and Allegan, Mich. – August 12, 2013 – Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) and Perrigo Company (NYSE: PRGO;TASE) today announced the launch of the generic equivalent to Temodar® (temozolomide). Teva will manufacture, market and distribute the product in the U.S. and both companies will equally share in the cost and profitability of the product in the U.S. Teva was first to file, making the product eligible for 180 days of marketing exclusivity. This product is the generic equivalent to Temodar® (temozolomide), indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment and refractory anaplastic astrocytoma patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. Temodar® had annual sales of approximately $423 million in the United States, according to IMS data as of December 31, 2012. The launch of this product provides a quality alternative, making cancer therapy more cost effective for patients who suffer from this devastating cancer. Perrigo’s Chairman, President and CEO Joseph C. Papa stated, “This first-to-file launch with our partner Teva is another example of our focus to manufacture complex API’s. We are pleased to offer this important product to patients in the United States.” “We are pleased to partner with Perrigo to offer patients a high-quality, less expensive alternative of this important medicine. This launch demonstrates Teva’s commitment to continue to pursue first-to-market opportunities and enhance the value of our portfolio by concentrating on high-margin, low competition markets,” stated Allan Oberman, President and CEO of Teva Americas Generics. -
Teva Respiratory LLC V. Perrigo Pharmaceuticals
Case 1:20-cv-00207 ECF No. 1 filed 03/09/20 PageID.1 Page 1 of 21 IN THE UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF MICHIGAN ) ) TEVA RESPIRATORY, LLC, and TEVA ) PHARMACEUTICALS USA, INC., ) ) Civil Action No. 20-00207 ) Plaintiffs, ) ) v. ) ) PERRIGO PHARMACEUTICALS CO., and ) PERRIGO COMPANY PLC, ) ) Defendants. ) ) ) COMPLAINT Plaintiffs Teva Respiratory, LLC (“Teva Respiratory”) and Teva Pharmaceuticals USA, Inc. (“Teva USA”) (collectively, “Plaintiffs” or “Teva”), allege against defendants Perrigo Pharmaceuticals Co., and Perrigo Company plc (collectively, “Defendants” or “Perrigo”) as follows: INTRODUCTION 1. This case arises from Perrigo’s deliberate and unlawful attempt to misappropriate Teva’s federally registered trade dress for Teva’s revolutionary ProAir RespiClick® rescue respiratory inhaler and usurp and tarnish Teva’s goodwill. 2. Teva’s ProAir RespiClick® is the only albuterol rescue inhaler on the market that is “breath-activated”; it does not require any hand-breath coordination during inhalation. In other words, Teva’s ProAir RespiClick® enables users to get a rescue dose of albuterol during an asthma or COPD attack simply by breathing in. ProAir RespiClick® is a leading drug for the treatment of bronchospasm. -1- ACTIVE/102581507.4 Case 1:20-cv-00207 ECF No. 1 filed 03/09/20 PageID.2 Page 2 of 21 3. Teva’s ProAir RespiClick® design includes a white body and a distinctive red cap. Teva has a federally registered trademark on the ProAir RespiClick® design. 4. Teva also sells an earlier-generation albuterol rescue inhaler named ProAir® HFA, both as a branded product and as an authorized generic product. -
Bank Hapoalim B.M., Tel-Aviv, Israel
Bank Hapoalim B.M., Tel-Aviv, Israel 2016 Resolution Plan – Public Section Bank Hapoalim B.M. (“Bank Hapoalim”) is a publicly held banking corporation organized and operating under Israeli law, and subject to comprehensive supervision by the Bank of Israel. In the United States, Bank Hapoalim owns (through PCM-HSU Holdings, Inc., a Delaware-incorporated holding company) Hapoalim Securities USA, a Delaware-incorporated SEC-registered broker-dealer that has offices in New York, California, and Florida. Bank Hapoalim also operates Bank Hapoalim B.M. New York Branch (the “Insured Branch”), a New York state-licensed FDIC-insured branch; Bank Hapoalim B.M. Plaza Branch and Bank Hapoalim Americas Tower Branch, New York state-licensed uninsured branches; Bank Hapoalim B.M. Miami Branch, a Florida state-licensed uninsured branch; and Bank Hapoalim B.M. Los Angeles Representative Office, a California state-licensed representative office. Despite the relatively limited size of its US operations, Bank Hapoalim is subject to US resolution planning requirements under the Dodd-Frank Wall Street Reform and Consumer Protection Act because it has consolidated assets on a global basis of over $50 billion. Because of the relatively limited size and simplified structure of its US operations, Bank Hapoalim’s initial resolution plan, filed in December 2013, was an abbreviated or “tailored” resolution plan and Banks Hapoalim’s second resolution plan, filed in December 2014, was a brief update to its 2013 plan. Based on their review of the 2014 plan, by letter dated July 24, 2015, the FDIC and the Board of Governors of the Federal Reserve System (the “Agencies”) authorized Bank Hapoalim to file a resolution plan that focuses solely on (i) material changes to its 2014 resolution plan; (ii) any actions taken to strengthen the effectiveness of its plan; and (iii) its strategy for ensuring that the Insured Branch will be adequately protected from risks arising from the activities of Bank Hapoalim’s nonbank subsidiaries. -
Fact Sheet:Middle East and Africa ESG Screened Index Equity Sub
EMEA_INST Managed Pension Funds Limited Middle East and Africa ESG Screened Index Equity Sub-Fund Equities 30 June 2021 Fund Objective Performance ® The Sub-Fund aims to track the FTSE Developed Annualised Fund Benchmark Difference Middle East and Africa ex Controversies ex CW 1 Year (%) 23.30 23.28 0.01 Index, or its recognised replacement or equivalent. 3 Year (%) 4.75 4.84 -0.09 Investment Strategy 5 Year (%) 0.78 0.89 -0.11 The Sub-Fund primarily invests at all times in a Since Inception (%) 4.04 4.18 -0.14 sample of equities constituting the Index with such other securities as MPF shall deem it necessary Cumulative to capture the performance of the Index. Stock 3 Month (%) 11.54 11.51 0.04 index futures can be used for efficient portfolio 1 Year (%) 23.30 23.28 0.01 management. 3 Year (%) 14.95 15.24 -0.29 The following are excluded by the index provider from the index: Controversies (as defined by the ten 5 Year (%) 3.96 4.52 -0.56 principles of the UN Global Compact); Controversial Since Inception (%) 65.75 68.57 -2.81 weapons (including chemical & biological weapons, cluster munitions and anti-personnel landmines). Calendar 2021 (year to date) 9.74 9.71 0.03 Benchmark 2020 -1.28 -1.47 0.19 FTSE Developed Middle East and Africa ex 2019 10.82 11.07 -0.24 Controversies ex CW Index 2018 -0.47 -0.12 -0.35 Structure 2017 -10.77 -10.66 -0.12 Limited Company Past performance is not a guarantee of future results. -
The Advisory Committee for the FTSE Med-100 Index, Had Its Semi-Annual Meeting Today, 14Th of November 2012
The Advisory Committee for the FTSE Med-100 Index, had its semi-annual meeting today, 14th of November 2012. The FTSE Med-100 Index which was launched on the 19/6/2003 is composed of 100 stocks of three Exchanges (Athens Exchange, Tel-Aviv Stock Exchange and Cyprus Stock Exchange). The Advisory Committee of the index is comprised of representatives from the three Exchanges and also from the global index provider “FTSE Group”. During this meeting, the committee reviewed the operation of the index for the six months period between May 2012 – October 2012, in accordance with its ground rules, which follow international standards. Having applied the index rules, no changes are applicable in the constituent list of the index. The index is composed of 65 stocks listed on the Tel-Aviv Stock Exchange, 22 stocks listed on the Athens Exchange and 13 stocks listed on the Cyprus Stock Exchange. The list of the constituent 100 companies is as follows: Country Capital value (Euro million) 1 Teva Pharmaceutical Israel 27.292,7 2 Israel Chemicals Israel 12.219,9 3 Coca-Cola HBC Greece 6.031,4 4 Israel Corporation Israel 4.035,7 5 Bank Hapoalim Israel 3.986,6 6 Bank Leumi Israel 3.646,5 7 Bezeq Israel 2.556,6 8 Azrieli Group Israel 2.097,3 9 Mellanox Technologies Israel 1.947,6 10 Hellenic Petroleum (Cr) Greece 1.845,0 11 Natl Bank Of Greece Greece 1.710,1 12 Hellenic Telecom Greece 1.670,3 13 Delek Group Israel 1.668,5 14 Nice Systems Israel 1.603,7 15 Mizrahi Tefahot Bank Ltd. -
Public Companies Profiting from Illegal Israeli Settlements on Palestinian Land
Public Companies Profiting from Illegal Israeli Settlements on Palestinian Land Yellow highlighting denotes companies held by the United Methodist General Board of Pension and Health Benefits (GBPHB) as of 12/31/14 I. Public Companies Located in Illegal Settlements ACE AUTO DEPOT LTD. (TLV:ACDP) - owns hardware store in the illegal settlement of Ma'ale Adumim http://www.ace.co.il/default.asp?catid=%7BE79CAE46-40FB-4818-A7BF-FF1C01A96109%7D, http://www.machat.co.il/businesses.php, http://www.nytimes.com/2007/03/14/world/middleeast/14israel.html?_r=3&oref=slogin&oref=slogin&, http://investing.businessweek.com/research/stocks/snapshot/snapshot.asp?ticker=ACDP:IT ALON BLUE SQUARE ISRAEL LTD. (NYSE:BSI) - has facilities in the Barkan and Atarot Industrial Zones and operates supermarkets in many West Bank settlements www.whoprofits.org/company/blue- square-israel, http://www.haaretz.com/business/shefa-shuk-no-more-boycotted-chain-renamed-zol-b-shefa-1.378092, www.bsi.co.il/Common/FilesBinaryWrite.aspx?id=3140 AVGOL INDUSTRIES 1953 LTD. (TLV:AVGL) - has a major manufacturing plant in the Barkan Industrial Zone http://www.unitedmethodistdivestment.com/ReportCorporateResearchTripWestBank2010FinalVersion3.pdf (United Methodist eyewitness report), http://panjiva.com/Avgol-Ltd/1370180, http://www.haaretz.com/print-edition/business/avgol- sees-bright-future-for-nonwoven-textiles-in-china-1.282397 AVIS BUDGET GROUP INC. (NASDAQ:CAR) - leases cars in the illegal settlements of Beitar Illit and Modi’in Illit http://rent.avis.co.il/en/pages/car_rental_israel_stations, http://www.carrentalisrael.com/car-rental- israel.asp?refr= BANK HAPOALIM LTD. (TLV:POLI) - has branches in settlements; provides financing for housing projects in illegal settlements, mortgages for settlers, and financing for the Jerusalem light rail project, which connects illegal settlements with Jerusalem http://www.haaretz.com/print-edition/business/bank-hapoalim-to-lead-financing-for-jerusalem-light-rail-line-1.97706, http://www.whoprofits.org/company/bank-hapoalim BANK LEUMI LE-ISRAEL LTD. -
White Phosphorus (WP) and Smoke Mortars in 60Mm, 81Mm and 120Mm Calibers, Equipped with Point Detonating, Proximity and Electronic Time Fuses
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 for the fiscal year ended December 31, 2010 Commission File No. 0-28998 ELBIT SYSTEMS LTD. (Exact name of registrant as specified in its charter and translation of registrant’s name into English) Israel (Jurisdiction of incorporation or organization) Advanced Technology Center, Haifa 31053, Israel (Address of principal executive offices) Joseph Gaspar c/o Elbit Systems Ltd. P.O. Box 539 Advanced Technology Center Haifa 31053 Israel Tel: 972-4-831-6404 Fax: 972-4-831-6944 E-mail: [email protected] (Name, telephone, e-mail and/or facsimile number and address of Company contact person) Securities registered or to be registered pursuant to Section 12(b) of the Act: Ordinary Shares, nominal value 1.0 New Israeli Shekels per share (Title of Class) The NASDAQ Global Select Market (Name of each Exchange on which registered) Securities registered or to be registered pursuant to Section 12(g) of the Act: Not Applicable Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act: Not Applicable Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report: 42,693,340 Ordinary Shares Indicate by check mark whether the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes x No o If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. -
Wellbutrin Xl : Civil Action Antitrust Litigation : : : No
Case 2:08-cv-02433-GAM Document 419 Filed 05/11/12 Page 1 of 95 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA IN RE: WELLBUTRIN XL : CIVIL ACTION ANTITRUST LITIGATION : : : NO. 08-2431 (direct) : NO. 08-2433 (indirect) MEMORANDUM McLaughlin, J. May 11, 2012 TABLE OF CONTENTS Page I. Legal and Factual Background.. 2 A. The Drug Approval Process and Regulatory Framework. 2 B. The Citizen Petition Process. 4 C. Wellbutrin IR, Wellbutrin SR, and Wellbutrin XL.. 5 D. Noerr-Pennington Immunity and the Sham Exception. 7 E. Standard of Proof as to Objective Baselessness. 11 II. Overview.. 13 III. Biovail’s Conduct. 15 A. The Anchen Lawsuit. 15 B. The Watson Lawsuit. 26 C. The Abrika Lawsuit. 28 D. The Impax Lawsuit.. 43 E. The Citizen Petition. 50 IV. GSK’s Conduct. 82 A. The Impax and Watson Lawsuits.. 84 B. Biovail’s Citizen Petition. 86 Case 2:08-cv-02433-GAM Document 419 Filed 05/11/12 Page 2 of 95 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA IN RE: WELLBUTRIN XL : CIVIL ACTION ANTITRUST LITIGATION : : : NO. 08-2431 (direct) : NO. 08-2433 (indirect) MEMORANDUM McLaughlin, J. May 11, 2012 Wellbutrin XL is a once-a-day antidepressant containing the active pharmaceutical ingredient bupropion hydrochloride. It is produced by Biovail Corporation, Biovail Laboratories, Inc., and Biovail Laboratories International SRL1 (together, “Biovail”), and distributed by SmithKline Beecham Corporation and GlaxoSmithKline, PLC (together, “GSK”). The plaintiffs, direct and indirect purchasers of Wellbutrin XL, have sued Biovail and GSK for illegally conspiring to prevent generic versions of Wellbutrin XL from entering the American market by filing sham patent infringement lawsuits and a citizen petition with the Food and Drug Administration (“FDA”), and entering into agreements with generic companies to settle the lawsuits. -
2020 Annual Report Products
Products 2020 Annual Report From the CEO Dear Fellow Shareholders, Perrigo’s transformation to a pure-play Consumer Self-Care Company has come a long way LQMXVWWZRVKRUW\HDUV:HKDYHUHVWRUHGVXVWDLQDEOHWRSOLQHJURZWKGHOLYHUHGRQRXU¿QDQFLDO SURPLVHVUHFRQ¿JXUHGRXUSRUWIROLRRIEXVLQHVVHVXSGDWHGWKH,7LQIUDVWUXFWXUHDQGSURFHVVHV of the Company, expanded capacity, upgraded leadership talent, installed business intelligence capabilities, built a new product pipeline of over $500 million and re-instilled a sense of pride and energy among our 11,000 team members. Making this even more remarkable, is that we kept the WUDQVIRUPDWLRQRQWUDFNLQWKHIDFHRIWKHJOREDO&29,'SDQGHPLF,KRSH\RXDUHDVSURXGRI3HUULJR¶VJOREDOWHDP DV,DPIRUKRZWKH\ZRUNHGWRNHHSHDFKRWKHUVDIHNHSWRXUHVVHQWLDOSURGXFWVÀRZLQJDQGNHSWRXUWUDQVIRUPDWLRQ to a consumer self-care company on track through all of the personal and professional uncertainty that came their way LQ7KH\DUHKHURHV As a result of their efforts, Perrigo delivered strong net sales growth for the second year in a row in 2020 and World-wide Consumer sales reached a new record high. Equally important, the team stabilized adjusted operating income after a few years of decline even as we invested over $50 million in our business and overcame $35 million RIXQSODQQHGKHDGZLQGVGXHSULPDULO\WR&29,'UHODWHGVDIHW\FRVWVDQGEXVLQHVVLPSDFWIURPWKHZHDNFROG FRXJKDQGÀXVHDVRQUHODWHGWR&29,'¶VLPSDFWRQSXEOLFOLIH$OOLQDOOZHKDGDYHU\VWURQJ\HDU Our transformation efforts reached an essential milestone after the year closed when we announced the sale of RXU3UHVFULSWLRQ3KDUPDFHXWLFDOVEXVLQHVVWR$OWDULV&DSLWDO3DUWQHUV//&7KHWUDQVDFWLRQUHLQIRUFHVRXUDELOLW\ -
Israel and the Alien Tort Statute
Summer 2014 No.54 JTheUSTICE magazine of the International Association of Jewish Lawyers and Jurists In this issue The International Court of Justice Adjudicating the Arab-Israel Disputes? Boycotts, Divestment, Sanctions and the Law Israel and the Alien Tort Statute Corporations and Human Rights Zivotofsky v. Kerry - A Historical Constitutional Battle Preachers of Hate and Freedom of Expression UNRWA Panel at UN IAJLJ Activities The International Association of Jewish Lawyers and Jurists Honorary President: Hadassa Ben-Itto, Judge (Ret.) (Israel) Life time Member: Irwin Cotler, Prof. (Canada) Honorary Vice Presidents: Joseph Roubache (France) Oreste Bisazza Terracini, Dr. (Italy) Executive Committee: Board of Governors: President: Irit Kohn (Israel) Irit Kohn (Israel) Haim Klugman (Israel) Avraham (Avi) D. Doron (Israel) Deputy President: Meir Rosenne, Dr. (Israel) Haim Klugman (Israel) Mirella M. Bamberger (Israel) Alyza D. Lewin (USA) Vice President and Treasurer: Marcos Arnoldo Grabivker, Judge (Argentina) Avraham (Avi) D. Doron (Israel) Maurizio Ruben (Italy) Alex Hertman (Israel) Vice President and Coordinator with Amos Shapira, Prof. (Israel) International Organizations: Avishai Sapir (Israel) Meir Rosenne, Dr. (Israel) David Pardes (Belgium) Dov Shefi, Brig. (Ret.) (Israel) Vice President and Secretary General: Edna Bekenstein, Judge (Ret.) (Israel) Mirella M. Bamberger (Israel) Edna Kaplan-Hagler, Judge (Ret.) Dr. (Israel) Efraim (Efi) Chalamish, Dr. (USA) Vice Presidents: Ethia Simha (Israel) Alyza D. Lewin (USA) Jeremy D. Margolis (USA) Marcos Arnoldo Grabivker, Judge (Argentina) Jimena Bronfman (Chile) Maurizio Ruben (Italy) Jonathan Lux (UK) Lipa Meir, Dr. (Israel) Academic Adviser: Mala Tabory, Dr. (Israel) Yaffa Zilbershats, Prof. (Israel) Maria Canals De-Cediel, Dr. (Switzerland) Meir Linzen (Israel) Representatives to the U.N. -
BIG SHOPPING CENTERS BIG Shopping Centers Ltd
BIG 1 BIG SHOPPING CENTERS BIG Shopping Centers Ltd. ("BIG") - headquartered in Herzelia, Israel - was founded in 1994 by Yehuda Naftali with the vision of developing American styled open-air shopping centers in Israel. Today, the company operates in three countries - Israel, the United States and Serbia - where it has ownership (entire or partnership) in 58 projects, 51 of them being operational shopping centers and 7 under development. BIG is a publicly traded company, traded on the Tel Aviv Stock Exchange, and listed in the TA 100 Index (top 100 companies in the stock exchange). The company was traded on the TASE on May 2016 at over $700 million, and it's total balance sheet assets on December 31, 2015 was at $1.995 billion. *Values in this book were derived from an exchange rate of 3.75 NIS/1 $US BIG 2 BIG 3 TABLE OF CONTENTS 04 BIG'sTeam 10 Company Overview 22 Our Partners 26 Property Portfolio 64 Financial Data 70 Our Goals BIG 5 Yehuda Naftali | Chairman of the Board & Founder Mr. Naftali has an active role in navigating the company, and setting its goals and strategies. Mr. Naftali has over 40 years' of experience in the business of site location, construction and management of open air shopping centers. His real estate career began in West Hollywood and West Los Angeles developing and redeveloping commercial properties for retailers. Eitan Bar Zeev | Director & C.E.O Mr. Bar Zeev serves as the principal leadership role for the execution of BIG's overall business strategy, and brings a variety of experience in all aspects of retail, marketing, acquisitions and brand building.