TEVA PHARMACEUTICAL INDUSTRIES LIMITED (Exact Name of Registrant As Specified in Its Charter)

Total Page:16

File Type:pdf, Size:1020Kb

TEVA PHARMACEUTICAL INDUSTRIES LIMITED (Exact Name of Registrant As Specified in Its Charter) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 8, 2019 TEVA PHARMACEUTICAL INDUSTRIES LIMITED (Exact Name of registrant as specified in its charter) Israel 001-16174 Not Applicable (State or other jurisdiction (Commission (IRS Employer of incorporation) File Number) Identification No.) 5 Basel Street P.O. Box 3190 Petach Tikva 4951033, Israel (Address of Principal Executive Offices, including Zip Code) +972-3-914-8171 (Registrant’s Telephone Number, including Area Code) Not Applicable (Former Name or Former Address, if Changed Since Last Report) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ Item 1.01. Entry into a Material Definitive Agreement Revolving Credit Agreement On April 8, 2019, Teva Pharmaceutical Industries Ltd. (“ Teva ”) and certain of its subsidiaries entered into a $2.3 billion senior unsecured revolving credit agreement (the “ Revolving Credit Agreement ”) with a syndicate of banks, arranged by Bank of America Merrill Lynch International Designated Activity Company and HSBC Bank plc, as Coordinating Bookrunners and Mandated Lead Arrangers, Barclays Bank PLC, BNP Paribas Dublin Branch, Citibank, N.A., London Branch, Credit Suisse Loan Funding LLC, Goldman Sachs Bank USA, JPMorgan Chase Bank, N.A., Mizuho Bank, Ltd., Morgan Stanley Senior Funding, Inc., MUFG Bank, Ltd., Sumitomo Mitsui Banking Corporation and PNC Bank National Association, as Bookrunners & Mandated Lead Arrangers, Banca IMI, as Lead Arranger, and Bank of America, N.A., as Administrative Agent. The Revolving Credit Agreement provides for two separate tranches of commitments, a $1.15 billion Tranche A and a $1.15 billion Tranche B, and loans and letters of credit will be available from time to time under each tranche for Teva’s general corporate purposes. Tranche A has a maturity date of April 8, 2022, with two one year extension options, and will bear interest at LIBOR plus a margin ranging from 0.900% to 1.900% based on Teva’s credit rating from time to time. Tranche B has a maturity date of April 8, 2024, and will bear interest at LIBOR plus a margin ranging from 1.100% to 2.100% based on Teva’s credit rating from time to time. The commitments under each Tranche will also be subject to a commitment fee on undrawn amounts ranging from (i) in the case of Tranche A commitments, 0.225% to 0.570% and (ii) in the case of Tranche B commitments, 0.275% to 0.630%, in each case, based on Teva’s credit rating from time to time. Funding of the loans under the Revolving Credit Agreement is subject to customary drawdown conditions. The Revolving Credit Agreement contains certain customary affirmative and negative covenants for facilities of this type, including certain reporting obligations and certain limitations on dispositions; mergers or consolidations; restricted payments; and limitations on liens, encumbrances and certain indebtedness. The Revolving Credit Agreement contains two financial maintenance covenants, (i) a maximum leverage ratio stepping down from 6.25x to 3.50x over the life of the facility and (ii) a static minimum interest coverage ratio of 3.50x. The Revolving Credit Agreement also contains customary events of default, including non-compliance with one or more of the covenants. In connection with entry into the Revolving Credit Agreement, Teva’s existing $3.0 billion senior unsecured revolving credit agreement will be terminated. The foregoing description of the Revolving Credit Agreement does not purport to be complete and is qualified in its entirety by reference to the Revolving Credit Agreement, which is filed as Exhibit 10.1 hereto and is incorporated herein by reference. Item 2.03. Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant. The information set forth in Item 1.01 of this Current Report on Form 8-K is incorporated by reference herein. ITEM 9.01 Financial Statements and Exhibits (d) Exhibits EXHIBITS 10.1 Senior Unsecured Revolving Credit Agreement, dated as of April 8, 2019, by and among Teva Pharmaceutical Industries Limited, Teva Pharmaceuticals USA, Inc., Teva Pharmaceutical Finance Netherlands III B.V., Teva Pharmaceutical Finance Netherlands II B.V., Bank of America, N.A. and the lenders party thereto. SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. TEVA PHARMACEUTICAL INDUSTRIES LTD. By: /s/ Michael McClellan Name: Michael McClellan Title: Executive Vice President and Chief Financial Officer Date: April 10, 2019 Exhibit 10.1 EXECUTION VERSION US$2,300,000,000 SENIOR UNSECURED REVOLVING CREDIT AGREEMENT dated as of April 8, 2019 among TEVA PHARMACEUTICAL INDUSTRIES LIMITED, TEVA PHARMACEUTICALS USA, INC., TEVA PHARMACEUTICAL FINANCE NETHERLANDS II B.V. and TEVA PHARMACEUTICAL FINANCE NETHERLANDS III B.V., as Borrowers, THE LENDERS PARTY HERETO FROM TIME TO TIME, and BANK OF AMERICA, N.A., as Administrative Agent BANK OF AMERICA MERRILL LYNCH INTERNATIONAL DESIGNATED ACTIVITY COMPANY AND HSBC BANK PLC, as Coordinating Bookrunners & Mandated Lead Arrangers, BARCLAYS BANK PLC, BNP PARIBAS DUBLIN BRANCH, CITIBANK, N.A., LONDON BRANCH, CREDIT SUISSE LOAN FUNDING LLC, GOLDMAN SACHS BANK USA, JPMORGAN CHASE BANK, N.A., MIZUHO BANK, LTD., MORGAN STANLEY SENIOR FUNDING, INC., MUFG BANK, LTD., SUMITOMO MITSUI BANKING CORPORATION AND PNC BANK NATIONAL ASSOCIATION, as Bookrunner & Mandated Lead Arrangers, and BANCA IMI, as Lead Arranger Baker & McKenzie LLP 100 New Bridge Street London EC4V 6JA United Kingdom www.bakermckenzie.com Table of contents ARTICLE 1 DEFINITIONS AND ACCOUNTING TERMS 1 Section 1.01 Defined Terms 1 Section 1.02 Terms Generally 27 Section 1.03 Accounting Terms; GAAP 28 Section 1.04 Resolution of Drafting Ambiguities 29 ARTICLE 2 THE CREDITS 29 Section 2.01 Commitments 29 Section 2.02 Loans 29 Section 2.03 Requests for Loans 30 Section 2.04 Funding of Loans 31 Section 2.05 Interest Elections 32 Section 2.06 Termination and Reduction of Commitments 33 Section 2.07 Repayment of Loans; Evidence of Debt 34 Section 2.08 Prepayment of Loans 36 Section 2.09 Fees 37 Section 2.10 Interest 38 Section 2.11 Alternate Rate of Interest 40 Section 2.12 Increased Costs 41 Section 2.13 Illegality 42 Section 2.14 Break Funding Payments 43 Section 2.15 Taxes 44 Section 2.16 Payments Generally; Pro Rata Treatment; Sharing of Set-offs 48 Section 2.17 Mitigation Obligations; Replacement of Lenders 50 Section 2.18 Swingline Loans 52 Section 2.19 Letters of Credit 54 Section 2.20 Defaulting Lenders 60 Section 2.21 Joint and Several Liability of Borrowers 63 Section 2.22 Successor LIBOR 65 ARTICLE 3 REPRESENTATIONS AND WARRANTIES 66 Section 3.01 Organization; Powers 66 Section 3.02 Authorization; Enforceability 67 i Section 3.03 Approvals; No Conflicts 67 Section 3.04 Financial Condition; No Material Adverse Change 67 Section 3.05 Litigation 68 Section 3.06 Environmental Matters 68 Section 3.07 Disclosure 68 Section 3.08 Solvency 68 Section 3.09 ERISA 68 Section 3.10 Investment Company Status 68 Section 3.11 Margin Securities 69 Section 3.12 Properties 69 Section 3.13 Compliance with Laws and Agreements 69 Section 3.14 Sanctions; Anti-Corruption Laws 69 Section 3.15 FATF 70 Section 3.16 Taxes 70 Section 3.17 Pari Passu Ranking 70 Section 3.18 Permits, Etc. 70 Section 3.19 Insurance 70 Section 3.20 No Filing or Stamp Tax 70 Section 3.21 No Loan Parties are EEA Financial Institutions 71 ARTICLE 4 CONDITIONS 71 Section 4.01 Effective Date 71 Section 4.02 Each Credit Event 72 ARTICLE 5 AFFIRMATIVE COVENANTS 73 Section 5.01 Financial Statements and Other Information 73 Section 5.02 Notices of Material Events 74 Section 5.03 Existence; Conduct of Business 75 Section 5.04 Payment of Taxes 75 Section 5.05 Maintenance of Properties; Insurance 75 Section 5.06 Books and Records; Inspection Rights 75 Section 5.07 Compliance with Laws 76 Section 5.08 Use of Proceeds 76 Section 5.09 Environmental Laws, Etc. 76 ii Section 5.10 Ratings 76 Section 5.11 Sanctions; Anti-Corruption Laws 76 ARTICLE 6 NEGATIVE COVENANTS 76 Section 6.01 Fundamental Changes and Asset Sales 77 Section 6.02 Fiscal Year and Accounting 78 Section 6.03 Negative Pledge 78 Section 6.04 Financial Covenants 80 Section 6.05 Capital Markets Indebtedness 81 Section 6.06 Sanctions; Anti-Corruption Laws; Use of Proceeds 82 Section 6.07 FATF 82 ARTICLE 7 EVENTS OF DEFAULT 82 Section 7.01 Events of Default 82 ARTICLE 8 THE ADMINISTRATIVE AGENT 85 Section 8.01 Appointment and Authority 85 Section 8.02 Administrative Agent Individually 85 Section 8.03 Duties of Administrative Agent; Exculpatory Provisions 86 Section 8.04 Reliance by Administrative Agent, Etc.
Recommended publications
  • 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.
    [Show full text]
  • 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.
    [Show full text]
  • 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.
    [Show full text]
  • 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.
    [Show full text]
  • 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\
    [Show full text]
  • Quarterly Federal Court Litigation Status Report
    QUARTERLY FEDERAL COURT LITIGATION STATUS REPORT Office of the General Counsel Bureau of Competition Bureau of Consumer Protection Regional Offices March 31, 2017 No. 131 TABLE OF CONTENTS SUMMARY OF CASES................................................................................................................. ii PETITIONS FOR REVIEW ........................................................................................................... 1 A) Orders to Cease and Desist ............................................................................................ 1 B) Rulemakings ................................................................................................................... 2 INJUNCTION AND CONSUMER REDRESS CASES ................................................................ 3 A) Preliminary Injunctions (Mergers/Acquisitions) ............................................................ 3 B) Preliminary Injunctions (Other) ..................................................................................... 4 C) Permanent Injunctions/Consumer Redress ..................................................................... 4 CIVIL PENALTY AND ENFORCEMENT CASES ................................................................... 82 A) Consumer Protection .................................................................................................... 82 B) Competition .................................................................................................................. 89 SUBPOENA AND CID ENFORCEMENT
    [Show full text]
  • GLAXOSMITHKLINE LLC V. TEVA PHARMACEUTICALS USA, INC
    Case: 18-1976 Document: 111 Page: 1 Filed: 10/02/2020 United States Court of Appeals for the Federal Circuit ______________________ GLAXOSMITHKLINE LLC, SMITHKLINE BEECHAM (CORK) LIMITED, Plaintiffs-Appellants v. TEVA PHARMACEUTICALS USA, INC., Defendant-Cross-Appellant ______________________ 2018-1976, 2018-2023 ______________________ Appeals from the United States District Court for the District of Delaware in No. 1:14-cv-00878-LPS-CJB, Chief Judge Leonard P. Stark. ______________________ Decided: October 2, 2020 ______________________ JUANITA ROSE BROOKS, Fish & Richardson, PC, San Diego, CA, argued for plaintiffs-appellants. Also represented by MICHAEL ARI AMON, CRAIG E. COUNTRYMAN, JONATHAN ELLIOT SINGER; ELIZABETH M. FLANAGAN, MICHAEL J. KANE, WILLIAM WOODFORD, Minneapolis, MN; DOUGLAS E. MCCANN, Wilmington, DE. WILLIAM M. JAY, Goodwin Procter LLP, Washington, DC, argued for defendant-cross-appellant. Also represented by JAIME ANN SANTOS; ELAINE BLAIS, J. Case: 18-1976 Document: 111 Page: 2 Filed: 10/02/2020 2 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. ANTHONY DOWNS, ROBERT FREDERICKSON, III, CHRISTOPHER T. HOLDING, ALEXANDRA LU, LANA S. SHIFERMAN, DARYL L. WIESEN, Boston, MA; IRA J. LEVY, New York, NY. HANSJORG SAUER, Biotechnology Innovation Organization, Washington, DC, for amicus curiae Biotechnology Innovation Organization. Also represented by MELISSA A. BRAND; BRIAN PAUL BARRETT, Eli Lilly and Company, Indianapolis, IN. MICHAEL N. KENNEDY, Covington & Burling LLP, Washington, DC, for amicus curiae Pharmaceutical Research and Manufacturers of America. Also represented by STEVEN JOHN WINKELMAN; DAVID EVAN KORN, Pharmaceutical Research and Manufacturers Association of America, Washington, DC. ANDREW CURTIS NICHOLS, Winston & Strawn LLP, Washington, DC, for amicus curiae Association for Accessible Medicines. Also represented by GEORGE C.
    [Show full text]
  • 20200313170134437 to FILE --Actavis Contrave Cert Petition.Pdf
    No. IN THE Supreme Court of the United States ACTAVIS LABORATORIES FL, INC., Petitioner, v. NALPROPION PHARMACEUTICALS LLC Respondent. On Petition for a Writ of Certiorari to the United States Court of Appeals for the Federal Circuit PETITION FOR A WRIT OF CERTIORARI GERARD J. CEDRONE WILLIAM M. JAY THOMAS MCTIGUE IV Counsel of Record GOODWIN PROCTER LLP JAIME A. SANTOS 100 Northern Avenue GOODWIN PROCTER LLP Boston, MA 02210 1900 N Street, N.W. Washington, DC 20036 SCOTT J. BORNSTEIN [email protected] JONATHAN D. BALL (202) 346-4000 RICHARD C. PETTUS JUSTIN A. MACLEAN ALEXANDRA D. VALENTI GREENBERG TRAURIG LLP GOODWIN PROCTER LLP 200 Park Avenue 620 Eighth Avenue New York, NY 10166 New York, NY 10018 March 13, 2020 Counsel for Petitioner QUESTION PRESENTED Under 35 U.S.C. § 112, a patent’s specification must “contain a written description of the invention.” That requirement, a cornerstone of federal patent law, ensures that an inventor can claim patent pro- tection only for what she actually invented. Consistent with this Court’s longstanding di- rective that every element of a patent claim must be treated as material, the Federal Circuit has long held that all elements of a patent’s claims must ac- tually be disclosed in the patent’s specification. But the Federal Circuit has now broken from that estab- lished rule. In the 2-1 decision below, the Federal Circuit announced for the first time that for some claim limitations, a “substantially equivalent” disclo- sure will do. Here, although the claims expressly re- quire testing using one specific method identified by name, the court held that the written description’s disclosure of a different testing method was good enough.
    [Show full text]
  • Trazodone Hydrochloride Tablets, Usp
    TRAZODONE HYDROCHLORIDE- trazodone hydrochloride tablet Lake Erie Medical DBA Quality Care Products LLC ---------- TRAZODONE HYDROCHLORIDE TABLETS, USP Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of trazodone HCl or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Trazodone HCl is not approved for use in pediatric patients. (See WARNINGS, Clinical Worsening and Suicide Risk, PRECAUTIONS, Information for Patients, and PRECAUTIONS, Pediatric Use DESCRIPTION Trazodone Hydrochloride Tablets USP is an antidepressant chemically unrelated to tricyclic, tetracyclic, or other known antidepressant agents. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1, 2, 4-triazolo[4, 3-a]-pyridin- 3(2H)-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water.
    [Show full text]
  • Printmgr File
    SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 under the Securities Exchange Act of 1934 For the month of November 2011 Commission File Number 0-16174 TEVA PHARMACEUTICAL INDUSTRIES LIMITED (Translation of registrant’s name into English) 5 Basel Street, P.O. Box 3190 Petach Tikva 49131 Israel (Address of principal executive offices) Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F: Form 20-F ⌧ Form 40-F Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): TEVA PHARMACEUTICAL INDUSTRIES LIMITED INDEX Page Consolidated Statements of Income 2 Consolidated Balance Sheets 3 Consolidated Statements of Cash Flow 4 Notes to Condensed Consolidated Financial Statements 5 Operating and Financial Review and Prospects 23 Risk Factors 43 Quantitative and Qualitative Disclosures About Market Risk 44 Legal Proceedings 44 Exhibits As listed below, attached as Exhibit 101 to this Report on Form 6-K is certain information contained in this Report on Form 6-K of Teva Pharmaceutical Industries Limited relating to the three and nine months ended September 30, 2011, formatted in XBRL (Extensible Business Reporting Language). Users of this data are advised, in accordance with Rule 406T of Regulation S-T promulgated by the Securities and Exchange Commission, that this Interactive Data File is deemed not filed or part of a registration statement or prospectus for purposes of sections 11 or 12 of the Securities Act of 1933, is deemed not filed for purposes of section 18 of the Securities Exchange Act of 1934, and otherwise is not subject to liability under these sections.
    [Show full text]
  • Generic Pharmaceuticals Mdl 2724 Pricing Antitrust Litigation 16-Md-2724 ______Hon
    IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA __________________________________________ IN RE: GENERIC PHARMACEUTICALS MDL 2724 PRICING ANTITRUST LITIGATION 16-MD-2724 __________________________________________ HON. CYNTHIA M. RUFE THIS DOCUMENT RELATES TO: Civil Action Nos. The State Attorneys General Litigation 17-3768 The Kroger Co. v. Actavis Holdco U.S., Inc. 18-284 1199SEIU Nat’l Benefit Fund v. Actavis Holdco US, Inc. 18-2401 West Val Pharmacy v. Actavis Holdco U.S., Inc. 18-2533 Ahold USA, Inc. v. Actavis Holdco U.S., Inc. 18-2641 Humana Inc. v. Actavis Elizabeth, LLC 18-3299 Marion Diagnostic Center, LLC v. McKesson Corp. 18-4137 _________________________________________ OPINION Rufe, J. August 15, 2019 This is a multidistrict antitrust litigation involving allegations that certain pharmaceutical companies engaged in an unlawful scheme or schemes to fix, maintain, and stabilize prices, rig bids, and engage in market and customer allocations of certain generic pharmaceutical products. In this Opinion, the Court considers Defendants’ joint motion to dismiss claims asserting the existence of an overarching multi-drug conspiracy in the following pleadings (collectively, the “Overarching Complaints”): Direct Purchaser Plaintiffs’ First Amended Class Action Complaint ¶¶ 108-1211; End Payor Plaintiffs’ Amended Class Action Complaint ¶¶ 99-1812; Indirect Reseller Plaintiffs’ Amended Overarching Complaint ¶¶ 65-723; Kroger Plaintiffs’ Amended Complaint ¶¶ 813-324; Marion Plaintiffs’ Second Amended Complaint, ¶¶ 51-595; Humana Inc.’s Second Amended Complaint ¶¶ 261-726; and the Plaintiff States’ Consolidated Amended 1 The Direct Purchaser Plaintiffs (“DPPs”) allege they directly purchased generic pharmaceuticals from Defendants. They include the following drug purchasing cooperatives and retail pharmacy operators: Ahold, USA, Inc.; César Castillo, Inc.; FWK Holdings, LLC; KPH Healthcare Services, Inc.
    [Show full text]
  • Other As Well (Not Just with Teva)
    No. 19-1010 ================================================================================================================ In The Supreme Court of the United States --------------------------------- ♦ --------------------------------- ACTAVIS HOLDCO US, INC., et al., Petitioners, v. STATE OF CONNECTICUT, et al., Respondents. --------------------------------- ♦ --------------------------------- On Petition For Writ Of Certiorari To The United States Court Of Appeals For The Third Circuit --------------------------------- ♦ --------------------------------- RESPONDENTS’ APPENDIX TO BRIEF IN OPPOSITION TO PETITION FOR WRIT OF CERTIORARI --------------------------------- ♦ --------------------------------- WILLIAM TONG Attorney General of Connecticut *CLARE KINDALL Solicitor General W. J OSEPH NIELSEN ROBERT J. DEICHERT Assistant Attorneys General OFFICE OF THE ATTORNEY GENERAL 165 Capitol Avenue Hartford, CT 06106 (860) 808-5261 [email protected] Counsel for State of Connecticut and Liaison Counsel for Respondent States *Counsel of Record (Additional Counsel On Inside Cover And On Signature Pages) ================================================================================================================ ROBERTA D. LIEBENBERG JEFFREY S. ISTVAN FINE, KAPLAN AND BLACK, R.P.C. One South Broad Street, 23rd Floor Philadelphia, PA 19107 (215) 567-6565 rliebenberg@finekaplan.com Lead Counsel for the End-Payer Plaintiffs DIANNE M. NAST NASTLAW LLC 1101 Market Street, Suite 2801 Philadelphia, PA 19107 (215) 923-9300 [email protected] Lead
    [Show full text]