DOCSLIB.ORG

Neuroscience Education Institute Full-Disclosure Form Title/Affiliation

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text

Load more

1930 Palomar Point Way, Ste. 101 Neuroscience Education Institute Carlsbad, CA 92008 Tel 760-931-8857 Fax 760-931-8713 Full-Disclosure Form NEI requires all planners, teachers/speakers, and authors/content developers involved with CME content to disclose all financial relationships with potential commercial supporters of NEI activities; i.e., manufacturers and/or developers of psychopharmacological substances. Financial relationships reported in this form will be reviewed for any potential conflicts of interest with respect to each activity. Any potential conflicts will be identified and resolved during the planning phase of each activity. Name: ______________________________________________________________________________________ Credentials: _____________________ Title/Affiliation:__________________________________________________________________________________________________ ______________________________________________________________________________________________________________ Please indicate your role in previous/current NEI CME activities (check all that apply): Faculty Author Content Editor Peer Reviewer Course Chair / Planning Committee Editorial / Design Staff Employee Other: _______________________________________ DISCLOSURE Have you (or your spouse/partner) had a financial relationship in the last 12 months with potential commercial supporters Yes No of NEI activities; i.e., manufacturers and/or developers of psychopharmacological substances? If NO, skip to DECLARATION section (last page). If YES, please list your relationships and approaches to resolutions in the COMMERCIAL INTERESTS section below. FINANCIAL RELATIONSHIPS WITH COMMERCIAL INTERESTS -- within the last 12 months Nature of Financial Relationship Divested? Company Name Research Consultant Speakers Board (producers of health care goods or services) Stock Other / Grant / Advisor Bureau Member Abbey Pharmaceuticals Abbott Laboratories Abiant ACADIA Pharmaceuticals Inc. Acologix, Inc. Actelion Ltd Addex Pharmaceuticals SA Addrenex Pharmaceuticals, Inc. Alkermes, Inc. ALZA Corporation Amgen Inc. Amylin Pharmaceuticals, Inc Arena Pharmaceuticals, Inc. Full_Disclosure_Form.doc Page 1 of 6 NEI Full-Disclosure Form, continued continued Company Name Research Consultant Speakers Board Stock Other Divested? (producers of health care goods or services) / Grant / Advisor Bureau Member Asahi Kasei Pharma AstraZeneca Pharmaceuticals LP Avanir Pharmaceuticals Aventis Pharmaceuticals Inc. Avera Pharmaceuticals, Inc. Azur Pharma Inc Barr Laboratories, Inc. Barr Pharmaceuticals, Inc. Becton, Dickenson and Company Biovail Pharmaceuticals, Inc. BMC-JR LLC Boehringer Ingelheim Pharmaceuticals, Inc. BrainCells Inc. Bristol-Myers Squibb Company CeNeRx BioPharma, Inc. Cephalon, Inc. Corcept Therapeutics Inc. Cortex Pharmaceuticals, Inc CSC Pharmaceuticals Cyberonics Cypress Bioscience, Inc. Dainippon Sumitomo Pharma Co., Ltd. Dews Research LLC DOV Pharmaceutical, Inc. Duramed Pharmaceuticals Inc. Eisai Inc. Elan Pharmaceuticals, Inc. Eli Lilly and Company EPIX Pharmaceuticals, Inc. Evotec OAI AG Fabre-Kramer Pharmaceuticals, Inc. Ferring Pharmaceuticals A/S Forest Laboratories, Inc. Forest Pharmaceuticals, Inc. Forest Research Institute Genentech, Inc. GlaxoSmithKline H. Lundbeck A/S Hypnion Inc Hythiam, Inc. Full_Disclosure_Form.doc Page 2 of 6 NEI Full-Disclosure Form, continued continued Company Name Research Consultant Speakers Board Stock Other Divested? (producers of health care goods or services) / Grant / Advisor Bureau Member Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. Janssen, L.P. Janssen-Ortho Inc. Jazz Pharmaceuticals, Inc. JDS Pharmaceuticals, LLC Johnson & Johnson Johnson & Johnson Pharmaceutical Services, L.L.C. Johnson & Johnson Pharmaceutical Research & Development, L.L.C. King Pharmaceuticals, Inc. KV Pharmaceutical Company Labopharm Inc. LifeScan, Inc. Lundbeck Pharmaceuticals Ltd. Lupin Pharmaceuticals, Inc. Mallinckrodt Pharmaceuticals McNeil Consumer & Specialty Pharmaceuticals McNeil Pharmaceutical MediciNova, Inc. Meiji Pharmaceuticals Co., Ltd. Memory Pharmaceuticals Corp. Merck & Co., Inc. Merck Sharp & Dohme Limited Merck/Schering Plough Neurim Pharmaceuticals (1991) Ltd. Neurochem Inc. Neurocrine Biosciences Inc. Neurogen Corporation NeuroMolecular Pharmaceuticals Neuronetics, Inc. New River Pharmaceuticals Inc. NovaDel Pharma Inc. Novartis Novo Nordisk A/S Omega Pharma NV Orexo AB Organon Orgenics, Ltd. Orphan Medical, Inc. Ortho-McNeil Pharmaceutical Corporation Full_Disclosure_Form.doc Page 3 of 6 NEI Full-Disclosure Form, continued continued Company Name Research Consultant Speakers Board Stock Other Divested? (producers of health care goods or services) / Grant / Advisor Bureau Member Ortho-McNeil Pharmaceutical, Inc. Otsuka America Pharmaceutical, Inc. Pamlab, L.L.C. (Pan American Laboratories, L.L.C.) Parke Davis Pharmaceuticals, Ltd. Pfizer Inc Pharmacia Corporation PharmaNeuroBoost N.V. Pierre Fabre Pierre Fabre Research Institute Prestwick Pharmaceuticals, Inc. The Procter & Gamble Company Promedix Purdue Pharma L.P. Quintiles Transnational Corp. Reevax Pharma Private Limited ResMed Inc. Respironics, Inc. Resteva Roche Pharmaceuticals Sandoz Inc. sanofi-aventis U.S. LLC Sanofi Pasteur Inc. Sanofi-Synthélabo Inc. Schering-Plough Corporation Dr. Willmar Schwabe Pharmaceuticals Schwarz Pharma Inc. Sepracor Inc. Servier Laboratories Shire Pharmaceuticals Inc. SK Bio-Pharmaceuticals SK Corporation Solvay Pharmaceuticals Somaxon Pharmaceuticals, Inc. Supernus Pharmaceuticals, Inc. Synaptic Pharmaceutical Corporation Syrex Takeda Pharmaceuticals North America, Inc. TAP Pharmaceutical Products Inc. Targacept, Inc. Tethys Pharmaceutical, Inc. Tetragenix Pharmaceuticals Full_Disclosure_Form.doc Page 4 of 6 NEI Full-Disclosure Form, continued continued Company Name Research Consultant Speakers Board Stock Other Divested? (producers of health care goods or services) / Grant / Advisor Bureau Member TransOral Pharmaceuticals, Inc. UCB Pharma, Inc Vanda Pharmaceuticals Inc. VivoMetrics, Inc. Wyeth Pharmaceuticals Wyeth Research Wyeth-Ayerst Laboratories Wyeth-Ayerst Pharmaceuticals XenoPort, Inc. Yamanouchi Pharmaceutical Company, Ltd. Full_Disclosure_Form.doc Page 5 of 6 NEI Full-Disclosure Form, continued Will any of the relationships identified above cause the information in the CME content you control to be Yes No commercially biased, or affect your ability to present well-balanced, evidence-based content? If you indicated financial relationships above, you must complete the following section for your disclosure to be considered completed. Mechanisms identified to resolve possible conflicts of interest. Please check all that apply: Presenters/Authors I will support my presentation and clinical recommendations with the “best available evidence” from the medical literature. (See suggested sources of best evidence at www.aafp.org/x3139.xml.) I will refrain from making recommendations regarding products or services, e.g., limit presentation to pathophysiology, diagnosis, and/or research findings. I will recommend an alternative presenter for this topic for the planning committee’s consideration. I will submit my presentation in advance to allow for adequate peer review. I will or have divested myself of this financial relationship. Planners To the best of my ability, I will ensure that any speakers or content I suggest are independent of commercial bias. I will recuse myself from planning activity content in which I have a conflict of interest. Additional information may be requested to resolve conflicts of interest. Please be advised that any potential conflicts of interest will be resolved for each activity on a case-by-case basis by NEI’s CME Advisory Board. Financial relationships will be disclosed to participants prior to the activity. DECLARATION 1. I will uphold academic standards to insure balance, independence, objectivity, and scientific rigor in my role in the planning, development, or presentation of all NEI CME activities. 2. I agree to comply with the requirements to protect health information under the Health Insurance Portability & Accountability Act of 1996. (HIPAA) 3. I will inform learners when I discuss or reference unapproved or unlabeled uses of therapeutic agents or products. Signature: ____________________________________________________________________________ Date: __________________ If you have questions about this policy, please contact NEI’s CME Department at: 888-535-5600. Please fax this completed form to CME’s attention at: 760-931-8713. Full_Disclosure_Form.doc Page 6 of 6 .
Recommended publications
  • Appendix a 2016 Financial Report Financial Review Pfizer Inc

    Appendix a 2016 Financial Report Financial Review Pfizer Inc

    Appendix A 2016 Financial Report Financial Review Pfizer Inc. and Subsidiary Companies GLOSSARY OF DEFINED TERMS Unless the context requires otherwise, references to “Pfizer,” “the Company,” “we,” “us” or “our” in this 2016 Financial Report (defined below) refer to Pfizer Inc. and its subsidiaries. We also have used several other terms in this 2016 Financial Report, most of which are explained or defined below: 2016 Financial Report This Financial Report for the fiscal year ended December 31, 2016, which was filed as Exhibit 13 to the Annual Report on Form 10-K for the fiscal year ended December 31, 2016 2016 Form 10-K Annual Report on Form 10-K for the fiscal year ended December 31, 2016 AAV Adeno-Associated Virus ABO Accumulated postretirement benefit obligation ACA (Also referred to as U.S. U.S. Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Healthcare Legislation) Act. ACIP Advisory Committee on Immunization Practices ALK anaplastic lymphoma kinase Allergan Allergan plc Alliance revenues Revenues from alliance agreements under which we co-promote products discovered or developed by other companies or us AM-Pharma AM-Pharma B.V. Anacor Anacor Pharmaceuticals, Inc. Astellas Astellas Pharma U.S. Inc. ASU Accounting Standards Update ATM-AVI aztreonam-avibactam Bamboo Bamboo Therapeutics, Inc. Baxter Baxter International Inc. BMS Bristol-Myers Squibb Company CDC U.S. Centers for Disease Control and Prevention Cellectis Cellectis SA Celltrion Celltrion Inc. and Celltrion Healthcare,
  • [Docket No. FDA-2017-N-3203] Wyeth Pharmaceutical

    [Docket No. FDA-2017-N-3203] Wyeth Pharmaceutical

    This document is scheduled to be published in the Federal Register on 06/21/2017 and available online at https://federalregister.gov/d/2017-12908, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-3203] Wyeth Pharmaceuticals Inc. et al.; Withdrawal of Approval of 121 New Drug Applications and 161 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 121 new drug applications (NDAs) and 161 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: The withdrawal is effective on [INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]. FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6248, Silver Spring, MD 20993-0002, 301-796-3601. SUPPLEMENTARY INFORMATION: The holders of the applications listed in table 1 in this document have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling. 2 Table 1 Application No.
  • 178S ASMS Directory of Members DAVID AASERUD the Lubrizol

    178S ASMS Directory of Members DAVID AASERUD the Lubrizol

    View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by Elsevier - Publisher Connector 178S ASMS Directory of Members DAVID AASERUD SUZANNE ACKLOO WILLIAM ADAMS The Lubrizol Corporation MDS Sciex Philip Morris USA 29400 Lakeland Blvd. 71 Four Valley Drive RD&E/OC-T3W Wickliffe, OH 44092 Concord, ON L4K 4V8 Canada 615 Maury Street Tel: 440 347 4776 Tel: 905 660 9005 Richmond, VA 23224 [email protected] [email protected] Tel: 804 274 2093 [email protected] SUSAN ABBATIELLO EUREKA ACOLATSE University of Florida 7237 Causeway Dr. #3B GARY E. ADAMSON Department of Chemistry Indianapolis, IN 46214 Merck and Co. PO Box 117200 Tel: 317 433 4016 Merch Research Laboratories Gainesville, FL 32611 [email protected] P.O. Box 4 Tel: 352 392 0536 West Point, PA 19486 [email protected] CHRIS ADAMS Tel: 215 652 1174 Uppsala University [email protected] LARRY ABBEY Biological & Medical Mass Spec Waters Corporation Box 583, BMC JULIE ADAMSON 4026 Oak Crest Drive Uppsala, SE-751 23 Sweden University of Michigan Tucker, GA 30084 Tel: 46 18 471 5729 930 N. University Tel: 770 414 5089 [email protected] Ann Arbor, MI 48109-1055 [email protected] Tel: 734-763-6535 GREG ADAMS [email protected] FRANK S. ABBOTT Diosynth Biotechnology University of British Columbia 3000 Weston Parkway TOM ADDISON Faculty of Pharmaceutical Science Cary, NC 27513 Covance-11 2146 East Mall Tel: 919 388 5690 6002/11 Vancouver, BC V6T 1Z3 Canada [email protected] 3301 Kinsman Boulevard Tel: 604 822 2566 Madison, WI 53704-2523 [email protected] LUKE ADAMS Tel: 608 242 2639 University of Washington, Chemistry [email protected] FADI ABDI Box 351700 Applied Biosystems Seattle, WA 98195 TERRI ADDONA 500 Old Connecticut Path Tel: 206 543 7656 Broad Instritute Framingham, MA 01702 [email protected] 320 Charles Street Tel: 508 383 7921 Cambridge, MA 02141 [email protected] NIGEL G.
  • 9894 Pharma Tech Media Planner V6 2007

    9894 Pharma Tech Media Planner V6 2007

    www.pharmtech.com years 1977– 2007 30ANNIVERSARY CELEBRATING 30 YEARS AS THE 2007 INDUSTRY’S MOST AUTHORITATIVE SOURCE Media Planner years 1977–2007 ANNIVERSARY years 1977–2007 ANNIVERSARY THE PHARMACEUTICAL TECHNOLOGY BRAND PUBLISHER’S STATEMENT Pharmaceutical Technology’s authoritative reputation and powerful brand recognition within the pharmaceutical/biopharmaceutical development & manufacturing marketplace will help you establish and maintain your own strong brand among pharma industry decision makers. A circulation of 38,667 BPA-qualified subscribers* and unmatched peer written and reviewed editorial make Pharmaceutical Technology an invaluable resource within top pharma companies, as well as small, specialty and biotech pharma companies spending billions each year on pharmaceutical development and manufacturing. Please celebrate with us as Pharmaceutical Technology marks its 30th Anniversary as the industry leader. —Michael Tracey, Publisher % 90 of readers rated Pharmaceutical Technology as important or very important to them as a professionalˆ EDITORIAL MISSION Pharmaceutical Technology publishes authoritative, reliable, and timely peer-reviewed research and expert analyses for scientists, engineers, technicians, and managers engaged in process development, manufacturing, formulation, analytical technology, packaging and regulatory compliance in the pharmaceutical and biotechnology industries. —Douglas McCormick, Editor in chief www.pharmtech.com *BPA June 2006 Statement ^2006 Readership Study Conducted by Advanstar Research
  • Amgen 2008 Annual Report and Financial Summary Pioneering Science Delivers Vital Medicines

    Amgen 2008 Annual Report and Financial Summary Pioneering Science Delivers Vital Medicines

    Amgen 2008 Annual Report and Financial Summary Pioneering science delivers vital medicines About Amgen Products Amgen discovers, develops, manufactures Aranesp® (darbepoetin alfa) and delivers innovative human therapeutics. ® A biotechnology pioneer since 1980, Amgen Enbrel (etanercept) was one of the fi rst companies to realize ® the new science’s promise by bringing EPOGEN (Epoetin alfa) safe and effective medicines from the lab Neulasta® (pegfi lgrastim) to the manufacturing plant to patients. NEUPOGEN® (Filgrastim) Amgen therapeutics have changed the practice of medicine, helping millions of Nplate® (romiplostim) people around the world in the fi ght against ® cancer, kidney disease, rheumatoid Sensipar (cinacalcet) arthritis and other serious illnesses, and so Vectibix® (panitumumab) far, more than 15 million patients worldwide have been treated with Amgen products. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. 0405 06 07 08 0405 06 07 08 0405 06 07 08 0405 06 07 08 Total revenues “Adjusted” earnings Cash fl ow from “Adjusted” research and ($ in millions) per share (EPS)* operations development (R&D) expenses* (Diluted) ($ in millions) ($ in millions) 2008 $15,003 2008 $4.55 2008 $5,988 2008 $2,910 2007 14,771 2007 4.29 2007 5,401 2007 3,064 2006 14,268 2006 3.90 2006 5,389 2006 3,191 2005 12,430 2005 3.20 2005 4,911 2005 2,302 2004 10,550 2004 2.40 2004 3,697 2004 1,996 * “ Adjusted” EPS and “adjusted” R&D expenses are non-GAAP fi nancial measures. See page 8 for reconciliations of these non-GAAP fi nancial measures to U.S.
  • AILERON THERAPEUTICS, INC. (Name of Registrant As Specified in Its Charter)

    AILERON THERAPEUTICS, INC. (Name of Registrant As Specified in Its Charter)

    Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☒ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Definitive Proxy Statement ☐ Definitive Additional Materials ☐ Soliciting Material Pursuant to §240.14a-12 AILERON THERAPEUTICS, INC. (Name of Registrant as Specified in Its Charter) (Name of Person(s) Filing Proxy Statement, if Other Than the Registrant) Payment of Filing Fee (Check the appropriate box): ☒ No fee required. ☐ Fee computed on table below per Exchange Act Rules 14a-6(i)(1) and 0-11. (1) Title of each class of securities to which transaction applies: (2) Aggregate number of securities to which transaction applies: (3) Per unit price or other underlying value of transaction computed pursuant to Exchange Act Rule 0-11 (set forth the amount on which the filing fee is calculated and state how it was determined): (4) Proposed maximum aggregate value of transaction: (5) Total fee paid: ☐ Fee paid previously with preliminary materials. ☐ Check box if any part of the fee is offset as provided by Exchange Act Rule 0-11(a)(2) and identify the filing for which the offsetting fee was paid previously. Identify the previous filing by registration statement number, or the Form or Schedule and the date of its filing. (1) Amount previously paid: (2) Form, Schedule or Registration Statement No.: (3) Filing Party: (4) Date Filed: Table of Contents AILERON THERAPEUTICS, INC.
  • UNITED STATES SECURITIES and EXCHANGE COMMISSION Form

    UNITED STATES SECURITIES and EXCHANGE COMMISSION Form

    Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 Form 10-K (Mark One) ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF ☒ 1934 For the fiscal year ended December 31, 2008 OR TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT ☐ OF 1934 Commission file number 000-12477 Amgen Inc. (Exact name of registrant as specified in its charter) Delaware 95-3540776 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) One Amgen Center Drive, 91320-1799 Thousand Oaks, California (Zip Code) (Address of principal executive offices) (805) 447-1000 (Registrant’s telephone number, including area code) Securities registered pursuant to Section 12(g) of the Act: Common stock, $0.0001 par value; preferred share purchase rights (Title of class) Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☒ No ☐ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒ Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or Section 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐ Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.
  • 1 United States District Court for the Southern District

    1 United States District Court for the Southern District

    Case 1:07-cv-12141-PBS Document 18-3 Filed 11/28/07 Page 1 of 167 UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF IOWA, CENTRAL DIVISION THE STATE OF IOWA, Plaintiff, v. ABBOTT LABORATORIES, INC., AGOURON PHARMACEUTICALS, INC., JURY TRIAL REQUESTED ALPHARMA, INC., ALZA CORPORATION, AMGEN, INC., ASTRAZENECA L.P., ASTRAZENECA PHARMACEUTICALS, LP., AVENTIS BEHRING L.L.C., COMPLAINT BARR LABORATORIES, INC., BAXTER INTERNATIONAL, INC., BAXTER HEALTHCARE CORPORATION, BAYER CORPORATION, BAYER PHARMACEUTICALS CORPORATION, BEN VENUE LABORATORIES, INC., BOEHRINGER INGELHEIM CORPORATION, BOEHRINGER INGELHEIM PHARMACEUTICALS, INC., BRISTOL-MYERS SQUIBB COMPANY, CENTOCOR, INC., CHIRON CORPORATION, DERMIK LABORATORIES, INC., DEY, INC., DEY, L.P., ELI LILLY AND COMPANY, EMD, INC., ENDO PHARMACEUTICALS, INC., ETHEX CORPORATION, ETHICON, INC., FOREST LABORATORIES, INC., FOREST PHARMACEUTICALS, INC. GENEVA PHARMACEUTICALS, GLAXOSMITHKLINE, PLC, GLAXOWELLCOME, INC., GREENSTONE, LTD., HOECHEST MARION ROIUSSEL, INC., HOFFMAN-LAROCHE, INC., 1 Case 1:07-cv-12141-PBS Document 18-3 Filed 11/28/07 Page 2 of 167 IMMUNEX CORPORATION, IVAX CORPORATION, IVAX PHARMACEUTICALS, INC., JANSSEN PHARMACEUTICA PRODUCTS, LP, JOHNSON & JOHNSON, KING PHARMACEUTICALS, INC., KING RESEARCH AND DEVELOPMENT, MCNEIL-PPC, INC., MEDIMMUNE, INC., MERCK & CO., INC., MONARCH PHARMACEUTICALS, INC., MYLAN LABORATORIES, INC., MYLAN PHARMACEUTICALS, INC., NOVARTIS PHARMACEUTICALS CORPORATION, NOVOPHARM USA, INC., ONCOLOGY THERAPEUTICS NETWORK CORP., ORTHO-MCNEIL PHARMACEUTICAL, INC.,
  • Reporte Anual

    Reporte Anual

    Clave de Cotización: ORBIA Fecha: 2019-12-31 [411000-AR] Datos generales - Reporte Anual Reporte Anual: Anexo N Oferta pública restringida: No Tipo de instrumento: Acciones,Deuda LP Emisora extranjera: No Mencionar si cuenta o no con aval u otra garantía, La emisión de Certificados Bursátiles se encuentra especificar la Razón o Denominación Social: avalada por las subsidiarias de la Compañía denominadas Mexichem Compuestos, S.A. de C.V., Mexichem Amanco Holding, S.A. de C.V., Mexichem Derivados, S.A. de C.V., Mexichem Resinas Vinílicas, S.A. de C.V., Mexichem Flúor, S.A. de C.V., y Mexichem Brasil Industria de Transformação Plástica Ltda. (“Mexichem Brasil”), esta última subsidiaria aval es una sociedad de nacionalidad brasileña y la totalidad de sus activos se encuentran ubicados fuera de México. De igual manera, en caso de insolvencia o quiebra de Mexichem Brasil, las reclamaciones de los Tenedores conforme a los Certificados Bursátiles quedarán sujetas a la preferencia que establezcan las leyes aplicables en la República Federal de Brasil. En su caso, detallar la dependencia parcial o total: No 1 de 209 Clave de Cotización: ORBIA Fecha: 2019-12-31 [412000-N] Portada reporte anual Orbia Advance Corporation, S.A.B. de C.V. Avenida Paseo de la Reforma 483, piso 47, Colonia Cuauhtémoc, Alcaldía Cuauhtémoc, Ciudad de México, 06500 Tel. 5366 4000 2 de 209 Clave de Cotización: ORBIA Fecha: 2019-12-31 Serie [Eje] I II Especificación de las características de los títulos en circulación [Sinopsis] Clase I II Serie Única Única Tipo Nominativa
  • Memorandum JUL 1 6 201D

    Memorandum JUL 1 6 201D

    Memorandum Subject Date Additional Quota Letters Received by July 15, 2010 (DFN: 630-08.2) JUL 1 6 201D To From Christine A. Sanncrud. Ph.D., Chief "Barbar• J.Illoockholdt, Chief Drug & Chemical Evaluation Section Regul• torn Section Office of Diverison Control Off cL rl Diversion Control On July 15. 2010, this section received your e-mail requesting a review of seventeen (17) quota applications from sixteen (16) registered manufacturers to determine if there arc any pending administrative/legal actions against these applicants and to advise ODE of the findings. ODOR conducted reviews (NADDIS, CSA, etc), as well as surveyed the responsible field offices for their input and recommendations. Provided below are the results and recommendations. QUOTA APPLICANTS wan NO ADVERSE OR DEROGATORY INFORMATIO N Novartis Consumer I lealth Lincoln (10345) (b)(4);(b)(7)(E) Baxter (10346) Generics Bidco li bda Vintage (10347) Noramco Delaware (10348) Pharmaceuticals International inc. (10349) Pharmedium (10351) Pharmedium (10352) Rhodes (10356) Bio-Pharm (10357) Patheon (10358) Patheon (10359) Watson (10361) B & B (10363) lospira. Inc. NC (10364) Epic Pharma (10366) Mallinckrodt I lobart (10367) Chemtos (10368) Vol. II Page 55 2 Per consultation with the field offices. DEA does not have sufficient grounds to limit, restrict. or deny quota requests from these registrants. Based on this information. ODG suggests that you proceed with the completion of the quota applications. If you have any questions pertaining to this information. please feel free to contact me (b)(6);(b)(7)( or SC C) (b)(6);(b)(7)(C) Vol. II Page 56 Memorandum Subject Date Additional Quota Letters Received as of July 19, 201() (DFN: 630-08.2) stir 2 8 2010,., To Fr ,./"./ Christine A.
  • Pharmaceutical Settlements

    Pharmaceutical Settlements

    Drug Patent Settlements Between Rivals: A Survey C. Scott Hemphill Columbia Law School Working paper available at ssrn.com/abstract=969492 March 12, 2007 Electronic copy of this paper is available at: http://ssrn.com/abstract=969492 Drug Patent Settlements Between Rivals: A Survey C. Scott Hemphill* Introduction .......................................................................................................................................... 3 I. Settlements in summary ........................................................................................................... 5 II. The mechanisms of payment for delay................................................................................. 13 A. Compensation to the generic firm............................................................................... 14 1. Cash and overpayment...................................................................................... 14 2. Preserving exclusivity........................................................................................ 16 3. Underpricing....................................................................................................... 18 4. Additional channels........................................................................................... 19 B. Delay in generic entry................................................................................................... 20 1. Neutralizing the first filer ................................................................................. 20 2. Bottleneck
  • 11/09/2016 Provider Subsystem Healthcare and Family Services Run Time: 20:25:21 Report Id 2794D051 Page: 01

    11/09/2016 Provider Subsystem Healthcare and Family Services Run Time: 20:25:21 Report Id 2794D051 Page: 01

    MEDICAID SYSTEM (MMIS) ILLINOIS DEPARTMENT OF RUN DATE: 11/09/2016 PROVIDER SUBSYSTEM HEALTHCARE AND FAMILY SERVICES RUN TIME: 20:25:21 REPORT ID 2794D051 PAGE: 01 NUMERIC COMPLETE LIST OF PHARMACEUTICAL LABELERS WITH SIGNED REBATE AGREEMENTS IN EFFECT AS OF 01/01/2017 NDC NDC PREFIX LABELER NAME PREFIX LABELER NAME 00002 ELI LILLY AND COMPANY 00145 STIEFEL LABORATORIES, INC, 00003 E.R. SQUIBB & SONS, LLC. 00149 WARNER CHILCOTT PHARMACEUTICALS INC. 00004 HOFFMANN-LA ROCHE 00168 E FOUGERA AND CO. 00006 MERCK & CO., INC. 00169 NOVO NORDISK, INC. 00007 GLAXOSMITHKLINE 00172 IVAX PHARMACEUTICALS, INC. 00008 WYETH LABORATORIES 00173 GLAXOSMITHKLINE 00009 PFIZER, INC 00178 MISSION PHARMACAL COMPANY 00013 PFIZER, INC. 00182 GOLDLINE LABORATORIES, INC. 00015 MEAD JOHNSON AND COMPANY 00185 EON LABS, INC. 00023 ALLERGAN INC 00186 ASTRAZENECA LP 00024 SANOFI-AVENTIS, US LLC 00187 VALEANT PHARMACEUTICALS NORTH AMERICA 00025 PFIZER, INC. 00206 LEDERLE PIPERACILLIN 00026 BAYER HEALTHCARE LLC 00224 KONSYL PHARMACEUTICALS, INC. 00029 GLAXOSMITHKLINE 00225 B. F. ASCHER AND COMPANY, INC. 00032 SOLVAY PHARMACEUTICALS, INC. 00228 ACTAVIS ELIZABETH LLC 00037 MEDA PHARMACEUTICALS, INC. 00245 UPSHER-SMITH LABORATORIES, INC. 00039 SANOFI-AVENTIS, US LLC 00258 FOREST LABORATORIES INC 00046 AYERST LABORATORIES 00259 MERZ PHARMACEUTICALS 00049 PFIZER, INC 00264 B. BRAUN MEDICAL INC. 00051 UNIMED PHARMACEUTICALS, INC 00281 SAVAGE LABORATORIES 00052 ORGANON USA INC. 00299 GALDERMA LABORATORIES, L.P. 00053 CSL BEHRING 00300 TAP PHARMACEUTICALS INC 00054 ROXANE LABORATORIES, INC. 00310 ASTRAZENECA LP 00056 BRISTOL-MYERS SQUIBB PHARMA CO. 00327 GUARDIAN LABS DIV UNITED-GUARDIAN INC 00062 ORTHO MCNEIL PHARMACEUTICALS 00338 BAXTER HEALTHCARE CORPORATION 00064 HEALTHPOINT, LTD. 00378 MYLAN PHARMACEUTICALS, INC.