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Otonomy Inc. 2021 Proxy Statement
OTONOMY, INC. Dear Stockholder: I am pleased to invite you to attend the 2021 Annual Meeting of Stockholders (the “Annual Meeting”) of Otonomy, Inc. (“Otonomy”), which will be held on June 22, 2021 at 8:00 a.m. Pacific Time. The Annual Meeting will be conducted virtually via live webcast. You will be able to attend the Annual Meeting by visiting www.virtualshareholdermeeting.com/OTIC2021, where you will be able to listen to the meeting live, submit questions and vote online by entering the control number located on your proxy card. The attached Notice of Annual Meeting of Stockholders and proxy statement contain details of the business to be conducted at the Annual Meeting. Whether or not you attend the Annual Meeting, it is important that your shares be represented and voted at the meeting. Therefore, I urge you to promptly vote and submit your proxy via the Internet, by phone, or by signing, dating and returning the enclosed proxy card in the enclosed envelope. If you decide to attend the Annual Meeting, you will be able to change your vote or revoke your proxy, even if you have previously submitted your proxy. On behalf of Otonomy, I would like to thank you for your continued support. Sincerely, David A. Weber, Ph.D. President and Chief Executive Officer OTONOMY, INC. 4796 Executive Drive San Diego, California 92121 NOTICE OF ANNUAL MEETING OF STOCKHOLDERS Time and Date June 22, 2021 at 8:00 a.m. Pacific Time The Annual Meeting will be a completely virtual meeting of stockholders, to be conducted via live webcast. -
“Ablueprintforbuildingonesandiego”
“A Blueprint for Building One San Diego” Mayor Kevin L. Faulconer 1 TRANSITION ADVISORY COMMITTEE RECOMMENDATIONS June 12, 2014 The Office of the Mayor would like to thank the following members of the One San Diego Transition Advisory Committee for volunteering their time to reviewing materials, attending meetings and providing valuable input for this report. ONE SAN DIEGO TRANSITION ADVISORY COMMITTEE CHAIRS Stephen Cushman Tony Young MEMBERS Susie Baumann Ben Katz Faith Bautista Leslie Kilpatrick Sam Bedwell Ure Kretowicz Blanca Lopez Brown Pastor Rick Laster Mark Cafferty Elyse Lowe Dr. Constance M. Carroll Lani Lutar Father Joe Carroll William D. Lynch Sharon Cloward Tony Manolatos Byeong Dae Kim Cindy Marten Aimee Faucett Brian Marvel Randy Frisch Vincent E. Mudd Ronne Froman Nicole Murray-Ramirez Gary Gallegos Bob Nelson Rick Gentry Joseph D. Panetta Bill Geppert Dan Stoneman Robert Gleason Russ Thurman Jeff Graham Rick Valencia Abdur-Rahim Hameed Kristen Victor Dan Hom Reverend Walter G. Wells Jennifer Jacobs Faye Wilson Tracy Jarman Christopher Yanov Susan Jester Barbara Ybarra Jeff Johnson Michael Zucchet 2 ONE SAN DIEGO TRANSITION ADVISORY COMMITTEE Table of Contents Executive Summary .................................................................................. 4 Subcommittee Reports ............................................................................. 7 Education & Youth Opportunity ............................................................ 7 Homeless & Housing Affordability ................................................... -
Pharmaceuticals, Medical Devices and Biologics Regulatory and Policy Bulletin
Antitrust Connection Spring 2009 To: Our Clients and Friends August 27, 2010 Pharmaceuticals, Medical Devices and Biologics Regulatory and Policy Bulletin Top News During China Visit, FDA Commissioner’s Focus Not on Heparin Investigation FDA Commissioner Margaret Hamburg’s recent trip to China focused primarily on avenues of collaboration and cooperation between the FDA and Chinese regulators rather than on the current investigation into the contamination of heparin, which has caused some to express concern that US legislators may perceive the two bodies as not trying to work effectively to determine the cause of the contamination. FDA officials have indicated that the issue was discussed, but it was not focused on during the meetings. Industry Expresses Concern Over New Drug User Fees The drug industry is expressing concern over the FDA’s recent increase in prescription drug user fee rates, saying that the increase of approximately 10 percent is not appropriate given the backlog and failure to meet other review deadlines. Industry has indicated that it would like more accountability and adherence to performance goals if will be paying such increased fees. As the FDA discusses drug user fees and other programs as part of the Prescription Drug User Fee Act legislative proposal, some consumer, safety, and patient groups are voicing their concern that the agency is not including them in its discussions of the Act. Official, Panel Members Criticize Glaxo’s Report on Avandia Committee Meeting An article in the New York Times indicates that a government official and some members of the FDA advisory panel that recently reviewed Avandia are critical of Glaxo’s letter to doctors participating in the TIDE trial, intended to compare the risks of Avandia with those of competing drug Actos. -
Saturday, May 12
Wednesday,2018 May 9 – Saturday, May 12 – LINK Presenting Sponsors – LINK 2018 – San Diego Region Dear LINK Participants, Welcome to the 22nd LINK program. The purpose of LINK is to expose you, first-hand, to the successes and challenges of other metropolitan areas, while providing networking opportunities with leaders from the region we visit, as well as leaders from our own region. This year we travel to the San Diego region. Known for its innovation economy and beautiful natural environment, San Diego is uniquely located on the U.S.-Mexico border, and shares deep economic and cultural ties with Tijuana. With these great assets come challenges, including an increasing housing affordability and homelessness crisis. Home to a large concentration of U.S. Navy and U.S. Marine Corps troops and installations, the region’s long military roots drew researchers and innovators in communications technology to the region. San Diego leaders also actively recruited life sciences and biotechnology research institutions, further solidifying the region’s innovation economy. We will see the richness of San Diego’s economy and the workforce development work underway to support it, while also hearing from leaders of the innovation and defense sectors. We will also see the region’s challenges in providing enough housing for all San Diegans. Affordability is a challenge across many income levels, and homelessness is growing. Through a series of tours, presentations and panel discussions, LINK participants will explore various topics in the San Diego region, including those mentioned above and many more. It is our hope that the 2018 LINK trip will provide you with fresh ideas and new insights for addressing the issues and opportunities we face back home, such as workforce development and our increasing challenge of housing affordability. -
Comprehensive Annual Financial Report
COMPREHENSIVE ANNUAL FINANCIAL REPORT For Fiscal Year Ended June 30, 2020 COMPREHENSIVE ANNUAL FINANCIAL REPORT For Fiscal Year Ended June 30, 2020 Prepared by the Finance Department San Diego, California 92123 Helix WATER DISTRICT CITY OF * * The Sweetwater Authority is a service organization for the City of National City and the South Bay Irrigation District. Introductory Section Letter of Transmittal ............................................................................................................................... 1 Awards and Acknowledgements ........................................................................................................... 17 San Diego County Water Authority Board of Directors ....................................................................... 19 San Diego County Water Authority Organizational Structure .............................................................. 20 Financial Section Independent Auditor’s Report ............................................................................................................... 21 Management’s Discussion and Analysis (Required Supplementary Information) ...................... 25 Financial Statements Statement of Net Position ..................................................................................................................... 35 Statement of Revenues, Expenses, and Changes in Net Position ......................................................... 36 Statement of Cash Flows ...................................................................................................................... -
Proposed Hotel Santee
MARKET STUDY Proposed Hotel Santee RIVERVIEW PARKWAY SANTEE, CALIFORNIA SUBMITTED TO:PROPOSED PREPARED BY: Ms. Pamela White HVS Consulting & Valuation City of Santee Division of TS Worldwide, LLC 10601 Magnolia Avenue 100 Bush Street, Suite 1625 Santee, California 92071 San Francisco, California 94104 +1 (619) 258-4100 ext. 223 +1 (415) 896-0868 July‐2018 September 10, 2018 Ms. Pamela White City of Santee 10601 Magnolia Avenue Santee, California 92071 HVS SAN FRANCISCO Re: Hotel Market Analysis 100 Bush Street, Suite 1625 San Francisco, California, 94104 Santee, California +1 (415) 896‐0868 HVS Reference: 2017021673 +1 (415) 896‐0516 FAX www.hvs.com Dear Ms. White: Pursuant to your request, please find attached our study of the Santee, California, hotel market. Our investigation reveals that the market has the potential to support new hotel development. This engagement addresses market demand for new hotel development; no analysis of financial feasibility has been undertaken. We hereby certify that we have no undisclosed interest in the property, and our employment and compensation are not contingent upon our findings. This study is subject to the comments made throughout this report and to all assumptions and limiting conditions set forth herein. Sincerely, TS Worldwide, LLC Suzanne R. Mellen, MAI, CRE, FRICS, ISHC, Senior Managing Director - Practice Leader [email protected], +1 (415) 268-0351 McKenna K. Luke, MAI Director [email protected], +1 (303) 704-2636 Superior results through unrivaled hospitality intelligence. Everywhere. Table of Contents SECTION TITLE PAGE 1. Executive Summary 4 2. Market Area Analysis 9 3. Hotel Supply and Demand Analysis 31 4. -
204200Orig1s000 204200Orig2s000
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 204200Orig1s000 204200Orig2s000 MEDICAL REVIEW(S) CLINICAL REVIEW Application Type NDA Application Number(s) 204-200 and 204-640 Priority or Standard Standard Submit Date(s) March 7, 2012 Received Date(s) March 7, 2012 PDUFA Goal Date January 7, 2013 Division / Office DPARP/OND Reviewer Name(s) Peter Starke, MD Review Completion Date October 29, 2012 Established Name Epinephrine injection, USP, 1mg/mL (Proposed) Trade Name Adrenalin® Therapeutic Class Catecholamine Applicant JHP Pharmaceuticals, LLC Formulation(s) Solution for injection Proposed Dosing Hypersensitivity reactions: IM or SC Regimen injection(b) (4) [Ophthalmic use: Topical irrigation or intraocular bolus injection] Proposed Indication(s) Hypersensitivity reactions: severe acute anaphylactic reactions, (b) (4) [Ophthalmic use: induction and maintenance of mydriasis during cataract surgery] Intended Population(s) Hypersensitivity reactions: No age restrictions [Ophthalmic use: No age restrictions] Reference ID: 3209828 Clinical Review ● Peter Starke, MD NDA 204-200 ● Adrenalin® (epinephrine) MEDICAL OFFICER REVIEW Division of Pulmonary, Allergy and Rheumatology Products (DPARP) SUBMISSIONS REVIEWED IN THIS DOCUMENT Document Date CDER Stamp Date Submission Comments March 7, 2012 March 7, 2012 SD-1, eCTD-0000 New NDA submission April 9, 2012 April 9, 2012 SD-2, eCTD-0001 PREA waiver request – Anaphylaxis April 9, 2012 April 9, 2012 SD-3, eCTD-0002 PREA waiver request – Mydriasis April 18, 2012 April 18, 2012 SD-4, eCTD-0003 Request for proprietary name review Sept 5, 2012 Sept 6, 2012 SD-22, eCTD-0021 Draft Ophthalmic Labeling Oct 22, 2012 Oct 22, 2012 SD-27, eCDT-0026 Certification that EpiPen is the reference for the 505(b)(2) application RECOMMENDED REGULATORY ACTION NDA/SUPPLEMENTS: X APPROVAL COMPLETE RESPONSE OTHER ACTION: 2 Reference ID: 3209828 Clinical Review ● Peter Starke, MD NDA 204-200 ● Adrenalin® (epinephrine) Table of Contents 1 RECOMMENDATIONS/RISK BENEFIT ASSESSMENT ........................................ -
Comprehensive Annual Financial Report
COMPREHENSIVE ANNUAL FINANCIAL REPORT FOR THE FISCAL YEAR ENDED JUNE 30, 2018 cover design by m.wojcik COMPREHENSIVE ANNUAL FINANCIAL REPORT FOR THE FISCAL YEAR ENDED JUNE 30, 2018 San Diego, California 92123 Prepared by the Finance Department This page intentionally left blank. Comprehensive Annual Financial Report Fiscal Year Ended June 30, 2018 Table of Contents Introductory Section Letter of Transmittal ..................................................................................................................................... 1 Awards and Acknowledgements ................................................................................................................ 12 San Diego County Water Authority Board of Directors .......................................................................... 14 San Diego County Water Authority Organizational Structure ................................................................ 15 Financial Section Independent Auditor’s Report .................................................................................................................... 17 Management’s Discussion and Analysis (Required Supplementary Information) .......................21 Financial Statements Statement of Net Position ........................................................................................................................... 31 Statement of Revenues, Expenses, and Changes in Net Position ............................................................ 32 Statement of Cash Flows ........................................................................................................................... -
Health Sciences San Diego 1.0 Prepared By
Health Sciences San Diego 1.0 Prepared By: CSUSM FEMBA Cohort Class 2016 Fall 2015 Health Sciences San Diego 1.0 Table of Contents TABLE OF TABLES III 1. EXECUTIVE SUMMARY IV 1.1. KEY DEMOGRAPHICS 1 2. HEALTHCARE INDUSTRY ERROR! BOOKMARK NOT DEFINED. 2.1. KEY PLAYERS 3 2.1.1. UC SAN DIEGO HEALTH 3 2.1.2. SCRIPPS HEALTHCARE 5 2.1.3. KAISER PERMANENTE 5 2.1.4. SHARP HEALTHCARE 5 2.1.5. VETERANS AFFAIRS 6 2.1.6. OTHER HEALTHCARE PROVIDERS 6 2.2. CRITICAL FACTORS 6 2.3. KEY PLAYER INTERACTIONS IN SAN DIEGO 8 2.4. INDUSTRY DEVELOPMENT 10 2.4.1. FACILITIES AND EXPANSION 10 2.4.2. HEALTHCARE INFORMATION TECHNOLOGY (HIT) 11 2.5. INDUSTRY CHALLENGES 12 3. BIOTECHNOLOGY INDUSTRY 15 3.1. CRITICAL FACTORS 15 3.2. KEY PLAYERS 18 3.2.1. THERMO FISHER 18 3.2.2. ILLUMINA 18 3.2.3. PFIZER 19 3.2.4. JOHNSON & JOHNSON 20 3.2.5. NOVARTIS 21 3.3. KEY PLAYER INTERACTIONS IN SAN DIEGO 21 3.4. INDUSTRY DEVELOPMENT 24 3.4.1. INDUSTRY TRENDS – BIOTECHNOLOGY 24 3.4.2. INDUSTRY TRENDS – PHARMACEUTICAL 26 3.4.3. INDUSTRY TRENDS – DIAGNOSTICS 27 3.5. INDUSTRY CHALLENGES 27 3.5.1. COMPETITION OF BIOTECH AND PHARMACEUTICAL IN SAN DIEGO 28 3.5.2. FUNDING, TAXES, AND REGULATION OF BIOTECH AND PHARMACEUTICAL IN SAN DIEGO 28 4. BIOMEDICAL DEVICES INDUSTRY 30 HSSD 1.0 Page i Health Sciences San Diego 1.0 4.1. CRITICAL FACTORS 30 4.2. KEY PLAYERS 33 4.2.1. -
Lesson 3 San Diego's Economy
Lesson 4: San Diego’s Economy Focus Question: What are the largest industries in San Diego’s economy? The top four industries in San Diego County are manufacturing, defense, tourism, and agriculture. In addition, the City of San Diego focuses on six main industry clusters: Biotechnology/Biosciences Financial and Business Services Defense and Space Manufacturing Software Electronics Manufacturing Telecommunications San Diego's economy, once dominated by military and defense endeavors is led by manufacturing, particularly in the areas of shipbuilding and repair, industrial machinery and computers, metals production, and the manufacture of toys and sporting goods. International trade is an important part of San Diego's economy. The border between the San Diego area and Tijuana is the busiest in the world. Since the founding of San Diego, the city's economy has been tied to San Diego Bay. Today, it is an important link in the nation's international shipping trade and the port also has a growing cruise ship operation, with more than 180 cruise ships docking annually. San Diego's harbor has had the most significant impact on the local economy, however, through the Eleventh Naval District Headquarters, the base for the U.S. Navy Pacific fleet, which is located on the bay. San Diego is the Navy's principal location for West Coast and Pacific Ocean operations. The military/defense industry is the city's second largest economic sector. It includes high-technology research, development, and engineering in satellite communications systems, electronic systems, unmanned aerial vehicles, propulsion systems, deep space cameras, satellites, rugged military computers and displays, and robotic roving vehicles. -
UNITED STATES SECURITIES and EXCHANGE COMMISSION Washington, D.C
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 under §240.14a-12 Phathom Pharmaceuticals, 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: 100 Campus Drive, Suite 102 Florham Park, NJ 07932 NOTICE OF ANNUAL MEETING OF STOCKHOLDERS AND PROXY STATEMENT Dear Stockholder: The annual meeting of stockholders of Phathom Pharmaceuticals, Inc. -
Case 3:17-Cv-05244 Document 1 Filed 04/03/17 Page 1 of 100
Case 3:17-cv-05244 Document 1 Filed 04/03/17 Page 1 of 100 1 2 3 4 5 6 7 UNITED STATES DISTRICT COURT, WESTERN DISTRICT OF WASHINGTON AT SEATTLE 8 9 AMBER RAINEY, CHRISTINA KOLLMEYER, and LISA VOGEL, 10 No. Plaintiffs, 11 COMPLAINT v. 12 MYLAN SPECIALTY, L.P., a Delaware 13 limited partnership, 14 Defendant. 15 16 17 18 19 20 21 22 23 24 25 26 27 28 COMPLAINT Case No. 1918 EIGHTH AVENUE, SUITE 3300 • SEATTLE, WA 98101 (206) 623-7292 • FAX (206) 623-0594 010648.11 949197 V1 Case 3:17-cv-05244 Document 1 Filed 04/03/17 Page 2 of 100 1 TABLE OF CONTENTS 2 Page 3 I. INTRODUCTION ...............................................................................................................1 4 II. PARTIES .............................................................................................................................7 5 A. Plaintiffs ...................................................................................................................7 6 B. Defendant .................................................................................................................8 7 III. JURISDICTION AND VENUE ..........................................................................................8 8 IV. DRUG PRICING IN THE UNITED STATES ....................................................................9 9 A. The Entities Involved in Drug Pricing .....................................................................9 10 B. Different Prices for Different Players ....................................................................10