This document is a joint appendix of trial evidence from a case between Recro Gainesville LLC and Actavis Laboratories FL, Inc. in the United States District Court for the District of Delaware. It contains a list of 75 exhibits, including patents, study reports, test results, and other documents that were submitted as evidence during the trial. The exhibits relate to hydrocodone bitartrate extended release capsules and include Actavis's ANDA and product development reports as well as studies evaluating the pharmacokinetic properties and bioequivalence of Actavis's generic product compared to the branded drug.
Jpml1testosterone low testerone litigaiton brief in support of transfermzamoralaw
Testosterone and Low-T Drugs Under Investigation
AndroGel - Manufactured by AbbVie
AndroDerm - Manufactured by Actavis
Axiron - Manufactured by Eli Lilly and Company
Bio-T-Gel - Manufactured by Teva Pharmaceuticals
Fortesta - Manufactured by Endo Pharmaceuticals
Striant - Manufactured by Columbia Laboratories
Testim - Manufactured by Auxilium Pharmaceuticals
Testopel - Manufactured by Auxilium Pharmaceuticals
Delatestryl - Manufactured by Indevus Pharmaceuticals
Depo-Testosterone - Manufactured by Pharmacia & Upjohn Company
HIV Alert:Emerging Updates on Dual Therapy.2018hivlifeinfo
In this downloadable slideset, Joseph J. Eron, Jr., MD, and Babafemi Taiwo, MBBS, provide expert insight into the use of a recently-approved dual-therapy regimen and review data surrounding investigational two-drug regimens.
Format: Microsoft PowerPoint (.ppt)
File size: 375 KB
Date posted: 1/5/2018
5. Frank Buttgereit. Fin40 min rheumatic diseases and osteoporosiscrea-autoinmunidad
This document discusses secondary osteoporosis, glucocorticoid-induced osteoporosis, and emerging drugs for osteoporosis. It summarizes recent findings on the relationship between bone mass and atherosclerosis in systemic lupus erythematosus patients. It also discusses the high prevalence of osteoporosis in ankylosing spondylitis patients and recommendations for assessing osteoporosis in these patients. Finally, it reviews glucocorticoid use and comorbidities in giant cell arteritis patients and the contribution of both disease and glucocorticoid treatment to osteoporosis risk in these patients.
The document discusses a biotechnology company focused on developing products that regenerate or strengthen the human immune system. It summarizes results showing that the company's drug candidate Homspera stimulates hematopoietic stem cells, increasing white blood cell and platelet production. Studies also suggest Homspera may help resolve neutropenia caused by radiation exposure and chemotherapy by boosting white blood cell counts in irradiated animals.
Recro vs Actavis Zohydro Case Memorandum - Filed 02/22/17Andrew Cunningham
Case 1:14-cv-01118-GMS
(1) Actavis' proposed ANDA products infringe all of the asserted claims of the '096 patent; and
(2) Actavis' proposed ANDA products infringe all of the asserted claims of the '742 patent.
Case 1:14-cv-01118 Recro Vs Actavis - Actavis' Conclusions of lawAndrew Cunningham
The document appears to be a court filing related to a case numbered 1:14-cv-01118-GMS. It consists of 40 numbered pages and references an order or ruling issued on November 14, 2016 related to the named parties and case issues. However, without more context around the specific case, details of the parties, issues or ruling referenced in the 40 pages cannot be determined from the document alone in only 3 sentences.
Chris Clark, the CFO of Neovasc Inc. and a director of Neovasc Tiara Inc., submitted a declaration in a patent infringement case between Cardiaq Valve Technologies and Neovasc. In the declaration, Clark stated that Neovasc entered an agreement to sell its tissue processing technology and facility to Boston Scientific for $75 million, and that Neovasc has budgeted financially to last through 18 months of anticipated further legal proceedings. Contingent on closing the Boston Scientific deal, Neovasc offered $40.6 million as a partial bond pending appeal in the case.
Jpml1testosterone low testerone litigaiton brief in support of transfermzamoralaw
Testosterone and Low-T Drugs Under Investigation
AndroGel - Manufactured by AbbVie
AndroDerm - Manufactured by Actavis
Axiron - Manufactured by Eli Lilly and Company
Bio-T-Gel - Manufactured by Teva Pharmaceuticals
Fortesta - Manufactured by Endo Pharmaceuticals
Striant - Manufactured by Columbia Laboratories
Testim - Manufactured by Auxilium Pharmaceuticals
Testopel - Manufactured by Auxilium Pharmaceuticals
Delatestryl - Manufactured by Indevus Pharmaceuticals
Depo-Testosterone - Manufactured by Pharmacia & Upjohn Company
HIV Alert:Emerging Updates on Dual Therapy.2018hivlifeinfo
In this downloadable slideset, Joseph J. Eron, Jr., MD, and Babafemi Taiwo, MBBS, provide expert insight into the use of a recently-approved dual-therapy regimen and review data surrounding investigational two-drug regimens.
Format: Microsoft PowerPoint (.ppt)
File size: 375 KB
Date posted: 1/5/2018
5. Frank Buttgereit. Fin40 min rheumatic diseases and osteoporosiscrea-autoinmunidad
This document discusses secondary osteoporosis, glucocorticoid-induced osteoporosis, and emerging drugs for osteoporosis. It summarizes recent findings on the relationship between bone mass and atherosclerosis in systemic lupus erythematosus patients. It also discusses the high prevalence of osteoporosis in ankylosing spondylitis patients and recommendations for assessing osteoporosis in these patients. Finally, it reviews glucocorticoid use and comorbidities in giant cell arteritis patients and the contribution of both disease and glucocorticoid treatment to osteoporosis risk in these patients.
The document discusses a biotechnology company focused on developing products that regenerate or strengthen the human immune system. It summarizes results showing that the company's drug candidate Homspera stimulates hematopoietic stem cells, increasing white blood cell and platelet production. Studies also suggest Homspera may help resolve neutropenia caused by radiation exposure and chemotherapy by boosting white blood cell counts in irradiated animals.
Recro vs Actavis Zohydro Case Memorandum - Filed 02/22/17Andrew Cunningham
Case 1:14-cv-01118-GMS
(1) Actavis' proposed ANDA products infringe all of the asserted claims of the '096 patent; and
(2) Actavis' proposed ANDA products infringe all of the asserted claims of the '742 patent.
Case 1:14-cv-01118 Recro Vs Actavis - Actavis' Conclusions of lawAndrew Cunningham
The document appears to be a court filing related to a case numbered 1:14-cv-01118-GMS. It consists of 40 numbered pages and references an order or ruling issued on November 14, 2016 related to the named parties and case issues. However, without more context around the specific case, details of the parties, issues or ruling referenced in the 40 pages cannot be determined from the document alone in only 3 sentences.
Chris Clark, the CFO of Neovasc Inc. and a director of Neovasc Tiara Inc., submitted a declaration in a patent infringement case between Cardiaq Valve Technologies and Neovasc. In the declaration, Clark stated that Neovasc entered an agreement to sell its tissue processing technology and facility to Boston Scientific for $75 million, and that Neovasc has budgeted financially to last through 18 months of anticipated further legal proceedings. Contingent on closing the Boston Scientific deal, Neovasc offered $40.6 million as a partial bond pending appeal in the case.
What are the common challenges faced by women lawyers working in the legal pr...lawyersonia
The legal profession, which has historically been male-dominated, has experienced a significant increase in the number of women entering the field over the past few decades. Despite this progress, women lawyers continue to encounter various challenges as they strive for top positions.
Sangyun Lee, 'Why Korea's Merger Control Occasionally Fails: A Public Choice ...Sangyun Lee
Presentation slides for a session held on June 4, 2024, at Kyoto University. This presentation is based on the presenter’s recent paper, coauthored with Hwang Lee, Professor, Korea University, with the same title, published in the Journal of Business Administration & Law, Volume 34, No. 2 (April 2024). The paper, written in Korean, is available at <https://shorturl.at/GCWcI>.
Guide on the use of Artificial Intelligence-based tools by lawyers and law fi...Massimo Talia
This guide aims to provide information on how lawyers will be able to use the opportunities provided by AI tools and how such tools could help the business processes of small firms. Its objective is to provide lawyers with some background to understand what they can and cannot realistically expect from these products. This guide aims to give a reference point for small law practices in the EU
against which they can evaluate those classes of AI applications that are probably the most relevant for them.
Matthew Professional CV experienced Government LiaisonMattGardner52
As an experienced Government Liaison, I have demonstrated expertise in Corporate Governance. My skill set includes senior-level management in Contract Management, Legal Support, and Diplomatic Relations. I have also gained proficiency as a Corporate Liaison, utilizing my strong background in accounting, finance, and legal, with a Bachelor's degree (B.A.) from California State University. My Administrative Skills further strengthen my ability to contribute to the growth and success of any organization.
Synopsis On Annual General Meeting/Extra Ordinary General Meeting With Ordinary And Special Businesses And Ordinary And Special Resolutions with Companies (Postal Ballot) Regulations, 2018
This document briefly explains the June compliance calendar 2024 with income tax returns, PF, ESI, and important due dates, forms to be filled out, periods, and who should file them?.
Lifting the Corporate Veil. Power Point Presentationseri bangash
"Lifting the Corporate Veil" is a legal concept that refers to the judicial act of disregarding the separate legal personality of a corporation or limited liability company (LLC). Normally, a corporation is considered a legal entity separate from its shareholders or members, meaning that the personal assets of shareholders or members are protected from the liabilities of the corporation. However, there are certain situations where courts may decide to "pierce" or "lift" the corporate veil, holding shareholders or members personally liable for the debts or actions of the corporation.
Here are some common scenarios in which courts might lift the corporate veil:
Fraud or Illegality: If shareholders or members use the corporate structure to perpetrate fraud, evade legal obligations, or engage in illegal activities, courts may disregard the corporate entity and hold those individuals personally liable.
Undercapitalization: If a corporation is formed with insufficient capital to conduct its intended business and meet its foreseeable liabilities, and this lack of capitalization results in harm to creditors or other parties, courts may lift the corporate veil to hold shareholders or members liable.
Failure to Observe Corporate Formalities: Corporations and LLCs are required to observe certain formalities, such as holding regular meetings, maintaining separate financial records, and avoiding commingling of personal and corporate assets. If these formalities are not observed and the corporate structure is used as a mere façade, courts may disregard the corporate entity.
Alter Ego: If there is such a unity of interest and ownership between the corporation and its shareholders or members that the separate personalities of the corporation and the individuals no longer exist, courts may treat the corporation as the alter ego of its owners and hold them personally liable.
Group Enterprises: In some cases, where multiple corporations are closely related or form part of a single economic unit, courts may pierce the corporate veil to achieve equity, particularly if one corporation's actions harm creditors or other stakeholders and the corporate structure is being used to shield culpable parties from liability.
2024 State of Marketing Report – by HubspotMarius Sescu
https://www.hubspot.com/state-of-marketing
· Scaling relationships and proving ROI
· Social media is the place for search, sales, and service
· Authentic influencer partnerships fuel brand growth
· The strongest connections happen via call, click, chat, and camera.
· Time saved with AI leads to more creative work
· Seeking: A single source of truth
· TLDR; Get on social, try AI, and align your systems.
· More human marketing, powered by robots
ChatGPT is a revolutionary addition to the world since its introduction in 2022. A big shift in the sector of information gathering and processing happened because of this chatbot. What is the story of ChatGPT? How is the bot responding to prompts and generating contents? Swipe through these slides prepared by Expeed Software, a web development company regarding the development and technical intricacies of ChatGPT!
What are the common challenges faced by women lawyers working in the legal pr...lawyersonia
The legal profession, which has historically been male-dominated, has experienced a significant increase in the number of women entering the field over the past few decades. Despite this progress, women lawyers continue to encounter various challenges as they strive for top positions.
Sangyun Lee, 'Why Korea's Merger Control Occasionally Fails: A Public Choice ...Sangyun Lee
Presentation slides for a session held on June 4, 2024, at Kyoto University. This presentation is based on the presenter’s recent paper, coauthored with Hwang Lee, Professor, Korea University, with the same title, published in the Journal of Business Administration & Law, Volume 34, No. 2 (April 2024). The paper, written in Korean, is available at <https://shorturl.at/GCWcI>.
Guide on the use of Artificial Intelligence-based tools by lawyers and law fi...Massimo Talia
This guide aims to provide information on how lawyers will be able to use the opportunities provided by AI tools and how such tools could help the business processes of small firms. Its objective is to provide lawyers with some background to understand what they can and cannot realistically expect from these products. This guide aims to give a reference point for small law practices in the EU
against which they can evaluate those classes of AI applications that are probably the most relevant for them.
Matthew Professional CV experienced Government LiaisonMattGardner52
As an experienced Government Liaison, I have demonstrated expertise in Corporate Governance. My skill set includes senior-level management in Contract Management, Legal Support, and Diplomatic Relations. I have also gained proficiency as a Corporate Liaison, utilizing my strong background in accounting, finance, and legal, with a Bachelor's degree (B.A.) from California State University. My Administrative Skills further strengthen my ability to contribute to the growth and success of any organization.
Synopsis On Annual General Meeting/Extra Ordinary General Meeting With Ordinary And Special Businesses And Ordinary And Special Resolutions with Companies (Postal Ballot) Regulations, 2018
This document briefly explains the June compliance calendar 2024 with income tax returns, PF, ESI, and important due dates, forms to be filled out, periods, and who should file them?.
Lifting the Corporate Veil. Power Point Presentationseri bangash
"Lifting the Corporate Veil" is a legal concept that refers to the judicial act of disregarding the separate legal personality of a corporation or limited liability company (LLC). Normally, a corporation is considered a legal entity separate from its shareholders or members, meaning that the personal assets of shareholders or members are protected from the liabilities of the corporation. However, there are certain situations where courts may decide to "pierce" or "lift" the corporate veil, holding shareholders or members personally liable for the debts or actions of the corporation.
Here are some common scenarios in which courts might lift the corporate veil:
Fraud or Illegality: If shareholders or members use the corporate structure to perpetrate fraud, evade legal obligations, or engage in illegal activities, courts may disregard the corporate entity and hold those individuals personally liable.
Undercapitalization: If a corporation is formed with insufficient capital to conduct its intended business and meet its foreseeable liabilities, and this lack of capitalization results in harm to creditors or other parties, courts may lift the corporate veil to hold shareholders or members liable.
Failure to Observe Corporate Formalities: Corporations and LLCs are required to observe certain formalities, such as holding regular meetings, maintaining separate financial records, and avoiding commingling of personal and corporate assets. If these formalities are not observed and the corporate structure is used as a mere façade, courts may disregard the corporate entity.
Alter Ego: If there is such a unity of interest and ownership between the corporation and its shareholders or members that the separate personalities of the corporation and the individuals no longer exist, courts may treat the corporation as the alter ego of its owners and hold them personally liable.
Group Enterprises: In some cases, where multiple corporations are closely related or form part of a single economic unit, courts may pierce the corporate veil to achieve equity, particularly if one corporation's actions harm creditors or other stakeholders and the corporate structure is being used to shield culpable parties from liability.
2024 State of Marketing Report – by HubspotMarius Sescu
https://www.hubspot.com/state-of-marketing
· Scaling relationships and proving ROI
· Social media is the place for search, sales, and service
· Authentic influencer partnerships fuel brand growth
· The strongest connections happen via call, click, chat, and camera.
· Time saved with AI leads to more creative work
· Seeking: A single source of truth
· TLDR; Get on social, try AI, and align your systems.
· More human marketing, powered by robots
ChatGPT is a revolutionary addition to the world since its introduction in 2022. A big shift in the sector of information gathering and processing happened because of this chatbot. What is the story of ChatGPT? How is the bot responding to prompts and generating contents? Swipe through these slides prepared by Expeed Software, a web development company regarding the development and technical intricacies of ChatGPT!
Product Design Trends in 2024 | Teenage EngineeringsPixeldarts
The realm of product design is a constantly changing environment where technology and style intersect. Every year introduces fresh challenges and exciting trends that mold the future of this captivating art form. In this piece, we delve into the significant trends set to influence the look and functionality of product design in the year 2024.
How Race, Age and Gender Shape Attitudes Towards Mental HealthThinkNow
Mental health has been in the news quite a bit lately. Dozens of U.S. states are currently suing Meta for contributing to the youth mental health crisis by inserting addictive features into their products, while the U.S. Surgeon General is touring the nation to bring awareness to the growing epidemic of loneliness and isolation. The country has endured periods of low national morale, such as in the 1970s when high inflation and the energy crisis worsened public sentiment following the Vietnam War. The current mood, however, feels different. Gallup recently reported that national mental health is at an all-time low, with few bright spots to lift spirits.
To better understand how Americans are feeling and their attitudes towards mental health in general, ThinkNow conducted a nationally representative quantitative survey of 1,500 respondents and found some interesting differences among ethnic, age and gender groups.
Technology
For example, 52% agree that technology and social media have a negative impact on mental health, but when broken out by race, 61% of Whites felt technology had a negative effect, and only 48% of Hispanics thought it did.
While technology has helped us keep in touch with friends and family in faraway places, it appears to have degraded our ability to connect in person. Staying connected online is a double-edged sword since the same news feed that brings us pictures of the grandkids and fluffy kittens also feeds us news about the wars in Israel and Ukraine, the dysfunction in Washington, the latest mass shooting and the climate crisis.
Hispanics may have a built-in defense against the isolation technology breeds, owing to their large, multigenerational households, strong social support systems, and tendency to use social media to stay connected with relatives abroad.
Age and Gender
When asked how individuals rate their mental health, men rate it higher than women by 11 percentage points, and Baby Boomers rank it highest at 83%, saying it’s good or excellent vs. 57% of Gen Z saying the same.
Gen Z spends the most amount of time on social media, so the notion that social media negatively affects mental health appears to be correlated. Unfortunately, Gen Z is also the generation that’s least comfortable discussing mental health concerns with healthcare professionals. Only 40% of them state they’re comfortable discussing their issues with a professional compared to 60% of Millennials and 65% of Boomers.
Race Affects Attitudes
As seen in previous research conducted by ThinkNow, Asian Americans lag other groups when it comes to awareness of mental health issues. Twenty-four percent of Asian Americans believe that having a mental health issue is a sign of weakness compared to the 16% average for all groups. Asians are also considerably less likely to be aware of mental health services in their communities (42% vs. 55%) and most likely to seek out information on social media (51% vs. 35%).
AI Trends in Creative Operations 2024 by Artwork Flow.pdfmarketingartwork
Creative operations teams expect increased AI use in 2024. Currently, over half of tasks are not AI-enabled, but this is expected to decrease in the coming year. ChatGPT is the most popular AI tool currently. Business leaders are more actively exploring AI benefits than individual contributors. Most respondents do not believe AI will impact workforce size in 2024. However, some inhibitions still exist around AI accuracy and lack of understanding. Creatives primarily want to use AI to save time on mundane tasks and boost productivity.
Organizational culture includes values, norms, systems, symbols, language, assumptions, beliefs, and habits that influence employee behaviors and how people interpret those behaviors. It is important because culture can help or hinder a company's success. Some key aspects of Netflix's culture that help it achieve results include hiring smartly so every position has stars, focusing on attitude over just aptitude, and having a strict policy against peacocks, whiners, and jerks.
PEPSICO Presentation to CAGNY Conference Feb 2024Neil Kimberley
PepsiCo provided a safe harbor statement noting that any forward-looking statements are based on currently available information and are subject to risks and uncertainties. It also provided information on non-GAAP measures and directing readers to its website for disclosure and reconciliation. The document then discussed PepsiCo's business overview, including that it is a global beverage and convenient food company with iconic brands, $91 billion in net revenue in 2023, and nearly $14 billion in core operating profit. It operates through a divisional structure with a focus on local consumers.
Content Methodology: A Best Practices Report (Webinar)contently
This document provides an overview of content methodology best practices. It defines content methodology as establishing objectives, KPIs, and a culture of continuous learning and iteration. An effective methodology focuses on connecting with audiences, creating optimal content, and optimizing processes. It also discusses why a methodology is needed due to the competitive landscape, proliferation of channels, and opportunities for improvement. Components of an effective methodology include defining objectives and KPIs, audience analysis, identifying opportunities, and evaluating resources. The document concludes with recommendations around creating a content plan, testing and optimizing content over 90 days.
How to Prepare For a Successful Job Search for 2024Albert Qian
The document provides guidance on preparing a job search for 2024. It discusses the state of the job market, focusing on growth in AI and healthcare but also continued layoffs. It recommends figuring out what you want to do by researching interests and skills, then conducting informational interviews. The job search should involve building a personal brand on LinkedIn, actively applying to jobs, tailoring resumes and interviews, maintaining job hunting as a habit, and continuing self-improvement. Once hired, the document advises setting new goals and keeping skills and networking active in case of future opportunities.
A report by thenetworkone and Kurio.
The contributing experts and agencies are (in an alphabetical order): Sylwia Rytel, Social Media Supervisor, 180heartbeats + JUNG v MATT (PL), Sharlene Jenner, Vice President - Director of Engagement Strategy, Abelson Taylor (USA), Alex Casanovas, Digital Director, Atrevia (ES), Dora Beilin, Senior Social Strategist, Barrett Hoffher (USA), Min Seo, Campaign Director, Brand New Agency (KR), Deshé M. Gully, Associate Strategist, Day One Agency (USA), Francesca Trevisan, Strategist, Different (IT), Trevor Crossman, CX and Digital Transformation Director; Olivia Hussey, Strategic Planner; Simi Srinarula, Social Media Manager, The Hallway (AUS), James Hebbert, Managing Director, Hylink (CN / UK), Mundy Álvarez, Planning Director; Pedro Rojas, Social Media Manager; Pancho González, CCO, Inbrax (CH), Oana Oprea, Head of Digital Planning, Jam Session Agency (RO), Amy Bottrill, Social Account Director, Launch (UK), Gaby Arriaga, Founder, Leonardo1452 (MX), Shantesh S Row, Creative Director, Liwa (UAE), Rajesh Mehta, Chief Strategy Officer; Dhruv Gaur, Digital Planning Lead; Leonie Mergulhao, Account Supervisor - Social Media & PR, Medulla (IN), Aurelija Plioplytė, Head of Digital & Social, Not Perfect (LI), Daiana Khaidargaliyeva, Account Manager, Osaka Labs (UK / USA), Stefanie Söhnchen, Vice President Digital, PIABO Communications (DE), Elisabeth Winiartati, Managing Consultant, Head of Global Integrated Communications; Lydia Aprina, Account Manager, Integrated Marketing and Communications; Nita Prabowo, Account Manager, Integrated Marketing and Communications; Okhi, Web Developer, PNTR Group (ID), Kei Obusan, Insights Director; Daffi Ranandi, Insights Manager, Radarr (SG), Gautam Reghunath, Co-founder & CEO, Talented (IN), Donagh Humphreys, Head of Social and Digital Innovation, THINKHOUSE (IRE), Sarah Yim, Strategy Director, Zulu Alpha Kilo (CA).
Trends In Paid Search: Navigating The Digital Landscape In 2024Search Engine Journal
The search marketing landscape is evolving rapidly with new technologies, and professionals, like you, rely on innovative paid search strategies to meet changing demands.
It’s important that you’re ready to implement new strategies in 2024.
Check this out and learn the top trends in paid search advertising that are expected to gain traction, so you can drive higher ROI more efficiently in 2024.
You’ll learn:
- The latest trends in AI and automation, and what this means for an evolving paid search ecosystem.
- New developments in privacy and data regulation.
- Emerging ad formats that are expected to make an impact next year.
Watch Sreekant Lanka from iQuanti and Irina Klein from OneMain Financial as they dive into the future of paid search and explore the trends, strategies, and technologies that will shape the search marketing landscape.
If you’re looking to assess your paid search strategy and design an industry-aligned plan for 2024, then this webinar is for you.
5 Public speaking tips from TED - Visualized summarySpeakerHub
From their humble beginnings in 1984, TED has grown into the world’s most powerful amplifier for speakers and thought-leaders to share their ideas. They have over 2,400 filmed talks (not including the 30,000+ TEDx videos) freely available online, and have hosted over 17,500 events around the world.
With over one billion views in a year, it’s no wonder that so many speakers are looking to TED for ideas on how to share their message more effectively.
The article “5 Public-Speaking Tips TED Gives Its Speakers”, by Carmine Gallo for Forbes, gives speakers five practical ways to connect with their audience, and effectively share their ideas on stage.
Whether you are gearing up to get on a TED stage yourself, or just want to master the skills that so many of their speakers possess, these tips and quotes from Chris Anderson, the TED Talks Curator, will encourage you to make the most impactful impression on your audience.
See the full article and more summaries like this on SpeakerHub here: https://speakerhub.com/blog/5-presentation-tips-ted-gives-its-speakers
See the original article on Forbes here:
http://www.forbes.com/forbes/welcome/?toURL=http://www.forbes.com/sites/carminegallo/2016/05/06/5-public-speaking-tips-ted-gives-its-speakers/&refURL=&referrer=#5c07a8221d9b
ChatGPT and the Future of Work - Clark Boyd Clark Boyd
Everyone is in agreement that ChatGPT (and other generative AI tools) will shape the future of work. Yet there is little consensus on exactly how, when, and to what extent this technology will change our world.
Businesses that extract maximum value from ChatGPT will use it as a collaborative tool for everything from brainstorming to technical maintenance.
For individuals, now is the time to pinpoint the skills the future professional will need to thrive in the AI age.
Check out this presentation to understand what ChatGPT is, how it will shape the future of work, and how you can prepare to take advantage.
The document provides career advice for getting into the tech field, including:
- Doing projects and internships in college to build a portfolio.
- Learning about different roles and technologies through industry research.
- Contributing to open source projects to build experience and network.
- Developing a personal brand through a website and social media presence.
- Networking through events, communities, and finding a mentor.
- Practicing interviews through mock interviews and whiteboarding coding questions.
Google's Just Not That Into You: Understanding Core Updates & Search IntentLily Ray
1. Core updates from Google periodically change how its algorithms assess and rank websites and pages. This can impact rankings through shifts in user intent, site quality issues being caught up to, world events influencing queries, and overhauls to search like the E-A-T framework.
2. There are many possible user intents beyond just transactional, navigational and informational. Identifying intent shifts is important during core updates. Sites may need to optimize for new intents through different content types and sections.
3. Responding effectively to core updates requires analyzing "before and after" data to understand changes, identifying new intents or page types, and ensuring content matches appropriate intents across video, images, knowledge graphs and more.
A brief introduction to DataScience with explaining of the concepts, algorithms, machine learning, supervised and unsupervised learning, clustering, statistics, data preprocessing, real-world applications etc.
It's part of a Data Science Corner Campaign where I will be discussing the fundamentals of DataScience, AIML, Statistics etc.
Time Management & Productivity - Best PracticesVit Horky
Here's my presentation on by proven best practices how to manage your work time effectively and how to improve your productivity. It includes practical tips and how to use tools such as Slack, Google Apps, Hubspot, Google Calendar, Gmail and others.
The six step guide to practical project managementMindGenius
The six step guide to practical project management
If you think managing projects is too difficult, think again.
We’ve stripped back project management processes to the
basics – to make it quicker and easier, without sacrificing
the vital ingredients for success.
“If you’re looking for some real-world guidance, then The Six Step Guide to Practical Project Management will help.”
Dr Andrew Makar, Tactical Project Management
Beginners Guide to TikTok for Search - Rachel Pearson - We are Tilt __ Bright...
Recro vs Actavis Case 1:14-cv-01118-GMS Appendix of Trial Evidence
1. IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
RECRO GAINESVILLE LLC,
Plaintiff,
v.
ACTAVIS LABORATORIES FL, INC.,
Defendant.
)
)
)
)
)
)
)
)
)
C.A. No. 14-1118 (GMS)
CONSOLIDATED
JOINT APPENDIX OF TRIAL EVIDENCE
MORRIS, NICHOLS, ARSHT & TUNNELL LLP
Jack B. Blumenfeld (#1014)
Maryellen Noreika (#3208)
Jeremy A. Tigan (#5239)
Megan E. Dellinger (#5739)
1201 North Market Street
P.O. Box 1347
Wilmington, DE 19899-1347
(302) 658-9200
jblumenfeld@mnat.com
mnoreika@mnat.com
jtigan@mnat.com
mdellinger@mnat.com
Attorneys for Recro Gainesville LLC
RICHARDS, LAYTON & FINGER, P.A.
Kelly E. Farnan (#4395)
920 N. King Street
Wilmington, DE 19801
(302) 651-7700
farnan@rlf.com
OF COUNSEL:
B. Jefferson Boggs
MERCHANT & GOULD, P.C.
1701 Duke Street, Suite 310
Alexandria, VA 22314
Christopher J. Sorenson
Rachel C. Hughey
Aaron M. Johnson
Andrew O. Larsen
MERCHANT & GOULD, P.C.
3200 IDS Center
80 S. Eighth Street
Minneapolis, MN 55402
Thomas J. Meloro
Heather M. Schneider
WILLKIE FARR & GALLAGHER LLP
787 Seventh Avenue
New York, NY 10019
Attorneys for Actavis Laboratories FL, Inc.
November 7, 2016
Case 1:14-cv-01118-GMS Document 124 Filed 11/07/16 Page 1 of 9 PageID #: 1834
2. - 1 -
JOINT APPENDIX OF TRIAL EVIDENCE
EXHIBIT
NO.
DATE BATES NOS. DESCRIPTION ADMITTED
JTX 002 06/07/05 U.S. Patent No. 6,902,742 (Devane et al.) Siepmann Direct; Siepmann Cross;
Fleckenstein Direct; Fleckenstein
Cross; Felton Direct; Felton Cross;
Dowling Direct; Dowling Cross
JTX 003 09/15/15 U.S. Patent No. 9,132,096 (Rekhi et al.) Siepmann Direct; Siepmann Cross;
Felton Direct
JTX 010 05/01/02 ACT-HYD-0100899–
ACT-HYD-0101008;
FLECK_ALV 0000001–
FLECK_ALV 0000110
Center for Drug Evaluation and
Research, Appl. No. 202880Orig1s000,
Clinical Pharmacology and
Biopharmaceutics Review(s)
Fleckenstein Direct
JTX 021 00/00/11 FLECK_ALV 0000194–
FLECK_AVL 0000259;
FLECK_ACT 0000090–
FLECK_ACT 0000155
Tozer et al., Clinical Pharmacokinetics &
Pharmacodynamics: Concepts &
Applications, Chapters 2 and 7
(Lippincott Williams & Wilkins (4th ed.,
2011))
Fleckenstein Direct
JTX 022 01/00/16 FLECK_ALV 0000260–
FLECK_ALV 0000285
Zohydro® ER Package Insert Fleckenstein Direct
JTX 030
[SEALED]
02/26/14 ACT-HYD-0001362–
ACT-HYD-0001455
Hydrocodone Bitartrate Extended
Release Capsules 10, 15, 20, 30, 40 &
50 mg (ANDA# 206952) Product
Development Report
Siepmann Direct; Fleckenstein
Cross; Fleckenstein Direct;
Felton Cross
JTX 031 02/26/14 ACT-HYD-0004344–
ACT-HYD-0004892
Hydrocodone Bitartrate ER Capsules
10 mg (Fasted Study) - Bioequivalence
Study Report for ACT-12719
Fleckenstein Direct;
Dowling Direct
Case 1:14-cv-01118-GMS Document 124 Filed 11/07/16 Page 2 of 9 PageID #: 1835
3. - 2 -
EXHIBIT
NO.
DATE BATES NOS. DESCRIPTION ADMITTED
JTX 032 02/26/14 ACT-HYD-0007314–
ACT-HYD-0007866
Hydrocodone Bitartrate ER Capsules
10 mg (Fed Study) - Bioequivalence
Study Report for ACT-12720
Fleckenstein Direct;
Dowling Direct
JTX 033 03/07/15 ACT-HYD-0018551–
ACT-HYD-0018852
Analytical Report - An Open Labeled,
Randomized, Single Dose, Two Way
Crossover Bioequivalence Study of
Hydrocodone Bitartrate Extended
Release Capsules, 10 mg, CII in Healthy,
Adult, Human, Subjects Under Fasting
Conditions (Protocol # ACT-15030)
ANDA Sequence 0006
Fleckenstein Re-Direct
JTX 034 03/26/15 ACT-HYD-0015667–
ACT-HYD-0015728
An Open-Label, Randomized, Single
Dose, Two Way Crossover
Bioequivalence Study of Hydrocodone
Bitartrate Extended Release Capsules,
10 mg, CII in Healthy, Adult, Human
Subjects Under Fasting Conditions
(Study # ACT-15030) ANDA Sequence
0006
Dowling Direct
JTX 035
[SEALED]
04/06/15 ACT-HYD-0012415–
ACT-HYD-0012479
Hydrocodone Bitartrate Extended
Release Capsules 10, 15, 20, 30, 40 &
50 mg (ANDA# 206952) Addendum to
Product Development Report ANDA
Sequence 0006
Siepmann Direct; Fleckenstein
Cross; Felton Cross
JTX 041 ACT-HYD-0015617–
ACT-HYD-0015630
Hydrocodone Bitartrate ER Capsules,
10 mg CII (Fasting Study), pages from
Study ACT-15030, plasma
concentrations
Fleckenstein Direct;
Dowling Direct
Case 1:14-cv-01118-GMS Document 124 Filed 11/07/16 Page 3 of 9 PageID #: 1836
4. - 3 -
EXHIBIT
NO.
DATE BATES NOS. DESCRIPTION ADMITTED
JTX 042 ACT-HYD-0035905–
ACT-HYD-0035907
Actavis testing documents, ER Capsules
USP Method
Fleckenstein Direct
JTX 043 ACT-HYD-0036111–
ACT-HYD-0036117
Actavis testing documents, ER Capsules
USP Method
Fleckenstein Direct
JTX 044
[SEALED]
ACT-HYD-0085245–
ACT-HYD-0085339
Actavis Laboratories FL, Inc. ANDA #
206952 Sequence # 0012
2.3 Quality Overall Summary
Siepmann Direct;
Fleckenstein Direct
Felton Direct
JTX 045
[SEALED]
ACT-HYD-0085660–
ACT-HYD-0085870
Actavis Laboratories FL, Inc. ANDA #
206952 Sequence # 0012
2.7 Clinical Summary (Hydrocodone
Extended-Release Capsules)
Fleckenstein Direct
JTX 098 04/11/12 DARA_Z0132703–
DARA_Z0132810
Formulation Report for Hydrocodone
Bitartrate Extended-Release (ER)
Capsules Comprehensive Pharmaceutical
Development Report [10, 15, 20, 30, 40
and 50 mg] (RD-2012-FOR-003)
Sidwell Designations
JTX 105 DARA_Z0093624–
DARA_Z0093676
Zogenix Hydrocodone Bitartrate ER
NDA Module 2.5 Clinical Overview
Rekhi Designations
JTX 107 Curriculum Vitae of Dr. Thomas
Dowling
Dowling Direct
JTX 108 Curriculum Vitae of Linda Felton, Ph.D. Felton Direct
JTX 109 Curriculum Vitae of Lawrence L.
Fleckenstein, Pharm.D.
Fleckenstein Direct
Case 1:14-cv-01118-GMS Document 124 Filed 11/07/16 Page 4 of 9 PageID #: 1837
5. - 4 -
EXHIBIT
NO.
DATE BATES NOS. DESCRIPTION ADMITTED
JTX 112 Curriculum Vitae of Prof. Dr. Jürgen
Siepmann
Siepmann Direct
PTX 030 00/00/01 SIE_ACT 0000213–
SIE_ACT 0000296
Edgar et al., Advances in Cellulose Ester
Performance and Application, Progress
Polymer Sci., 26:1605–88 (2001)
Siepmann Direct
PTX 038 00/00/01 SIE_ACT 0000504–
SIE_ACT 0000504
Heinze et al., Unconventional Methods in
Cellulose Functionalization, Progress
Polymer Sci., 26:1689–1762 (2001)
Siepmann Direct
PTX 048 00/00/10 SIE_ACT 0000073–
SIE_ACT 0000085
Mandal et al., Drug Delivery System
Based on Chronobiology – A Review, J.
Controlled Release, 147:314–25 (2010)
Siepmann Direct
PTX 051 00/00/06 SIE_ACT 0000111–
SIE_ACT 0000117
Mohamad et al., pH-independent
Pulsatile Drug Delivery System Based on
Hard Gelatin Capsules and Coated with
Aqueous Dispersion Aquacoat ECD,
European Journal of Pharmaceutics and
Biopharmaceutics, 64:173–79 (2006)
Siepmann Direct
PTX 056 12/00/11 SIE_ACT 0000126–
SIE_ACT 0000141
Patil et al., Development and
Characterization of Chronomodulated
Drug Delivery System of Captopril, Int. J.
Pharma. Investig., 1(4):227–33 (Oct.–
Dec. 2011)
Felton Cross
Case 1:14-cv-01118-GMS Document 124 Filed 11/07/16 Page 5 of 9 PageID #: 1838
6. - 5 -
EXHIBIT
NO.
DATE BATES NOS. DESCRIPTION ADMITTED
PTX 060 00/00/00 SIE_ACT 0000202–
SIE_ACT 0000212
Porter, Coating of Pharmaceutical
Dosage Forms in Remington: The
Science and Practice of Pharmacy,
Chapter 46 (Alfonso R. Gennaro ed.,
20th ed. 2000)
Siepmann Direct
PTX 064 00/00/01 SIE_ACT 0000616–
SIE_ACT 0000634
Siepmann et al., Modeling of Drug
Release from Delivery Systems Based on
Hydroxypropyl Methylcellulose (HPMC),
Advanced Drug Delivery Revs. 48:139–
157 (2001)
Siepmann Direct
PTX 065 00/00/08 SIE_ACT 0000635–
SIE_ACT 0000649
Siepmann et al., Polymer Blends for
Controlled Release Coatings, J.
Controlled Release 125:1–15 (2008)
Siepmann Direct
PTX 068 00/00/04 SIE_ACT 0000170–
SIE_ACT 0000182
Sungthongjeen et al., Development of
Pulsatile Release Tablets with Swelling
and Rupturable Layers, Journal of
Controlled Release, 95:147–59 (2004)
Siepmann Direct;
Felton Cross
PTX 072 00/00/11 SIE_ACT 0000183–
SIE_ACT 0000192
Yadav et al., Dual Coating of Swellable
and Rupturable Polymers on Glipizide
Loaded MCC Pellets for Pulsatile
Delivery: Formulation Design and in
vitro Evaluation, Int’l. J. of Pharma.
419:121–30 (2011)
Siepmann Direct
Case 1:14-cv-01118-GMS Document 124 Filed 11/07/16 Page 6 of 9 PageID #: 1839
7. - 6 -
EXHIBIT
NO.
DATE BATES NOS. DESCRIPTION ADMITTED
PTX 074 00/00/98 FLECK_ACT 0000156–
FLECK_ACT 0000164
Yuan et al., The Safety and Efficacy of
Oral Methylnaltrexone in Preventing
Morphine-Induced Delay in Oral-Cecal
Transit Time, Clin. Pharmacology &
Therapeutics, 61(4):467–75 (Apr. 1997)
Fleckenstein Direct
PTX 126 12/02/14 ACT-HYD-0028659–
ACT-HYD-0028660
Email from M. Udan to S. Mukherjee re:
Pilot Bio Shipping for Hydrocodone
Bitartrate ER Capsules (Zohydro Abuse
Deterrent)
Fleckenstein Direct
PTX 131 02/18/15 ACT-HYD-0020966–
ACT-HYD-0021039
Clinical Study Protocol - An Open
Labeled, Randomized, Single Dose, Two
Way Crossover Bioequivalence Study of
Hydrocodone Bitartrate Extended
Release Capsules, 10 mg, CII in Healthy,
Adult, Human, Subjects Under Fasting
Conditions (Protocol # ACT-15030)
Fleckenstein Direct
PTX 175 ACT-HYD-0085235–
ACT-HYD-0085238
Actavis Laboratories FL, Inc.
ANDA # 206952 Sequence # 0012
1.12.15 Request for In Vivo
Bioequivalence Waiver
Fleckenstein Direct
DTX 512 5/8/2000 ACT-HYD-0100535–
ACT-HYD-0100542
Serial 09/566,636 - Response Felton Direct
DTX 513 12/05/00 ACT-HYD-0100543–
ACT-HYD-0100546
Serial 09/566,636 - Notice of
Allowability
Felton Direct
DTX 519 Serial 10/827,689 Reply Felton Direct; Felton Cross
Case 1:14-cv-01118-GMS Document 124 Filed 11/07/16 Page 7 of 9 PageID #: 1840
8. - 7 -
EXHIBIT
NO.
DATE BATES NOS. DESCRIPTION ADMITTED
DTX 550 12/29/15 Order Construing Terms of ‘398 and ‘742
Patents, D.I. 69
Felton Direct;
Dowling Direct
DTX 559 08/29/99 ACT-HYD-0107820–
ACT-HYD-0107832
US Patent 5,445,829 to Paradissis Felton Direct
DTX 568 12/25/12 ACT-HYD-0105521–
ACT-HYD-0105544
US Patent 8,337,888 Wright Felton Cross
DTX 572 10/26/06 ACT-HYD-0105163–
ACT-HYD-0105189
US Application Publication No.
2006/0240105 Devane
Fleckenstein Cross;
Rekhi Designation
DTX 579 06/19/91 ACT-HYD-0107868–
ACT-HYD-0107891
EP Patent Specification 0 274 734 B1 La
Manna
Felton Cross
DTX 592 11/00/87 DARA_Z0205565 Baumann, “Analgesic Safety and Efficacy
of Controlled Release Hydrocodone”,
Journal of Pharmaceutical Sciences S107,
76(11) Poster E 03-X-02 (November
1987)
Rekhi Designations
DTX 602 00/00/91 DARA_Z0068181–
DARA_Z0068186
Giunchedi et al., “Ketoprofen pulsatile
absorption from ‘multiple unit’
hydrophilic matrices,” Int’l J. of
Pharmaceutics, 77:17–181 (1991)
Dowling Direct
DTX 616 00/00/08 McGinity, Felton, “Aqueous Polymeric
Coatings for Pharmaceutical Dosage
Forms”, 3rd Ed., Chapter 8, pp. 203–235;
(2008)
Siepmann Cross
Case 1:14-cv-01118-GMS Document 124 Filed 11/07/16 Page 8 of 9 PageID #: 1841
9. - 8 -
EXHIBIT
NO.
DATE BATES NOS. DESCRIPTION ADMITTED
DTX 650 DARA_Z0067790–
DARA_Z0067813
Elan Technology Focus, Helping You
Bring Products to Market, presentation
Sidwell Designations
DTX 651 05/05/15 DARA_Z0223416–
DARA_Z0223449
Recro Gainesville, Recro Pharma-Pernix
Therapeutics Face to Face Meeting
PowerPoint presentation
Sidwell Designations
DTX 653 10/23/12 DARA_Z0240054–
DARA_Z0240114
Zogenix Pre-IND 115,964 Meeting
Briefing Document, ER capsules/abuse
deterrent
Sidwell Designations
DTX 661 Gurvinder Singh Rekhi CV Rekhi Designations
DTX 662 10/00/00 DARA_Z0198082–
DARA_Z0198091
Elan Pharmaceutical Technologies’
Proposal to Elan Pharmaceuticals to
develop a once daily controlled release
formulation of hydrocodone
Rekhi Designations
DTX 666 03/26/01 DARA_Z0210719–
DARA_Z0210743
Elan Ireland Memo from Tembe to Butler
re hydrocodone simulations
Rekhi Designations
DTX 668 06/25/02 DARA_Z0203216–
DARA_Z0203356
Elan letter to FDA submitting IND
application for hydrocodone ER capsules
(ELN 154088) (attached)
Rekhi Designations
DTX 672 10/25/13 NDA 202880rig1s000 Summary Review,
Zohydro ER
Rekhi Designations
DTX 812 4/9/1998 DARA_Z0046769–
DARA_Z0046810
WO 98/14168 - Alza Corp. Application
for International Patent
Fleckenstein Cross
10528465
Case 1:14-cv-01118-GMS Document 124 Filed 11/07/16 Page 9 of 9 PageID #: 1842