1. Introduction

1.1  Redica Systems, Inc., a Delaware corporation, (“Redica”, “Us”, or “We”) operates redica.com as well as websites contained within or otherwise available through external hyperlinks within redica.com, certain mobile versions and apps of the foregoing, and associated social media outlets (collectively, the “Site”). Within the Site, We provide access to publicly available information from governmental agencies, analyses and data analytics conducted by Us and our partners, and user discussion/chat rooms containing user-provided Content, as defined below, as well as content We provide (collectively, the “Services”).

1.2 By using the Services, you, as either an individual or, as a representative of a company or business entity if You are using a company or business entity email as your contact information, (“You”) agree to all of these terms and conditions which are a legally binding contract between You and Us, including our Privacy Policy (covering how we collect, use, share, track and store your personal information and Your use of the Services and the Site)  (collectively, the “Agreement”). If you purchase Services from us, you also agree to any terms or conditions contained in an order form detailing the Services you have purchased, which shall become part of this Agreement (an “Order Form”). In the event of a conflict between these terms and conditions, our Privacy Policy or an Order Form, the following order of precedence shall govern: (1) Order Form, (2) Privacy Policy, (3) these terms and conditions.  In the event that you do not agree to this Agreement, then do not access, purchase, or otherwise use any of the Services. We and You are the only parties to this Agreement and there are no third-party beneficiaries to the Agreement.

2. The Services

2.1 Permitted Use. You may use the Services during the term of this Agreement solely for Your internal business purposes that are supported by the Content or material to which they relate; provided that, if You are using the Services in your role as an employee of an academic institution, You may use the Services for your academic research purposes.

2.2 Limitations. You agree to the following limitations and obligations in Your use of the Services:

(i) You are legally permitted to enter this Agreement and that, if using the Services on behalf of a business entity, you are authorized to bind such entity contractually to the terms of this Agreement.

(ii) You will comply with all applicable laws, including, without limitation, privacy laws, intellectual property laws, anti-spam laws, export control laws, tax laws, and regulatory requirements;

(iii) You will, when posting Content, ensure that i) all Content is relevant to the discussion or topic to which you are contributing, ii) all Content is both accurate and not misleading, and iii) that you have the necessary intellectual property rights to provide the Content and to grant the license to such Content as described in Section 4.

(iv) You will keep your contact information up to date within the Site and you will maintain the security and confidentiality of any username and password you use within the Site, for the avoidance of doubt, this prohibits you from sharing your username or password with any other person or entity;

(v) You will neither use the Services to compete with us nor will You use them for any purpose other than those permitted under Section 2.1; for the avoidance of doubt, this prohibits Your use of the Services for building a library of the documents provided to You via the Services;

(vi) You will not use the Services manually or in an automated fashion, to excessively download any material or Content available through the Services, as determined in our sole discretion, nor will You develop, support, or use software, devices, scripts, robots, or any other means or processes (including crawlers, browser plugins, and add-ons, or any other technology) to scrape the Services or otherwise copy data or Content from the Services;

(vii) You will not reverse engineer, decompile, disassemble, decipher or otherwise attempt to derive the source code for the Services or any related technology;

(viii) You will not post or upload Content that is harassing, defamatory, abusive, threatening, obscene, harmful, tortuous, libelous, or invasive of another’s privacy or includes any unauthorized advertising, promotional materials, chain letters, spam, junk mail, or any other type of unsolicited mass e-mail to people or entities that have not agreed to be part of such mailings;

(ix) You will not upload or post Content that contains any digital worms, viruses, or other harmful, disruptive, or destructive files, code, or programs;

2.3 Changes to the Service. We may change, suspend or end the Services or any portion of them, or change and modify prices prospectively at our discretion by indicating such changes on the Site which constitutes notice to You. Such changes shall become effective upon your use of the Services following our notice to you, as indicated above.

3. Term, Termination and Suspension.

3.1 Term. This Agreement will remain in effect for the longer of i) so long as you make use of the Services; or ii) for so long as an Order Form remains in effect. Order Forms shall continue for the time period stated within them and shall auto-renew for 12 months periods unless either party provides 30 days advance written notice of its intent to not renew the Order Form.

3.2 Termination. You may terminate this Agreement by ceasing all use of the Services or, if you have entered an Order Form, by notifying us in writing of your desire to terminate the Agreement. In the event you terminate an Order Form prior to its expiration date, you will not receive a refund on the prorated amount of your payment for the period of Service not provided. We may terminate this Agreement i) by ceasing to provide the Services and, in the event that You have paid for any Services, we will refund a prorated amount of your payment for the period of Service not provided, or ii) if You have breached any term of this Agreement and failed to cure such breach within 5 days of our notice to You sent to the contact information you have provided in the Site. Sections 4, 6, 7, 8, and 9 will survive the termination of this Agreement.

3.3 Suspension. We may suspend Your use of the Service, in our sole discretion, if we believe that i) You have violated any of the terms of this Agreement, or ii) Your user credentials have been compromised.

4. Intellectual property

4.1 Content. “Content” means all content, including any text, images, photos, audio, video, and all other forms of data or communication that You or another user posts or otherwise provides or submits to Us via the Site, but excluding personally identifiable information such as Your name or email address. As between You and Us, all Content shared by You is owned by You and you are solely responsible such Content.

4.2 License to Content. By providing Content you hereby grant Us a perpetual, irrevocable, non-exclusive, transferable, royalty-free, fully sublicensable, fully paid-up, worldwide license and right to use, modify, copy, reproduce, publish, distribute, publicly perform or display, adapt, translate, create derivative works, archive, store, upload, share, post, sublicense, or otherwise make available Your Content in any form and through any media of any kind now known or later developed, for any purpose, with or without attribution.

4.3 Our Intellectual Property. We reserve all of our intellectual property rights in the Services and the Site. Using the Services does not give you any ownership in our Services or the content or information made available through our Services or the Site. Trademarks and logos used in connection with the Services are the trademarks of their respective owners. Redica Systems, Redica, FDAzilla, Govzilla, other “zilla” logos, and other Redica Systems trademarks, service marks, graphics, and logos used for our Services are trademarks or registered trademarks of Ours. You may not use or display any trademarks, service marks, logos, or designs owned by Us without our prior written consent.

5. Payment

5.1 As consideration for the Services, You will pay any fees specified within an Order no later than 30 days after You have received our invoice. Past due balances will accrue interest per month at 1.5% or at the maximum applicable statutory rate, whichever is lower. You are responsible for any tax, tariff, customs duty, surcharge, or other fee imposed by law or regulation in connection with the Services.

6. Limitation of Liability

6.1 Disclaimer. AS PART OF THE CONSIDERATION FOR THE SERVICES PROVIDED UNDER THIS AGREEMENT AND, EXCEPT AS PROHIBITED BY LAW WE ARE NOT LIABLE (WHETHER IN CONTRACT, TORT OR UNDER ANY OTHER FORM OF LIABILITY AND IRRESPECTIVE OF WHETHER YOU OR SOMEONE ELSE HAS INFORMED US OF THE POSSIBILITY OF SUCH LIABILITY) TO YOU OR OTHERS FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL OR PUNITIVE DAMAGES, OR ANY INACCURATE DATA, INFORMATION OR CONTENT, LOSS OF DATA, CONTENT, INFORMATION, PROFITS OR REVENUES, RELATED TO THE SERVICES.

6.2 Limitation. IN NO EVENT SHALL OUR LIABILITY EXCEED, IN THE AGGREGATE FOR ALL CLAIMS, AN AMOUNT THAT IS THE LESSER OF (A) THE FEES FOR THE MOST RECENT 12 MONTH PERIOD THAT YOU PAID FOR THE SERVICES, IF ANY, OR (B) USD $1,000.

6.3 Materiality and Survival. THIS LIMITATION OF LIABILITY IS A MATERIAL INDUCEMENT FOR US TO ENTER INTO THIS AGREEMENT AND IS INTENDED TO SURVIVE A FINDING BY A COURT OR ARBITER THAT THE EXCLUSIVE REMEDIES UNDER THIS AGREEMENT FAIL OF THEIR ESSENTIAL PURPOSE.

7. Warranty Disclaimer

7.1 EXCEPT FOR ANY WARRANTIES THAT CANNOT BE EXCLUDED BY LAW, THE SERVICES (INCLUDING CONTENT AND INFORMATION) ARE PROVIDED SOLELY ON AN “AS IS” AND “AS AVAILABLE” BASIS AND WE DO NOT GUARANTEE THAT THE SERVICES WILL BE UNINTERRUPTED OR THAT THEY ARE ERROR-FREE. WE DISCLAIM ALL EXPRESS, IMPLIED, OR STATUTORY WARRANTIES AND REPRESENTATIONS INCLUDING THE WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, ACCURACY OF DATA, AND NONINFRINGEMENT.

8. Indemnification

8.1 You agree to defend, indemnify, and hold Us and Our affiliates, directors, officers, employees, and agents harmless from and against any demands, loss, liability, claims, damages, or expenses (including reasonable attorneys’ fees and costs), made against us by any third party due to, arising out of, or related to (i) Your use of the Services, (ii) any Content You use or distribute outside of the Site, or, within the Site, post, upload, or transmit, and (iii) Your breach of this Agreement.

9. General

9.1 Change. We may make changes to this Agreement from time to time at our sole discretion by updating by posting the updated Agreement to the Site and specifying the effective date of the new version of the Agreement. Your continued use of the Services following the posting of a new version of the Agreement constitutes your acceptance of any such changes. Accordingly, whenever you visit the Site, you should check to see if a new version of the Agreement has been posted.

9.2 Assignment. You may not assign this Agreement without our prior written consent. You agree that we may assign this Agreement, without your consent, to any affiliate of ours or to anyone who purchases Us, substantially all of our assets, or the Services that you use.

9.3 Severability. If any provision of this Agreement is found by a court of competent jurisdiction to be contrary to law, the provision shall be modified by the court and interpreted so as to best accomplish the objectives of the original provision to the fullest extent permitted by law, and the remaining provisions of the Agreement shall remain in effect.

9.4 Governing Law, Jurisdiction, Trial. This Agreement and the resolution of any dispute related to this Agreement or the Services is governed by and construed in accordance with the laws of Delaware without giving effect to any principles of conflicts of law. Any legal action or proceeding between Us and You related to the Agreement will be brought exclusively in a federal or state court of competent jurisdiction sitting in the state of Delaware, United States, and You and We agree to submit to the personal and exclusive jurisdiction of such courts. We and You waive any right to a jury trial in connection with any action arising out of or related to this Agreement.

9.5 Waiver. Neither We nor You waive our respective rights to enforce a breach of this Agreement by virtue of having failed to enforce or having waived a previous breach of this Agreement.

9.6 Subcontractors. We have the right to use subcontractors, without notice to you or consent from you, to perform any part of the Services or fulfill our other obligations under the Agreement.

9.7 Attorney’s Fees. In any action to enforce this Agreement, the prevailing party shall be entitled to attorneys’ fees and costs, in addition to such other damages as may be awarded.

9.8 Notice. You agree that We will provide notices and messages to you either using the Services or to the contact information you provided us through your use of the Services; consequently, You agree to keep Your contact information up to date. You agree to provide us legal notices at the following address:

Redia Systems, Inc.

Attention: Contracts Administrator

6800 Koll Center Parkway

Suite 120

Pleasanton, CA 94566

Effective Date:  April 2, 2020, Version 3.3

Human Factors – Compliance and Applications

June webinar

Presented by Alison Sathe, Founder, Regulatory Mark & Valerie Fenster, Director of Insights and  Human Factors, Kaleidoscope Innovation 

June 29, 1:30 p.m. EST

What you will learn:

  • Human factors strategies from simple drug products to complex surgical devices
  • Primary and secondary labeling development and evaluation for usability
  • Human factors activities from product development to post-market
  • International strategies: expectations for human factors in regulatory submissions in international markets

Panel Discussion – Remote Audits

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Featuring Panelists:
—Barbara W. Unger, Unger Consulting, Inc.
—Jerry Chapman, Redica Systems
—Stephanie Gaulding, Pharmatech Associates

Who Will Benefit?
This session will be valuable to GMP quality, regulatory, compliance, and management personnel in FDA-regulated industries who want to have a conversation on remote audits and get to know what is going on in the industry.

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Download your copy of THE FDA INSPECTION LANDSCAPE IN MID-2020 AND A LOOK AT VIRTUAL INSPECTION

In this summary we identify:

  • Trend analysis of FDA inspections through mid-2020
  • Strategies for preparing and hosting virtual inspections
  • New technologies to support remote inspections

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In this summary we identify:

FY2018-FY2020 GMP data for Lonza & Catalent

Top GMP primary citations

Top FDA 483 observations

Turning Failure into Success

Presented on Tuesday, April 27, 2021 by Steve Greer, Executive Coach, Genesis Assist, and former Quality Leader, Procter and Gamble

What you will learn:

  • How to use the Leadership SOS Model to transform quality culture
  • How to strengthen quality systems to eliminate human error
  • How to generate ideas on how to set your organization up for success for shareholders, FDA, and staff
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Quality Management Systems for Small Pharma and Biotech Firms

Webinar: QMS for Small Pharma and Biotech Firms

Presented by Fenton Fong, Founder, Managing Director, & Principal at xCellarate

Get instant access to the webinar video and slides.

What you will learn:

  • Common challenges small pharma firms face when developing a QMS
    Recent enforcement trends involving the Quality Unit
    Impact of the COVID-19 pandemic

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In this summary we identify:

GMP data from FY2017 to FY2020 for the Asia-Pacific region

Top 3 GMP primary and secondary citations

Top 3 483 observations

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An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report

In this summary we identify:

  • Data from 2019 UK MHRA Inspections
  • Trends from 2015, 2016, 2018, and 2019 inspections
  • Conclusions drawn from an analysis of drug inspection data

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INDEX INFORMATION  Redica consolidates regulatory data in real-time on the single largest database for quality, safety, and compliance intelligence.

STRENGTHEN DATASETS Redica machine intelligence algorithms identify and triage risk signals to derive meaning from vast amounts of private and public data.

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