Health Authority Decisions
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Watch to see how to search, make notes, compare health authority approvals and
save information in your personal library for reference.
A&P Enforcement Documentation
Free Search Solution!
Watch to see how to search A&P Enforcement Documentation, make notes, and save information in your personal library for reference.
Preview of what is Coming Soon to MyIndago Search!
FDA Advisory Committee Materials and Global Health Authority Approval Documents from different jurisdictions around the globe.
About Us
Developed by OneSource Regulatory (OSR), is a solution called MyIndago. Our first product, called MyIndago Advertising and Promotion (A&P), is a solution that allows a user to search pharmaceutical and biotech U.S. Food & Drug Administration correspondence regarding advertising and promotion regulation. Our second solution, called MyIndago Health Authority Decisions (HAD), is a separate solution that allows users to easily search and compare FDA and EMA approval documents for thousands of approved drugs. Advanced Filter options with the FDA search enables the user to find additional categories such as Off-Patent, Off-Exclusivity Drugs without an Approved Generic and REMS products.
OneSource Regulatory (OSR) is the first full-service provider in our industry to offer innovative software and solutions for Regulatory, Medical and Compliance professionals. Utilizing expertise from decades of proven industry experience, OneSource provides the following unparalleled services:
-
Regulatory Affairs
- Advertising & Promotion Review
- Labeling development (TPP, CCDS, and local label development, including the US PI and the EU SPC)
- Chemistry, Manufacturing & Controls (CMC)
- Strategy (NDA, MAA preparation; Health Authority liaison)
- Medical Affairs
-
Advertising and Promotion Review
- Review of Independent scientific exchange materials, grant requests, and independent research study proposals
-
Commercial Compliance
- Monitoring
- Policy development
- Compliance Support
-
Software Solutions
- MyIndago A&P (Advertising and Promotion) and Health Authority Decisions (HAD)
- NEW! DOC™Label* licenses and subscriptions, an exclusive partnership with Doctor Evidence
Click here to contact OneSource Regulatory and learn more about our affordable and flexible services and software solutions. Or call us at +1 (833) OSR-TEAM.
Click here to watch the MyIndago Introduction Video.
- Click to access a short video about a specific topic:
*OneSource Regulatory has partnered with Doctor Evidence, and now offers the DOC™ Label solution to pharmaceutical and biotech companies outside the Top 30 companies. DOC™Label is a centralized repository for structured and unstructured data contained in package inserts, including US and UK labels, allowing users to directly compare indications across labels. OneSource Regulatory offers licenses and subscription services through our exclusive partnership with Doctor Evidence.
OSR knows MLR
Looking for the best Medical, Regulatory and Legal Reviewers to help support your MLR/PRC team?
OSR provides the following:
- Expert Reviewers - 10-15+ Years Experience
- Backed by an Experienced Leadership Team
- Flexible Review Coverage - No Minimum Hours
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NEW in 2019:
- Recruit + Place + Support
- Reviewer Mentoring Program
- Review on Demand
Contact OSR to discuss your needs at OneSourceRegulatory.com
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Information To Help With Better Decisions
MyIndago provides the following benefits:
- A single place to search and find answers to important questions
- Unmatched search capabilities for letters, promotional materials and health authority information
- Ability to annotate and save documents of interest in the MyLibrary feature for future reference
- Opportunity to seek insights from colleagues and OSR
MyIndago - SOLUTIONS
FREE - Unlimited Searches
A&P Enforcement - FDA/CIA/OIG and Guidance Documents,
including:
- FDA Office of Prescription Drug Promotion (OPDP)
- FDA Advertising and Promotional labeling Branch (APLB)
- FDA Center for device and radiological health (CDRH)
- Dietary and Nutrional Supplements
- Center for veterinary machines (CVM), Animal Health
- Cosmetics
- US Corporate integrity agreements and OIG advisory Options
- FDA Advertising and Promotion Regulations/Guidelines Documents
- New enforcement communications will be added upon issuance
FREE - MyLibrary Access
Annotate and Save Documents
FREE - Document Sharing
Send Documents of Interest to Colleagues
Open a Discussion around a Document
Create a free A&P Account
Check out the video now
A&P Enforcement - FDA/CIA/OIG and Guidance Documents, including:
- FDA Office of Prescription Drug Promotion (OPDP)
- FDA Advertising and Promotional labeling Branch (APLB)
- FDA Center for device and radiological health (CDRH)
- Dietary and Nutrional Supplements
- Center for veterinary machines (CVM), Animal Health
- Cosmetics
- US Corporate integrity agreements and OIG advisory Options
- FDA Advertising and Promotion Regulations/Guidelines Documents
- New enforcement communications will be added upon issuance
FREE - MyLibrary Access
Annotate and Save Documents
FREE - Document Sharing
Send Documents of Interest to Colleagues
Open a Discussion around a Document
Create a free A&P AccountCheck out the video now
Pricing plans
Check out our awesome plans tailored to meet your requirements.
Tier 1: Companies Ranked 1-50
HEALTH AUTHORITY DECISIONS Documents (FDA | EMA).
COMING SOON - FDA CBER Products, FDA Advisory Committee Documents)
Tier 2: Companies Ranked 51-100
HEALTH AUTHORITY DECISIONS Documents (FDA | EMA).
COMING SOON - FDA CBER Products, FDA Advisory Committee Documents)
Tier 3: Companies Ranked 101+ and Revenue generating
HEALTH AUTHORITY DECISIONS Documents (FDA | EMA).
COMING SOON - FDA CBER Products, FDA Advisory Committee Documents)
Tier 4: Pre-Revenue
HEALTH AUTHORITY DECISIONS Documents (FDA | EMA).
COMING SOON - FDA CBER Products, FDA Advisory Committee Documents)
Frequently Asked Questions
Q. What is MyIndago?
A single place to search and find answers to important questions. Unmatched search capabilities for letters, promotional materials, and health authority information.
Q. What is the A&P Enforcement Solution?
A FREE Solution that allows you to search all FDA Enforcement Documentation, Annotate, and Save to MyLibrary for future reference.
Q. What is the Health Authority Decision Solution?
This Solution offers a single interface to search FDA Approval Documentation for thousands of approved drugs, compare docs, annotate, and save results!
Q. How do I use the MyLibrary Functionality?
Click the video below to learn about the great features available for saving documents, searches, and organizing your saved information!
Q. What is the MyCommunity?
Click the video to learn more about the Community Forum where current relevant topics are posted, and can be discussed/commented on.
Q. How do I request OSR Consulting Services?
To contact OneSource Regulatory and learn more about our affordable and flexible services and software solutions – Click the link below!
Q. Submit MyIndago Feedback?
Need to report an issue with the site, ask for help, or just want to send feedback, watch the video to find out how!
Q. A&P Case Study
Click the video now to walk through a Case Study Example from the A&P Enforcement Solution!
Q. HA Decision Case Study
Click the video now to walk through a Case Study Example from the HA Decisions Solution!
Get In Touch
If you have any questions, get in touch here.
Telephone
+1 (833) OSR-TEAM
Send email
info@myIndago.com
Terms and Conditions
- TERMS OF USE
- PRIVACY POLICY
- COUNTER NOTIFICATION PROCESS
- CONTACT US
- Nature and purpose of the processing
- Categories of Data Subjects
- Types of Personal Data
- When you use or otherwise interact with the Services
- In e-mail, text and other electronic messages between you and MyIndago.
- When you interact with our advertising and applications on third-party websites and services, if those applications or advertising include links to this policy.
- us offline or through any other means, including on any other Services operated by the Company or any third party (including our affiliates and subsidiaries); or
- any third party (including our affiliates and subsidiaries), including through any application or content (including advertising) that may link to or be accessible from or via the Services.
- by which you may be personally identified, such as name, postal address, e-mail address, telephone number, IP address, unique device IDs, or ANY OTHER INFORMATION THE SERVICES COLLECT THAT IS DEFINED AS PERSONAL OR PERSONALLY IDENTIFIABLE INFORMATION UNDER AN APPLICABLE LAW (“Personal Information”);
- that is about you but does not uniquely identify you, and/or
- non-identifying information about your internet connection, the equipment you use to access our Services and usage details.
- Directly from you when you provide it to us.
- Automatically as you use the Services. Information collected automatically may include usage details, IP addresses and information collected through cookies, web beacons and other tracking technologies.
- From third parties, for example, our business partners.
- Username
- Password
- Email Address
- Your full name
- Professional address
- Position / Title
- Professional phone number
- Professional email address.
- i) Web Server Logs
- Your device’s Internet Protocol (IP) address
- The name of your device’s Internet service provider
- The city, state, and country from which your device accessed MyIndago
- The kind of browser or device used to access MyIndago databases or the MyIndago website
- The way your device navigates through the MyIndago database or MyIndago website
- The date and time of usage
- The web page from which your device arrived at our website(s)
- The content you viewed on our website(s) and/or when using MyIndago
- Searches/queries that you conducted via our website(s)
- ii) Locally Stored Data from Browsers and Devices
- Details of your use of our Services, including traffic data, location data, and other communication data and the resources that you access and use on the Services.
- Information about your computer and internet connection, including your IP address, operating system and browser type.
- Estimate our audience size and usage patterns.
- Store information about your preferences, allowing us to customize our Services according to your individual interests.
- Speed up your searches.
- Recognize you when you return to our Services.
- Cookies (or browser cookies). A cookie is a small file placed on the hard drive of your computer. You may refuse to accept browser cookies by activating the appropriate setting on your browser. However, if you select this setting you may be unable to access or use certain parts of our Services. Unless you have adjusted your browser setting so that it will refuse cookies, our system will issue cookies when you use our Services.
- Flash Cookies. Certain features of the Services may use local stored objects (or Flash cookies) to collect and store information about your preferences and navigation to, from and on the Services. Flash cookies are not managed by the same browser settings as are used for browser cookies.
- Web Beacons. Certain portions of the Services may contain small electronic files known as web beacons (also referred to as clear gifs. pixel tags and single-pixel gifs) that permit the Company, for example, to count users who have visited those pages or opened an e-mail and for other related Services statistics (for example, recording the popularity of certain Services content and verifying system and server integrity).
- (1) How We Process Your Information
- To provide, improve, customize, and support our Services;
- To transfer to, transmit to, store in, or process in the United States and other countries; and
- To communicate with you, for example, on Services-related issues.
- Information you allow us to receive when you subscribe to MyIndago, so we can provide the Services to you
- For providing measurement, analytics, and other business services. The legitimate interests we rely on for this processing are:
- To provide accurate and reliable reporting to businesses and other partners, to ensure accurate pricing and statistics on performance, and to demonstrate the value our partners realize using our Services; and
- In the interests of businesses and other partners to help them understand their customers and improve their businesses, validate our pricing models, and evaluate the effectiveness and distribution of their services and messages, and understand how people interact with them on our Services.
- For providing marketing communications to you. The legitimate interests we rely on for this processing are:
- To promote MyIndago and conduct direct marketing.
- For sharing information with others including law enforcement and to respond to legal requests. The legitimate interests we rely on for this processing are:
- To prevent and address fraud, unauthorized use of MyIndago, violations of our terms and policies, or other harmful or illegal activity; to protect ourselves (including our rights, property or products), our users or others, including as part of investigations or regulatory inquiries; or to prevent death or imminent bodily harm.
- For sharing information with OneSource Regulatory Technology’s business partners and prospective business partners. The legitimate interests we rely on for this processing are:
- OneSource Regulatory Technology’s operation of its day-to-day business, and ability to plan and execute strategic corporate transactions, including mergers
- For processing data when the law requires it, including, for example, if there is a valid legal request for certain data.
- To provide our Services and its contents to you.
- To provide you with information, products or new Services that you request from us.
- To provide you with information about our Services.
- To provide you with notices about your account/subscription, including expiration and renewal notices.
- To carry out our obligations and enforce our rights arising from any contracts entered into between you and us, including for billing and collection.
- To notify you about changes to our Services or any products or services we offer or provide though it.
- To allow you to participate in interactive features on our Services.
- In furtherance of our legitimate interests, as described in this Privacy Policy.
- To comply with applicable law and our legal obligations.
- To fulfill any purpose for which you provide it.
- For any other purpose with your consent.
- We may make personal and OSR usage information available to all OSR entities and unaffiliated trusted third parties in certain situations, for example:
- to third party agents, service providers, and/or contractors who may perform certain functions or services, for example:
- helping us promote our products and services, as described in the Marketing section;
- billing, accounts receivable/payable functions; and/or
- content acquisition and licensing services
- to enforce our Terms of Use.
- to meet our obligations to content and technology providers;
- as needed in connection with the transfer of our business assets (for example, if we are acquired by another company or if we are liquidated during bankruptcy proceedings);
- although unlikely, a trusted third party may need to access Personal Information in connection with a digital forensic investigation of a potential security incident;
- as required by law in a matter of public safety or policy, or if we believe in good faith that sharing such data is necessary to protect our rights or property.
- Your information may also be used for marketing purposes.
- For example, we may use your information to send you newsletters, other publications, conference invitations, and/or communications about products and services that we believe may be of interest to you. We may also share your information with third party agents, service providers, and/or contractors who help us promote our products and services.
- If you do not want to receive such materials, invitations or information about our products or services, you can update your preferences at any time. Your options include updating your account via the Edit Profile option (where applicable), unsubscribing from all marketing emails with this form, and/or using the “unsubscribe” mechanism in the emails you receive from us.
- If you have any additional questions regarding your subscriptions or use of your information for marketing purposes, please contact the info@MyIndago.com
- We may also disclose your information to our contractors, service providers and other third parties we use to support our business and who are bound by contractual obligations to keep Personal Information confidential and use it only for the purposes for which we disclose it to them, based on (1) our legitimate interests in conducting the day-to-day operations of our business, and (2) in order to fulfill requests made by you. The third-parties to whom OneSource Regulatory Technology discloses your Personal Information, and the type of information disclosed, is as follows:
- Description of Services
- - Google Analytics
- Description of Services
- Information Disclosed
- Device Identifiers
- MAC Address
- IP Address
- Unique Identifiers
- HTTP Header
- See more information about the type information collected by Google Analytics at
- https://support.google.com/analytics/answer/6004245?hl=en.
- See more information about the type information collected by Google Analytics at
- https://support.google.com/analytics/answer/6004245?hl=en.
- - GSuite
- OSR uses Google’s GSuite email services to communicate with Website visitors who use the Website to contact OSR. As a result, any information Website visitors include in such communications will be shared with Google.
- Other information may be collected by GSuite under its own Privacy Policy, available at https://gsuite.google.com/faq/security/
- Description of Services
- When a file or correspondence of any type is received by OSR from Website visitors, it may be recorded within Insightly for OSR’s internal business metric purposes only.
- Information Disclosed
- Any information disclosed by you to OSR may be shared with Insightly when OSR uses Insightly’s CRM services.
- Other information may be collected by Insightly under its own Privacy Policy, available at https://www.insightly.com/privacy-policy/
- Description of Services
- Meltwater runs its analytics/news platform off of Google Analytics. Meltwater helps OSR with targeted emails to Website visitors about OSR services they may potentially be interested in.
- Information Disclosed
- Name
- Email Address
- Phone Number
- Tracking Technologies and Advertising.
- We do not control third parties’ collection or use of your information to serve interest-based advertising. However these third parties may provide you with ways to choose not to have your information collected or used in this way. You can opt out of receiving targeted ads from members of the Network Advertising Initiative (“NAI”) on the NAI’s Services.
- your physical or electronic signature
- identification of the copyrighted work claimed to have been infringed
- information which will help us locate the material on our product or service
- your complete contact information, including your name, address, telephone number, and email address
- a statement that you have a good faith belief that use of the material in the manner complained of is not authorized by the copyright owner, its agent, or the law
- a statement that the information in the notification is accurate, and under penalty of perjury, that you are authorized to act as the owner or on behalf of the owner of an exclusive right that is allegedly infringed.
- your physical or electronic signature
- identification of the copyrighted work claimed to have been infringed
- information which will help us locate the material on our product or service
- your complete contact information, including your name, address, telephone number, and email address
- a statement that you have a good faith belief that use of the material in the manner complained of is not authorized by the copyright owner, its agent, or the law
- a statement that you consent to the jurisdiction of Federal District Court for the judicial district in which your address is located, or if you are outside the United States, the judicial district in which we are located, and that you will accept service of process from the person who contacted us regarding the alleged infringement person, or his or her agent.
TERMS OF USE
MYINDAGOSMPROFESSIONAL SERVICES TERMS
These MyIndago Professional Services Terms (the “Terms”), along with any amendments and attachments hereto, together with the terms of your MyIndago License and Terms of Use, or any other agreement between you and OneSource Regulatory (as defined below) setting forth the terms of your use of the MyIndago Website or other software made available to you by OneSource Regulatory, (the “Agreement”), into which these Terms are hereby incorporated by reference, will govern any installation, implementation, customization, training, customized and/or customer-specific support, or other consulting or professional services (collectively, “Professional Services”) as further described in these Terms and as specified in one or more statements of work (“SOWs”) provided by OneSource Regulatory to Customer. THESE TERMS, TOGETHER WITH THE AGREEMENT OF WHICH THEY FORM A PART, FORM A LEGALLY BINDING AGREEMENT BETWEEN THE COMPANY ON WHOSE BEHALF YOU ARE SEEKING PROFESSIONAL SERVICES AND ARE ACCEPTING THESE TERMS OF USE (“CUSTOMER” OR “YOU”), AND ONESOURCE REGULATORY TECHNOLOGY, LLC, A DELAWARE LIMITED LIABILITY COMPANY HAVING A PLACE OF BUSINESS AT PO BOX 1047, LIBERTYVILLE IL, USA, 60048 (“ONESOURCE REGULATORY”). BY CLICKING ON “I AGREE,” “I ACCEPT” OR AN EQUIVALENT MESSAGE, YOU ACCEPT THESE TERMS, INCLUDING ALL AMENDMENTS AND ATTACHMENTS HERETO, WITHOUT MODIFICATION AND AGREE TO BE BOUND BY THEM. IF YOU DO NOT ACCEPT THESE TERMS, YOU MAY NOT RECEIVE THE PROFESSIONAL SERVICES.
THE INDIVIDUAL ACCEPTING THIS THESE TERMS ON BEHALF OF CUSTOMER REPRESENTS AND WARRANTS TO ONESOURCE REGULATORY THAT HE OR SHE (i) IS AT LEAST 18 YEARS OF AGE, AND (ii) HAS ALL REQUISITE POWER AND AUTHORITY TO ENTER INTO THESE TERMS ON BEHALF OF CUSTOMER AND TO BIND CUSTOMER TO THE CONDITIONS HEREOF.
All capitalized terms used in these Terms which are not defined herein shall have the meanings set forth in the Agreement.
1. Services. OneSource Regulatory agrees to provide such Professional Services for Customer as are specified in one or more SOWs mutually executed by both parties. Each SOW shall set forth the business terms and requirements governing an engagement for Professional Services, including, without limitation, as applicable, a detailed description of the Professional Services to be performed, deliverables, pricing, payment schedule, specifications, acceptance criteria and/or project timeline. Once a SOW is executed by both parties, it shall become a part of and subject to these Terms and the Agreement. All Professional Services shall be performed by duly qualified personnel, and OneSource Regulatory agrees that its personnel, when performing Professional Services onsite at Customer’s facilities or accessing its networks and systems, will comply with all reasonable security, network/system access and other workplace policies and procedures which have been provided to OneSource Regulatory in writing in advance. Where Professional Services are to be performed onsite at Customer’s facility, Customer is responsible for providing OneSource Regulatory’s personnel with access to workspace and computers, telephones and other equipment as may be reasonably required for the project.
3. Cooperation. The parties agree to cooperate with each other as reasonably necessary for OneSource Regulatory to provide the Professional Services in a timely, uninterrupted fashion. OneSource Regulatory shall not be responsible for any delays in project timelines attributable to Customer’s failure to provide timely assistance, feedback, content, or other interaction or information needed for a project.
4. Payment; Expenses; Acceptance. The fees and payment schedule for each project or engagement shall be as set forth in the applicable SOW. At Customer’s request, OneSource Regulatory shall furnish a good-faith estimate of the total fees and expenses for Customer’s project; Customer acknowledges that such amount is an estimate only and not a binding quote. OneSource Regulatory shall provide Customer with a rate card listing its standard rates for consultants and contractors upon request. OneSource Regulatory may change its rates for consultants and contractors from time to time upon thirty (30) days’ prior notice to Customer (but shall not do so more than once per calendar year). Fees do not include third-party expenses, such as travel and meals, courier service, supplies and equipment, which shall be invoiced to Customer at cost and payable in the same manner as fees. All Professional Services shall be rendered remotely unless otherwise specified in a SOW, and where the SOW does not provide that Professional Services will be rendered onsite at Customer’s facility, Customer shall have the right to pre-approve any travel. If OneSource Regulatory’s personnel are required to travel more than twenty-five (25) miles from OneSource Regulatory’s headquarters, Customer shall also pay for travel time at their then-standard rates. OneSource Regulatory shall provide Client with receipts or similar documentation evidencing all expenses over $25.00. Unless otherwise specified in a SOW, all fees and expenses will be invoiced monthly, and all payments are due within thirty (30) days after the invoice date.
The deliverables furnished under each SOW shall be subject to Customer’s approval according to the procedures below and the acceptance criteria set forth in the applicable SOW. Approval of deliverables shall not be unreasonably withheld and may only be withheld for material verifiable non-conformity to the specifications and acceptance criteria set forth in the applicable SOW. Deliverables may be furnished in stages, and the parties shall cooperate to facilitate the prompt testing and evaluation of all deliverables. Once approval of an intermediate or final deliverable has been given, any further requested changes to such deliverable shall require a change order under Section 5 below. If Customer demonstrates a verifiable material non-conformity in any deliverable, OneSource Regulatory shall correct the non-conformity at its expense and re-submit the deliverable for approval. Following OneSource Regulatory’s completion of the final deliverable under a SOW, Customer shall have fifteen (15) days to test it for conformity. If Customer fails to report a material non-conformity in the final deliverable within the relevant fifteen (15) day approval period, the deliverables shall be deemed accepted and approved. If a SOW does not specify acceptance criteria, then the Professional Services and deliverables provided thereunder shall be deemed accepted upon performance.
5. Changes. All projects costs quoted in a SOW, unless expressly specified in the SOW, are reasonable good-faith estimates by OneSource Regulatory based solely on the information provided by Customer thus far, the specifications set forth in the SOW and the other requirements therein. Changes in specifications, data, functionality, technology or other requirements requested by Customer, or discovery of material information not previously disclosed to OneSource Regulatory, may impact scope of work and project cost and thus may require execution of a change order or separate SOW. OneSource Regulatory shall not be required to deviate from the project scope or other requirements known as of the effective date of a SOW, or set forth in these Terms, unless and until both it and Customer have executed a mutually acceptable change order or amendment. Any work outside the scope of a SOW will be billed at OneSource Regulatory’s then-current hourly rates.
6. Limited Warranty; Disclaimer.OneSource Regulatory warrants that (i) will provide the Professional Services in a competent and professional manner; and (ii) in performing the Professional Services, it will comply with all laws and regulations (including employment- and workplace safety-related laws and regulations) generally applicable to OneSource Regulatory’s business as a technology service provider. OTHERWISE, ONESOURCE REGULATORY MAKES NO REPRESENTATIONS OR WARRANTIES, WHETHER EXPRESS OR IMPLIED, CONCERNING THE PROFESSIONAL SERVICES OR THE WORK PRODUCT PRODUCED AS A RESULT OF THE PROFESSIONAL SERVICES, AND ALL SUCH REPRESENTATIONS AND WARRANTIES (INCLUDING ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT) ARE HEREBY DISCLAIMED. WITHOUT LIMITING THE FOREGOING, ALL DELIVERABLES ARE PROVIDED STRICTLY “AS IS.”
7. Ownership; License. Unless otherwise expressly specified in a SOW, all software, documentation, other works of authorship, inventions, ideas, technology, concepts, processes, know-how, rules, protocols, methodologies, data or other materials or information created, conceived, developed or reduced to practice by OneSource Regulatory, either alone or in conjunction with Customer or a third party, in connection with or as a result of the Professional Services (collectively, the “Work Product”), including without limitation,any copyrights, patents, trademarks, service marks, trade names, trade dress, trade secrets and any other proprietary rights that are associated with the foregoing materials throughout the world,shall be owned by OneSource Regulatory and shall constitute its Confidential Information. Upon Customer’s full payment of the amounts invoiced for the relevant Professional Services, OneSource Regulatorygrants Customer a limited, worldwide, non-exclusive, non-transferable, fully paid up right and license (with no right to sublicense) for its employees and authorized agents to usethe Work Product in connection with Customer’s permitted use of the MyIndago Website and in accordance with the terms of the Agreement. Customer may use the Work Product only for its internal organizational purposes, may not provide outsourcing, service bureau, application service provider or similar services to third parties and also may not distribute the Work Product to third parties. Customer shall be responsible for all acts and omissions of persons who use the Work Product and for ensuring their compliance with the Agreement.Notwithstanding anything in this Section 7 to the contrary, Customer shall retain exclusive ownership of all data and other materials and information provided to OneSource Regulatory in connection with the Professional Services (collectively, the “Customer Materials”), including without limitation all copyrights, patents, trademarks, service marks, trade names, trade dress, trade secrets and any other proprietary rights that are associated with the Customer Materials throughout the world. Within fifteen (15) days after any termination of the Agreement or of a SOW for Professional Services, OneSource Regulatory shall return all tangible Customer Materials to Customer and delete or destroy all data and other intangible Customer Materials, at Customer’s direction.
8. Non-Solicitation.During the term of the Agreement and for twelve (12) months thereafter, neither party shall, directly or indirectly, on behalf of itself or a third party, solicit or induce any employee of the other party to terminate his or her employment relationship with such other party. However, this Section 8 shall not prohibit any job advertisement or other generalized communication not targeted at the employees of the other party.
MYINDAGOSMLICENSE AND TERMS OF USE
Last Updated: August 20th, 2019
THE APPLICABLE SECTIONS OF THIS MYINDAGO LICENSE AND TERMS OF USE, ALONG WITH ALL AMENDMENTS AND ATTACHMENTS HERETO, GOVERN YOUR SUBSCRIPTION TO THE MYINDAGO SOFTWARE-AS-A-SERVICE APPLICATION (TOGETHER WITH ANY UPDATES, MODIFICATIONS, CUSTOMIZATIONS, CORRECTIONS OR ENHANCEMENTS WHICH BECOME PART OF SUCH APPLICATION ANDALL OTHER RELATED SERVICES, THE “MYINDAGO WEBSITE”), AS WELL AS YOUR USE OF THE FREE BETA VERSION OF THE MYINDAGO WEBSITE, IF AVAILABLE (TOGETHER WITH ANY UPDATES, MODIFICATIONS, CUSTOMIZATIONS, CORRECTIONS OR ENHANCEMENTS WHICH BECOME PART OF SUCH APPLICATION ANDALL OTHER RELATED SERVICES, THE “MYINDAGO BETA”). THIS LICENSE AND TERMS OF USE FORMS A LEGALLY BINDING AGREEMENT BETWEEN THE COMPANY ON WHOSE BEHALF YOU WISH TO USE THE MYINDAGO WEBSITE AND/OR THE MYINDAGO BETA AND ARE ACCEPTING THIS LICENSE AND TERMS OF USE (“CUSTOMER” OR “YOU”), AND ONESOURCE REGULATORY TECHNOLOGY, LLC, A DELAWARE LIMITED LIABILITY COMPANY HAVING A PLACE OF BUSINESS AT PO BOX 1047, LIBERTYVILLE IL, USA, 60048 (“ONESOURCE REGULATORY”). BY CLICKING ON “I AGREE,” “I ACCEPT” OR AN EQUIVALENT MESSAGE, YOU ACCEPT THE TERMS OF THIS LICENSE AND TERMS OF USE, INCLUDING ALL AMENDMENTS AND ATTACHMENTS HERETO, WITHOUT MODIFICATION AND AGREE TO BE BOUND BY THEM. IF YOU DO NOT ACCEPT THE TERMS OF THIS LICENSE AND TERMS OF USE, YOU MAY NOT ACTIVATE OR USE THE MYINDAGO WEBSITE OR THE MYINDAGO BETA.
THE INDIVIDUAL ACCEPTING THIS LICENSE AND TERMS OF USE ON BEHALF OF CUSTOMER REPRESENTS AND WARRANTS TO ONESOURCE REGULATORY THAT HE OR SHE (i) IS AT LEAST 18 YEARS OF AGE, AND (ii) HAS ALL REQUISITE POWER AND AUTHORITY TO ENTER INTO THIS LICENSE AND TERMS OF USE ON BEHALF OF CUSTOMER AND TO BIND CUSTOMER TO THE TERMS HEREOF.
CUSTOMER FURTHER AGREES TO THE DATA PROCESSING TERMS DESCRIBED IN EXHIBIT A HERETO, THE DATA PROCESSING ADDENDUM.
1. Definitions.
As used herein, the following terms shall have the definitions set forth below:
“Affiliate”means an entity that directly or indirectly controls, is controlled by, or is under common control with, a party to this Agreement. For purposes of the foregoing, “control” means ownership or the power to dispose of greater than fifty percent (50%) of any outstanding class of equity securities or interests in the subject entity.
“Agreement” means this License and Terms of Use and all related SOW(s).
“Documentation” means the user manuals and other user documentation for the MyIndago Website or the MyIndago Beta, if any, which may be made available electronically by OneSource Regulatory or as otherwise may be provided by OneSource Regulatory to Customer.
“Effective Date” means the date that this License and Terms of Use is accepted on behalf of Customer, as provided in the preamble hereto.
“MyIndago Professional Service Terms” means the additional terms applicable to OneSource Regulatory’s provision of professional services to Customer under one or more SOWs, available at www.OneSourceRegulatory.com
“Subscription Term”shall mean the term of Customer’s subscription to use the MyIndago Website.
“Support Services” shall have mean maintenance and support for the MyIndago Website, as provided by OneSource Regulatory from time to time and described more fully below, and (if applicable) in the body of a SOW, and as further governed by MyIndago’s Professional Service Terms.
“SOW(s)” means any written or electronic OneSource Regulatory statement of work (including an online subscription form) submitted by Customer and accepted by OneSource Regulatory, evidencing the purchase of a subscription to use the MyIndago Website and (if applicable) setting forth a description of, and business terms regarding, any related professional services being provided by OneSource Regulatory.
“User”means an individual under the control of Customer to whom Customer has issued a personal user ID and password to access and use the MyIndago Website and/or the MyIndago Beta. User does not mean a corporation, company, partnership, association, entity or organization.
2. License Grant and Restrictions.
2.1 License. Subject to the terms and limitations set forth in this Agreement, and provided that OneSource Regulatory has received timely payment of all fees owed under this Agreement, OneSource Regulatory hereby grants Customer (i) a limited, revocable, non-transferable (except in connection with a permitted assignment of this Agreement), non-sublicensable (except as expressly permitted in item (ii) herein) license during the Subscription Term to access and use the MyIndago Website and/or MyIndago Beta and Documentation solely for its internal business purposes, and (ii) if applicable, a limited, revocable, non-transferable (except in connection with a permitted assignment of this Agreement), non-sublicensable license during the Subscription Term to grant access to the MyIndago Website and/or MyIndago Beta to employees of Customer. Customer may not make any statements, representations or warranties concerning the MyIndago Website or MyIndago Beta, the Documentation or OneSource Regulatory that are additional to, or inconsistent with, those appearing in this Agreement, and shall have no authority to make any representations or warranties, or incur any other obligation, on OneSource Regulatory’s behalf to any third party. Customer shall be responsible for all acts and omissions of persons who use the MyIndago Website, the MyIndago Beta, and Documentation and for ensuring their compliance with this Agreement. Customer shall immediately notify OneSource Regulatory of any loss or unauthorized access or use of a personal user ID or password.
2.2 Restrictions.
(a) No Service Bureau Use. Customer may use the MyIndago Website and/or MyIndago Beta only for its internal organizational purposes and may not provide outsourcing, service bureau, application service provider or similar services to third parties.
(b) Copies and Modification. Customer may make an unlimited number of copies of the Documentation, and of the pharmaceutical regulatory documents and records made available via the MyIndago Website and/or MyIndago Beta, solely for its internal organizational use. However, Customer may NOT (nor authorize nor permit its employees, agents, independent contractors or any other person or entity to) (A) modify or create derivative works of the MyIndago Website, MyIndago Beta, or Documentation; (B) distribute, re-sell, sublicense or publicly display or perform the MyIndago Website, MyIndago Beta, Documentation, and/or the documents and records made available via the MyIndago Website or MyIndago Beta, or any portion thereof, or any materials or information based upon the foregoing; or (C) decompile, disassemble, or reverse-engineer any portion of the MyIndago Website or MyIndago Beta, otherwise attempt to derive its source code or protocols, or merge or bundle it with any other software, products or services.
(c) Restricted Rights.The MyIndago Website and MyIndago Beta and any related information are commercial computer software and commercial computer software documentation, and, as specified in FAR 12.212 or DFARS 227.7202, and their successors, as applicable, the U.S. federal government’s rights to use, reproduce or disclose such software, documentation and other information are restricted in accordance with the terms and conditions of this Agreement. Use, duplication or disclosure by the U.S. federal government is subject to the restrictions as set forth in subparagraph (c)(1)(ii) of the Rights in Technical Data and Computer Software clause at DFARS 252.227-7013 or subparagraphs (c)(1) and (2) of the Commercial Computer Software-Restricted Rights at 48 CFR 52.227-19, as applicable.
2.3 Reservation of Rights. All rights not expressly granted to Customer are reserved by OneSource Regulatory. Customer shall have no rights to receive any source or object code for the MyIndago Website or MyIndago Beta, nor use the MyIndago Website or MyIndago Beta except as expressly set forth in this Agreement.
2.4Intended Use.Customer acknowledges that the MyIndago Website and MyIndago Beta is intended solely to provide users with an enhanced ability to access pharmaceutical regulatory information from a variety of sources.
3. MyIndago Beta Version
If you are using the MyIndago Beta, you expressly agree and understand that (a) certain sections of this Agreement DO NOT apply to you, as further detailed below, and (b) MyIndago Beta is currently unfinished and may contain defects, and you may experience errors, malfunctions, and/or interruptions or terminations of service. ACCORDINGLY, NOTWITHSTANDING ANYTHING IN THIS AGREEMENT TO THE CONTRARY, YOU AGREE THAT THE MYINDAGO BETA IS PROVIDED “AS IS,” “AS AVAILABLE,” AND “WITH ALL DEFECTS,” AND THAT ONESOURCE REGULATORY HAS NO OBLIGATION TO PROVIDE SUPPORT SERVICES FOR THE MYINDAGO BETA, AND THAT ONESOURCE REGULATORY MAY ADD, REMOVE, REDUCE, OR OTHERWISE MODIFY FEATURES AND/OR FUNCTIONALITY OF THE MYINDAGO BETA AT ANY TIME AND WITHOUT NOTICE TO YOU. ONESOURCE REGULATORY HEREBY DISCLAIMS ANY AND ALL REPRESENTATIONS AND WARRANTIES (EXPRESS OR IMPLIED) CONCERNING THE MYINDAGO BETA, INCLUDING, WITHOUT LIMITATION, THE ACCURACY AND/OR COMPLETENESS OF ALL INFORMATION, CONTENT, AND MATERIALS INCLUDED THEREIN, OR ANY OTHER WEBSITE, SERVICES, AND/OR TOOLS ON OR PROVIDED IN CONNECTION WITH THE MYINDAGO BETA, AND INCLUDING ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, NON-INFRINGEMENT, SECURITY, FREEDOM FROM VIRUSES OR OTHER HARMFUL CODE, OR UNINTERRUPTED OR ERROR-FREE OPERATION. IN ADDITION, TO THE FULLLEST EXTENT PERMISSIBLE UNDER APPLICABLE LAW, ONESOURCE REGULATORY SHALL NOT BE LIABLE FOR ANY DAMAGES IN CONNECTION WITH THE DEVELOPMENT OR USE OF THE MYINDAGO BETA OR ANY OUTAGES, ERRORS, OR DEFECTS THEREIN, INCLUDING, WITHOUT LIMITATION, ANY DIRECT, INDIRECT, SPECIAL, CONSEQUENTIAL, PUNITIVE, OR INCIDENTAL DAMAGES, OR ANY DAMAGES FOR LOST SALES, PROFITS, BUSINESS, OR DATA, WHETHER OR NOT ONESOURCE REGULATORY HAS BEEN ADVISED OF OR HAS REASON TO KNOW ABOUT THE POSSIBILITY OF ANY SUCH DAMAGES. YOU AGREE THAT YOUR USE OF THE MYINDAGO BETA IS ENTIRELY AT YOUR OWN RISK. YOU AGREE THAT EITHER YOU OR ONESOURCE REGULATORY MAY TERMINATE YOUR USE OF THE MYINDAGO BETA AT ANY TIME AND FOR ANY REASON OR NO REASON, INCLUDING BUT NOT LIMITED TO THE TERMINATING PARTY’S OWN CONVENIENCE. YOU EXPRESSLY ACKNOWLEDGE AND AGREE THAT THE FOLLOWING SECTIONS OF THIS AGREEMENT DO NOT APPLY TO THE MYINDAGO BETA AND TO YOUR USE OF THE MYINDAGO BETA: SECTION 5 IN ITS ENTIRETY, SECTIONS 6.1, 6.2, 6.3, 6.4, AND 6.5, SECTIONS 9.1, 9.3, AND 9.4, SECTION 10.1(a), 10.1(b), AND 10.3, AND SECTION 11.1. IN THE EVENT OF ANY CONFLICT OR INCONSISTENCY BETWEEN THIS SECTION 3 AND ANY OTHER PORTION OF THIS AGREEMENT, THIS SECTION 3 SHALL PREVAIL TO THE EXTENT OF SUCH CONFLICT SOLELY WITH RESPECT TO THE MYINDAGO BETRA AND YOUR USE THEREOF. YOU AGREE THA THE LIMITATIONS AND DISCLAIMERS OF LIABILITY PROVIDED ABOVE SHALL APPLY EVEN IF A REMEDY FAILS OF ITS ESSENTIAL PURPOSE.
4. Title.
4.1The MyIndago Website, the MyIndago Beta, and Documentation furnished under this Agreement are licensed, not sold, to Customer. OneSource Regulatory possesses all right, title and interest in and to the MyIndago Website, the MyIndago Beta, the Documentation, and any copyrights, patents, trademarks, service marks, trade names, trade dress, trade secrets and any other proprietary rights that are associated with the MyIndago Website, the MyIndago Beta, or Documentation throughout the world, and Customer acknowledges that it receives no right, title or interest to the MyIndago Website, the MyIndago Beta, or the Documentation except for the limited rights provided within this Agreement. OneSource Regulatory also retains title to any and all copies made of any embodiments or features of the MyIndago Website, the MyIndago Beta, and the Documentation, and upon any termination of this Agreement, all such copies must be returned to OneSource Regulatory or destroyed, at OneSource Regulatory’s instruction.
4.2Customer agrees not to contest OneSource Regulatory’s title and intellectual property rights in or to the MyIndago Website, the MyIndago Beta, and/or Documentation.
4.3Customer shall provide OneSource Regulatory with reasonable information and feedback concerning the performance and results of its use of the MyIndago Website as requested by OneSource Regulatory. Without limiting any of the foregoing, and notwithstanding anything in this Agreement to the contrary, Customer authorizes and instructs OneSource Regulatory to use metrics from Customer’s use of the MyIndago Website and/or the MyIndago Beta internally to improve OneSource Regulatory’s products and services for the benefit of OneSource Regulatory’s customer base, and further authorizes and instructs OneSource Regulatory to aggregate such metrics with other customers’ metrics and disclose the aggregated, non-customer-specific metrics in the form of industry metrics.
5. Ordering MyIndago Website; Support and Maintenance.
5.1Ordering MyIndago Website. An SOW submitted by Customer will be binding on both parties when OneSource Regulatory chooses to accept such SOW electronically or otherwise when the SOW is signed by an authorized representative of each party.
5.2 General Procedures for Support Services.Provided that all fees have been timely paid to Customer, OneSource Regulatory will provide Customer with Support Services, which shall consist of (i) technical support via telephone and e-mail to investigate, diagnose and attempt to remediate outages, errors and defects in the MyIndago Website reported by Customer, (ii) the provision of such updates, bug fixes and new releases for the MyIndago Website that OneSource Regulatory generally provides to customers of the MyIndago Website, and (iii) any other Support Services that OneSource Regulatory may agree to provide to Customer pursuant to a SOW or SOWs, the provision of which shall also be governed by the MyIndago Professional Service Terms. Unless otherwise set forth in an SOW, OneSource Regulatory’s support coverage is available during OneSource Regulatory’s regular business hours. OneSource Regulatory will provide updates, bug fixes and new releases for the MyIndago Website subscribed to by Customer as they are made generally commercially available, but does not guarantee any update frequency or that all problems will be resolved in an update, bug fix or new release. OneSource Regulatory also shall not be required to provide any new modules or substantial additional functionality unless these are subscribed to separately by Customer.
5.3Limitations.OneSource Regulatory shall not be responsible for supporting Customer's own or any third-party software or systems. OneSource Regulatory may, upon reasonable notice, cease providing technical support or limit the availability of such services to customers who, in OneSource Regulatory’s reasonable judgment, are abusing the customer support system. By way of example and not by way of limitation, such abuse may include excessive requests for assistance unrelated to errors in the MyIndago Website or lack of cooperation with the reasonable requests of OneSource Regulatory personnel for error documentation. Support Services will also automatically terminate if the MyIndago Website are modified by any party other than OneSource Regulatory or its authorized representatives or subcontractors. In addition, OneSource Regulatory shall have no obligation to provide error correction for any bug, error or defect that is caused, in whole or in part, by any of the circumstances described in the exclusions from the Product Warranty set forth in Section 8.4 below. Similarly, OneSource Regulatory may require all requests for updates, upgrades and/or further development services not covered by the Support Services to be handled under a separate agreement and statement of work for professional services. Customer understands and agrees that OneSource Regulatory does not, and cannot, represent, warrant, covenant or guarantee that all errors and defects in the MyIndago Website can or will be remediated or corrected or a workaround provided.
6. Payment; Subscription Term; Termination.
6.1 Fees. Subscription fees will be as set forth on each SOW. OneSource Regulatory may modify its pricing at any time, effective at the beginning of any new Subscription Term following Customer’s current one, by notifying Customer in writing or by e-mail at the address then currently associated with Customer’s account at least thirty (30) days in advance. If Customer chooses to continue receiving the MyIndago Website after the price change goes into effect, then it will be deemed to have accepted the price change beginning with the next Subscription Term; if it does not accept the price change, then it may cancel its subscription as described in Section 6.5 below. All fees are payable in advance. If for any reason OneSource Regulatory cannot collect amounts owed under this Agreement when due, OneSource Regulatory, in addition to any other remedies available to it, may immediately suspend or terminate Customer’s access to or use of the MyIndago Website.
6.2 Taxes. Customer shall be responsible for any applicable sales, use, value added or similar taxes payable with respect to Customer’s subscription for the MyIndago Website and/or the MyIndago Beta, or arising out of or in connection with this Agreement, unless such taxes levied or imposed are based upon OneSource Regulatory’s net income. If Customer has tax-exempt status, Customer shall provide written evidence of such status to OneSource Regulatory.
6.3 Billing Disputes. Customer must provide OneSource Regulatory with written notice of any disputed charges within seven (7) days after the disputed charge is incurred. All disputes not raised within this timeframe shall be deemed waived. If a dispute is submitted within this timeframe, Customer is responsible for paying the undisputed portion of the charges on or before the due date. The dispute notice shall set forth in reasonable detail the information concerning the disputed charges and reasons for the dispute.
6.4 General. All amounts due under this Agreement to OneSource Regulatory shall be payable in U.S. dollars. OneSource Regulatory may charge interest on overdue amounts at the rate of one and one-half percent (1.5%) per month or the highest lawful rate, whichever is less. In the event that OneSource Regulatory must utilize a collection agency or institute legal proceedings to collect any fees or other amounts due under this Agreement, Customer shall be liable for all reasonable attorneys’ fees, agency costs and other costs associated therewith.
6.5 Subscription Term; Termination. The initial Subscription Term for the MyIndago Website shall be as set forth on the relevant SOW and shall begin on the date OneSource Regulatory informs Customer that the MyIndago Website is available for Customer’s use. Customer’s subscription shall thereafter automatically renew for successive additional Subscription Terms of equal length, unless Customer’s subscription is cancelled or this Agreement terminated in accordance with the terms hereof. Customer may cancel its subscription for the MyIndago Website at any time by using any cancellation feature provided on the MyIndago Website or by providing written notice to OneSource Regulatory; any such cancellation by Customer shall be effective at the end of the current Subscription Term. OneSource Regulatory may terminate the Agreement and Customer’s subscription for the MyIndago Website (i) for non-payment as provided in Section 6.1 above; (ii) immediately upon notice via e-mail or written notification sent to the current Customer e-mail or business address associated with Customer’s account, if Customer breaches Section 2 above or Section 9.2(iii) below; (iii) upon seven (7) days’ prior notice sent via e-mail or written notification, if Customer materially breaches any other provision of this Agreement and fails to cure such breach during the seven (7) day notice period; (iv) upon one hundred eighty (180) days’ prior e-mail or written notice if OneSource Regulatory discontinues offering the MyIndago Website; or (v) immediately upon e-mail or written notice in the event Customer undergoes a dissolution, liquidation, composition, financial reorganization or recapitalization with creditors, assignment for the benefit of creditors, or the appointment of a receiver, trustee, custodian, or similar agent for Customer’s business or property.
6.6Obligations upon Termination.Upon any cancellation of Customer’s subscription or termination of this Agreement, (i) all licenses granted under this Agreement shall automatically terminate, (ii) Customer agrees to return to OneSource Regulatory or destroy (at OneSource Regulatory’s instruction) all copies of the Documentation in its possession and (if requested by OneSource Regulatory) provide written notification from an officer of Customer to that effect, and (iii) OneSource Regulatory may destroy and/or delete any Customer data retained by OneSource Regulatory.
6.7Survival.In addition to those provisions which by their nature are intended to survive any termination or expiration of this Agreement or any license granted hereunder (including this Section 6.7), Sections 2 (License Grant and Restrictions) (except for the first sentence of Section 2.1), 3 (MyIndago Beta Version), 4 (Title), 6.1-6.4, 7 (Confidentiality), 10 (Indemnification and Infringement) and 11 (Limitation of Warranty and Liability) of this Agreement shall specifically survive such termination or expiration.
7. Confidentiality. Each party (as the “receiving party”) agrees not to permit access to or to disclose the other party’s (the “disclosing party”) Confidential Information, except to the receiving party’s authorized employees and contractors who are bound by confidentiality agreements with terms no less restrictive than those of this Section 7 and who need to use or have access to the disclosing party’s Confidential Information for the purposes contemplated by this Agreement. A receiving party shall use at least the same degree of care in protecting the disclosing party’s Confidential Information as such receiving party generally exercises in protecting its own most valuable proprietary information and shall inform its employees and contractors having access to the disclosing party’s Confidential Information of its confidential nature. In no event shall a receiving party use less than a commercially reasonable degree of care in protecting the disclosing party’s Confidential Information. “Confidential Information” includes documents, data, software and information which, when provided by the disclosing party to the receiving party: a) are clearly identified as “Confidential” or “Proprietary” or are marked with a similar legend; b) are disclosed orally or visually, and identified as Confidential Information at the time of disclosure and confirmed as Confidential Information in writing within ten (10) business days; or c) a reasonable person would understand to be confidential or proprietary at the time of disclosure. The MyIndago Website and Documentation, as well as results of benchmark and other tests run by either party and resulting from use of the MyIndago Website or MyIndago Beta, shall be deemed OneSource Regulatory Confidential Information without any need for any markings or legends, and in addition to the other restrictions in this Section 7, shall not be disclosed to any competitor of OneSource Regulatory. Notwithstanding the foregoing, the receiving party shall have no obligation of confidentiality with respect to any information which the receiving party can demonstrate by written documentation: (a) is already known to the receiving party at the time of disclosure; (b) is or subsequently becomes publicly available through no wrongful act of the receiving party; (c) is disclosed or provided to the receiving party by a third party without restriction and without having violated any confidentiality agreement of any party; or (d) is developed independently by the receiving party without use of or access to the disclosing party’s Confidential Information. In addition, either party may disclose Confidential Information of the other to the extent required by law or a judicial or regulatory order; provided, however, that the party subject to the requirement furnishes the other party with as much advance written notice as possible under the circumstances and cooperates with its efforts to obtain a suitable protective order. If such an order is not obtained, or the party owning the information waives the non-disclosure obligation, the other party may disclose that portion of the Confidential Information which, based on the advice of counsel, is subject to the judicial, legal or regulatory disclosure requirement. Each party shall immediately notify the other of any suspected unauthorized access, use, disclosure, alteration or loss of the other party’s Confidential Information and shall cooperate with such other party’s reasonable requests in connection with investigating and remediating any such incident.
8. Security.Customer acknowledges that the MyIndago Website and the MyIndago Beta will be hosted and delivered from a data center operated by Amazon or another provider which is subject to industry-standard external auditing. (The audit certifications maintained by OneSource Regulatory’s current data center are available at http://aws.amazon.com/security/#certifications.) Such data center will maintain a written information security program incorporating reasonable administrative, physical and technical safeguards, and compliant with all privacy and data security laws and regulations applicable to the provider, designed to protect any non-public personal information stored through the MyIndago Website and the MyIndago Beta from unauthorized disclosure, use, access, alteration or loss.
9. Warranty, Remedy and Restrictions.
9.1Product Warranty.OneSource Regulatory represents and warrants to Customer that: (i) OneSource Regulatory has the legal power and authority to enter into this Agreement; and (ii) the MyIndago Website, as delivered by OneSource Regulatory to Customer and used in accordance with the Documentation, will substantially conform to the specifications as described in its then current Documentation during each Subscription Term (the “Product Warranty”).
9.2Customer Warranty.Customer warrants to OneSource Regulatory that: (i) it has the legal power and authority to enter into this Agreement; (ii) Customer and the Users shall at all times comply with any privacy, data security, and other laws, rules, and regulations applicable to their activities and geographic territory; and (iii) Customer and the Users shall not upload, submit, store, publish or distribute any unlawful, infringing or libelous content or material through the MyIndago Website or the MyIndago Beta, or any content or material that contains viruses, worms, Trojan horses, malware or other surreptitious, harmful or invasive code.
9.3Product Warranty Remedies.As Customer’s sole and exclusive remedy, and OneSource Regulatory’s sole liability, for any breach of the Product Warranty reported by Customer, OneSource Regulatory shall (i) take reasonable steps to correct or repair the MyIndago Website so that it substantially conforms to its applicable Documentation, or (ii) if such correction or repair cannot be effectuated within a reasonable time, as determined by OneSource Regulatory, terminate Customer’s subscription and refund to Customer a pro-rated amount of the prepaid subscription fees for the applicable Subscription Term allocable to the period in which the MyIndago Website could not be used.
9.4Exclusions.OneSource Regulatory shall not be obligated to remedy any outage, failure or defect in the MyIndago Website that cannot be adequately repeated. The Product Warranty also does not apply to any outage, failure or defect in the MyIndago Website that results from (i) Customer’s failure to maintain the proper production environment to access and use the MyIndago Website (including any failure to maintain the systems and applications required by the Documentation), (ii) use of the MyIndago Website in a manner or for a purpose not expressly permitted in this Agreement or the Documentation, (iii) failures of Customer or third-party hardware, software, equipment or networks, (iv) new data or functionality entered dynamically or through formal release process by Customer or third parties, or changes in or upgrades to operating systems, that were not available for testing and not documented in the Documentation, or (v) a Force Majeure Event (as defined in Section 12.5 below). Customer also acknowledges that OneSource Regulatory may modify the MyIndago Website from time to time in its sole discretion, which modification may include the addition or deletion of features and/or functionality. OneSource Regulatory will use reasonable efforts to post a notice on the MyIndago Website or notify Customer by e-mail at least thirty (30) days prior to any changes that may materially reduce or degrade the functionality or user experience of the MyIndago Website.
10. Indemnification and Infringement.
10.1Indemnification.
(a) OneSource Regulatory Indemnity. Provided that all fees and other amounts required by this Agreement have been timely paid, OneSource Regulatory shall, at its expense, defend Customer from any third party claim or demand (a “Claim”) alleging that the MyIndago Website or Documentation infringes any United States patent or copyright of a third party. In connection with any such infringement Claim, OneSource Regulatory shall also pay any damages awarded by a court or approved by OneSource Regulatory in settlement. Should the MyIndago Website or Documentation become, or in OneSource Regulatory’s opinion likely to become, the subject of a claim of infringement or trade secret misappropriation, OneSource Regulatory may, at its option and expense either: (i) procure for Customer the right to continue to use the infringing MyIndago Website or Documentation, or (ii) replace or modify the infringing MyIndago Website or Documentation to make their use non-infringing without loss of substantial functionality. Notwithstanding the foregoing, if OneSource Regulatory, in its sole discretion, determines that neither of the said options is reasonably available to it, OneSource Regulatory, at its option, may terminate Customer’s use of the allegedly-infringing MyIndago Website or Documentation and shall refund to Customer a pro-rated amount of the prepaid subscription fees for the applicable Subscription Term allocable to any period in which the MyIndago Website could not be used.
(b) Infringement Exclusions. Notwithstanding the foregoing, OneSource Regulatory shall have no liability or obligation to Customer with respect to any Claim based on (i) use of the MyIndago Website or Documentation by Customer in combination with other business processes, products, devices, software, services or components which were not furnished to Customer by OneSource Regulatory or included with the MyIndago Website or Documentation, if the infringement would not have occurred but for the combination; (ii) modification or alteration of the MyIndago Website or Documentation by Customer or its agents, if the infringement would not have occurred but for the modification or alteration;(iii) use of the MyIndago Website or Documentation after OneSource Regulatory notifies Customer, pursuant to subsection (a) above, to discontinue use of the MyIndago Website or Documentation due to a potential or alleged infringement; (iv) use of the MyIndago Website by other than authorized Users; (v) use of the MyIndago Website or Documentation for a purpose other than that for which they were designed; or (vi) content, data, materials or specification provided by Customer or any Users.
(c) Customer Indemnity. Customer shall indemnify, defend and hold harmless OneSource Regulatory and its Affiliates harmless from any costs, losses and expenses (including reasonable attorneys’ fees and other litigation expenses) incurred in connection with a Claim (a) relating to an actual or alleged breach by Customer of this Agreement, including but not limited to any breaches of Customer’s obligations under Exhibit A, the Data Processing Addendum, (b) arising from any use by Customer of the MyIndago Website and/or the MyIndago Beta, or (c) arising from any products or services Customer develops which make use of any material, information, or data that Customer obtains from the MyIndago Website and/or the MyIndago Beta.
10.2 Indemnification Process. The foregoing indemnification obligations of each indemnifying party will be dependent on the indemnified party: (i) providing the indemnifying party with prompt written notice of a Claim (provided that failure to so notify will not remove the indemnifying party’s obligation except to the extent it is materially prejudiced thereby); (ii) permitting the indemnifying party to control the defense and settlement of the Claim; (iii) refraining from entering into any settlement or compromise of any such Claim without approval of the indemnifying party; (iv) providing the indemnifying party with reasonable information and assistance for the defense or settlement of the Claim, at the indemnifying party’s expense; and (v) using all commercially reasonable efforts to mitigate any loss, damage or costs related to the Claim.
10.3 Entire Liability.THIS SECTION 10 STATES THE ENTIRE LIABILITY OF ONESOURCE REGULATORY WITH RESPECT TO THE INFRINGEMENT OF ANY COPYRIGHTS, PATENTS, OR OTHER INTELLECTUAL PROPERTY RIGHTS RELATED TO THE MYINDAGO WEBSITE, DOCUMENTATION OR THEIR USE.
11. Limitation of Warranty and Liability.
11.1 Warranty Limitations. EXCEPT FOR THE EXPRESS WARRANTIES MADE IN SECTION 9 (IF APPLICABLE), THE MYINDAGO WEBSITE AND DOCUMENTATION ARE PROVIDED “AS IS,” ONESOURCE REGULATORY MAKES AND CUSTOMER RECEIVES NO OTHER EXPRESS OR IMPLIED WARRANTIES OF ANY KIND, AND ONESOURCE REGULATORY SPECIFICALLY DISCLAIMS AND EXCLUDES ALL OTHER REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, STATUTORY OR OTHERWISE, INCLUDING WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, NON-INFRINGEMENT, FREEDOM FROM VIRUSES OR OTHER HARMFUL CODE, OR UNINTERRUPTED OR ERROR-FREE OPERATION; ANY IMPLIED WARRANTY ARISING FROM COURSE OF PERFORMANCE, COURSE OF DEALING, OR USAGE OF TRADE; OR STATUTORY REMEDY. SPECIFICALLY, WITH REGARD TO THE INFORMATION, CONTENT, AND OTHER MATERIALS ACCESSIBLE VIA THE MYINDAGO WEBSITE (THE “RESOURCES”), ONESOURCE REGULATORY EXPRESSLY DISCLAIMS ANY REPRESENTATION OR WARRANTY OF COMPLETENESS, ACCURACY, AND/OR CURRENTNESS OF ALL SUCH RESOURCES. CUSTOMER SPECIFICALLY ACKNOWLEDGES AND AGREES THAT, AS A RESULT OF (A) THE OPTICAL CHARACTER RECOGNITION TECHNOLOGY USED TO DIGITALLY CONVERT THE RESOURCES, AND (B) CORRECTIONS THAT ONESOURCE REGULATORY MUST OCCASSIONALLY MAKE TO SUCH RESOURCES TO ATTEMPT TO MAKE THE RESOURCES, OR ANY PORTION THEREOF, SEARCHABLE VIA THE MYINDAGO WEBSITE, THE RESOURCES MAY BE ALTERED FROM THEIR ORIGINAL STATE. ONESOURCE REGULATORY EXPRESSLY DISCLAIMS ANY REPRESENTATION OR WARRANTY THAT THE RESOURCES, OR ANY PORTION THEREOF, ARE EXACTLY REPRODUCED FROM THEIR ORIGINAL VERSIONS, ARE SEARCHABLE VIA THE MYINDAGO WEBSITE, OR THAT ANY IMAGES OR OTHER CONTENTS IN THE RESOURCES ARE SEARCHABLE (DUE TO LIMITATIONS INHERENT IN CURRENT OPTICAL CHARACTER RECOGNITION TECHNOLOGY AS WELL AS OTHER FACTORS). NO STATEMENT WHETHER MADE BY ONESOURCE REGULATORY’S EMPLOYEES, AGENTS OR OTHERWISE SHALL BE DEEMED TO BE A WARRANTY BY ONESOURCE REGULATORY FOR ANY PURPOSE OR TO GIVE RISE TO ANY LIABILITY ON THE PART OF ONESOURCE REGULATORY. EXCEPT FOR THE EXPRESS WARRANTIES MADE IN SECTION 9 (IF APPLICABLE), CUSTOMER’S RECEIPT AND USE OF THE MYINDAGO WEBSITE AND DOCUMENTATION ARE ENTIRELY AT CUSTOMER’S OWN RISK.
11.2 Exclusion of Consequential and Related Damages.EXCEPT FOR A PARTY’S BREACH OF ITS CONFIDENTIALITY OBLIGATIONS UNDER SECTION 7, A BREACH BY CUSTOMER OF SECTION 2, 3, OR 4, OR THE PARTIES’ INDEMNIFICATION OBLIGATIONS UNDER SECTION 10, IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER FOR ANY INCIDENTAL, SPECIAL, PUNITIVE OR CONSEQUENTIAL DAMAGES, LOSS OF PROFITS, LOSS OF DATA OR USE OF DATA, OR INTERRUPTION OF BUSINESS OR OPERATIONS ARISING OUT OF OR RELATED TO THIS AGREEMENT AND/OR THE MYINDAGO WEBSITE AND/OR THE MYINDAGO BETA AND/OR ANY RELATED PROFESSIONAL SERVICES BEING PROVIDED BY ONESOURCE REGULATORY TO CUSTOMER, EVEN IF SUCH PARTY OR ITS REPRESENTATIVE HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH LOSS.
11.3Limitation of Liability. EXCEPT FOR A BREACH OF ITS CONFIDENTIALITY OBLIGATIONS UNDER SECTION 7, OR THE PARTIES’ INDEMNIFICATION OBLIGATIONS UNDER SECTION 10, IN NO EVENT WILL ONESOURCE REGULATORY’S AGGREGATE LIABILITY ARISING OUT OF OR RELATED TO THIS AGREEMENT AND/OR THE MYINDAGO WEBSITE AND/OR THE MYINDAGO BETA AND/OR ANY RELATED PROFESSIONAL SERVICES BEING PROVIDED BY ONESOURCE REGULATORY TO CUSTOMER FOR ANY AND ALL CLAIMS AND DAMAGES, WHETHER IN CONTRACT, TORT OR UNDER ANY OTHER THEORY OF LIABILITY, EXCEED THE FEES PAID BY CUSTOMER UNDER THIS AGREEMENT FOR THE SERVICES DURING THE TWELVE (12) MONTH PERIOD IMMEDIATELY PRECEDING THE DATE UPON WHICH THE LAST CLAIM OR DAMAGE AROSE.
11.4 Material Part of Agreement. Customer agrees that the disclaimer of warranties and limitations of liability in this Section 11 are a material inducement and consideration for OneSource Regulatory to enter into this Agreement and provide the MyIndago Website and Documentation at their current pricing. Accordingly, such provisions shall be enforced as written even if a remedy fails of its essential purpose.
12. General.
12.1 Governing Law.This Agreement and any claim, controversy or dispute arising under or related to this Agreement shall be governed in all respects by the laws of the State of Delaware, USA, without giving effect to principles of conflicts of laws. The United Nations Convention for the International Sale of Goods shall not apply to this Agreement. Any controversy or dispute arising under or related to this Agreement shall be adjudicated in the state and federal courts in and for Chicago, Illinois (including their applicable appellate courts), and each party consents to the exercise of jurisdiction and venue by such courts; provided, however, that either party may seek temporary or emergency injunctive relief in any court of competent jurisdiction to protect and preserve its rights in its intellectual property and Confidential Information.
12.2 Notices.All notices or reports shall be in writing and shall be delivered by personal delivery, facsimile transmission, e-mail, overnight mail or by certified or registered mail, return receipt requested, and shall be deemed given upon personal delivery, five days after deposit in the mail, or upon acknowledgment or confirmation of delivery of e-mail or facsimile transmission. Notices to OneSource Regulatory shall be sent to the address set forth in the preamble to this License and Terms of Use (or such other address as OneSource Regulatory designates by notice sent pursuant to this paragraph), and shall be addressed to OneSource Regulatory with a copy (which shall not constitute notice) to the attention of Andrew Baer, Esq., at Baer Crossey McDemus LLC, 1500 Walnut Street, Suite 1400, Philadelphia, PA 19102. All notices to Customer may be sent to the latest business or e-mail address associated with Customer’s account.
12.3 No Agency. The parties to this Agreement are independent contractors and nothing in this Agreement shall be deemed to create a joint venture, partnership, or agency relationship between the parties in this Agreement.
12.4 Injunctive Relief.Each party acknowledges that its breach of Sections 2, 3, 5 or 7 of this Agreement will cause the other party immediate and irreparable damage for which recovery of money damages would be inadequate. Therefore, each party agrees that the other party shall be entitled to injunctive relief to protect its rights under Sections 2, 3, 5, and 7 of this Agreement (in addition to any other remedies available to said party) without the necessity of posting bond.
12.5 Force Majeure. Neither party shall be liable to the other, following notice thereof, for any failure or delay in the performance of its obligations (except for required payments and the parties’ obligations pursuant to Sections 2, 3, 5, and 7 above) for any cause that is beyond the reasonable control of such party, including, without limitation, acts of God, shortages of supplies, labor or materials, strikes and other labor disputes, storms, floods, acts of war or terrorism, third-party hacking and other criminal or malicious activities, utility brown-outs, failures of telecommunications or the Internet, and actions by a governmental authority (such as changes in government codes, ordinances, laws, rules, regulations, or restrictions).
12.6 Waiver.If one party fails to enforce a provision of this Agreement, it shall not be precluded from enforcing the same provision at another time. To be effective any waiver must be in writing and executed by an authorized signatory of the party to be charged.
12.7 Severability.If any provision of this Agreement is deemed unenforceable or invalid by law or by a court decision, the provision shall be changed and interpreted if possible to accomplish the intent of the provision within the constraints of the law. Only that provision that is deemed unenforceable or invalid, and not the entire Agreement, shall be invalidated.
12.8 Assignment. Customer may not assign this Agreement, in whole or in part, to any third party or agency without the prior written consent of OneSource Regulatory. OneSource Regulatory may assign this Agreement without consent to (i) an Affiliate, or (ii) a successor (by merger, consolidation, purchase of assets, reorganization or otherwise) to substantially all of the assets or business of the OneSource Regulatory business unit to which this Agreement relates. OneSource Regulatory may also, without notice, utilize subcontractors and agents to provide aspects of the MyIndago Website and/or MyIndago Beta, provided, however, that OneSource Regulatory shall remain primarily responsible for compliance with its obligations under this Agreement.
12.9 No Conflicting Terms.OneSource Regulatory shall not accept, and this Agreement does not operate as an acceptance of, any different or additional terms and conditions (including in any Customer purchase order or similar document), and this Agreement shall prevail over any such different or additional provisions, of any Customer order or any other Customer originated instruments.
12.10 Entire Agreement; Amendments.This Agreement, including the Data Processing Addendum attached as Exhibit A hereto, any SOWs executed by the parties, and the MyIndago Professional Service Terms, supersedes all previous agreements and understandings, whether oral or written, between Customer and OneSource Regulatory with respect to its subject matter and the use of the MyIndago Website and/or MyIndago Beta. OneSource Regulatory may modify this License and Terms of Use from time to time by posting an updated version of this License and Terms on www.MyIndago.com or by sending notice of the change to Customer via e-mail at the e-mail address currently associated with Customer’s account. With regard to MyIndago Website subscribers only, any such modification shall not take effect for current customers until the end of the then-current Subscription Term. If Customer chooses to continue receiving or using the MyIndago Website or MyIndago Beta after the effective date of the modification, then it will be deemed to have accepted the License and Terms of Use as modified; if it does not accept the changes, then it may cancel its subscription as described in Section 3 or 6.5 above, as applicable. OneSource Regulatory recommends that Customer periodically check the “Last Updated” date of this License and Terms of Use as posted on www.MyIndago.com in order to keep apprised of any changes. Except as expressly provided herein, the Agreement may only be changed in a writing signed by authorized representatives of each party.
12.11 Order of Precedence.In the event of any inconsistencies between this License and Terms of Use and any SOW, the conflict shall be resolved in the following order of priority: (1) the SOW, 2) the MyIndago Professional Service Terms, 3) this License and Terms of Use, and 4) the Data Processing Addendum.
12.12Export Compliance. Regardless of whether Customer is a US-based entity, Customer shall not export or re-export any of the MyIndago Website or MyIndago Beta (in whole or in part) to any country without ensuring that such export complies with the Export Administration Regulations of the U.S. Department of Commerce, or any other agency of the U.S. Government, or similar laws governing the export of software or products of any other government having jurisdiction over such export, re-export, or use, pursuant to any applicable statute, regulation, or governmental order. Customer agrees to remain at all times in full compliance with U.S. Government export policy and regulations and failure of such compliance shall constitute a material breach of this Agreement.
12.13Press Release. OneSource Regulatory may issue a press release regarding Customer’s entry into this Agreement, the contents of which shall be subject to Customer’s prior written consent, which shall not be unreasonably withheld, delayed or conditioned. OneSource Regulatory may also, without consent, refer to Customer as a customer or user of the MyIndago Website and/or MyIndago Beta in marketing materials, trade shows and other promotional or industry-focused communications.
12.14 No Draftsman’s Presumption. The parties acknowledge that each party had the opportunity to engage counsel in connection with drafting, reviewing and negotiating this Agreement and that, accordingly, no draftsman’s presumption or similar rule of construction shall be applied to construe this Agreement in favor of or against either party.
DATA PROCESSING ADDENDUM
This Data Processing Addendum (“DPA”) applies to the provision of services by the Processor (as defined below) to the Controller (as defined below) if the Processor processes (as defined below) personal data (as defined below). This DPA is subject to and made part of the MyIndago License and Terms of Use or other agreement for services, if applicable (together, the “Agreement”), between the parties. By accepting the Agreement or using the services, the Controller agrees to this DPA. The “Processor” means OneSource Regulatory Technology, LLC, a Delaware limited liability company having a place of business at PO Box 1047, Libertyville IL, USA, 60048. The “Controller” means the other party to the Agreement and its Affiliates. All capitalized terms not defined in this DPA shall have the meanings set forth in the Agreement. The Processor and the Controller, intending to be legally bound, agree as follows:
ARTICLE 1. PROCESSING OBJECTIVES
1.1. "GDPR" means Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation), as amended or supplemented from time to time. “Personal data,” “data subject,” “personal data breach,” “supervisory authority” and “processing” (and variations thereof) shall have the meanings assigned to them in the GDPR.
1.2. The Processor undertakes to process personal data on behalf of the Controller in accordance with the Agreement, this DPA and the documented instructions of the Controller, including Exhibit A attached hereto. The processing will be performed exclusively within the framework of the Agreement, and for all such purposes as may be agreed to subsequently, or as otherwise required by applicable law.
1.3. Except as required by applicable law, the Processor shall not use the personal data for any purpose other than as specified by the Controller. The Controller will inform the Processor of any such purposes which may be prohibited by the GDPR.
1.4. All personal data processed on behalf of the Controller shall remain the property of the Controller and/or the applicable data subjects.
ARTICLE 2. PROCESSOR’S OBLIGATIONS
2.1. The Processor represents and warrants that it shall comply with applicable Privacy Laws to the extent applicable to a processor.
2.2. Upon reasonable request, the Processor shall furnish the Controller with reasonable information regarding the measures it has adopted to comply with its obligations under this DPA.
2.3. The Processor shall provide reasonable assistance to the Controller in fulfilling the Controller’s obligations under Articles 35 - 36 of the GDPR.
ARTICLE 3. TRANSMISSION OF PERSONAL DATA
3.1. The Processor may process the personal data in countries outside the European Union. The Processor may transfer the personal data to a country outside the European Union provided that such country guarantees an adequate level of protection and it satisfies the other obligations applicable to it pursuant to this DPA or as otherwise provided by the GDPR, such as through the use of model clauses or the EU-U.S. or Swiss-U.S. Privacy Shield Frameworks.
ARTICLE 4. ALLOCATION OF RESPONSIBILITY
4.1. The Processor shall only be responsible for processing the personal data under the Agreement, this DPA, and otherwise in accordance with the Controller’s documented instructions which are the responsibility of the Controller.
4.2. The Controller represents and warrants that (i) it shall comply with all applicable data protection and privacy laws, including the GDPR (collectively, “Privacy Laws”), (ii) it has a documented valid legal basis for the processing of all personal data processed by the Processor, and (iii) the processing of all data in accordance with this DPA and the Agreement is not unlawful and does not violate any rights of a third party.
4.3. The Controller shall indemnify, defend, and hold harmless the Processor and its Affiliates, and its and their respective managers, directors, officers, employees and representatives from and against all out-of-pocket costs, expenses, fines, fees (including reasonable attorneys’ fees)arising from all third-party claims, demands, or proceedings arising from or related to any actual or alleged processing of personal data by the Processor on behalf of the Controller without a valid legal basis.
ARTICLE 5. ENGAGING OF THIRD PARTIES OR SUBCONTRACTORS
5.1. The Processor may engage any of its Affiliates as sub-processors, and the Processor and the Processor’s Affiliates may engage third-party sub-processors, provided that the Processor or the Processor Affiliate has entered into a written agreement with each such third-party sub-processor containing data protection obligations no less protective than those in this DPA with respect to the protection of the Controller’s personal data to the extent applicable to the nature of the portion of the services being provided in whole or in part by such third-party sub-processor.
5.2. A list of current sub-processors is available at [https://www.myindago.com/TermsCondition/Terms]. If the Processor adds new sub- processors under the general authorization set forth in this clause then the Processor shall notify the Controller by updating [https://www.myindago.com/TermsCondition/Terms]. The Controller’s continued use of the Processor’s services after such notice shall constitute the Controller’s consent to the new sub-processors, unless the Controller objects pursuant to Section 5.3 below.
5.3. The Controller may reasonably object to the Processor’s use of a new sub-processor by notifying the Processor in writing within fifteen (15) days of the Processor’s notice pursuant to Section 5.2 above. If the Controller objects to any such new sub-processor(s), then the Processor may terminate the Agreement upon written notice to the Controller without further liability to the Controller.
5.4. The Processor shall be liable for the acts and omissions of its sub-processors to the same extent as if the Processor were performing the services of each sub-processor directly under the terms of this DPA.
ARTICLE 6. DUTY TO REPORT
6.1. The Processor shall notify the Controller without undue delay after becoming aware of a personal data breach, as defined by Article 4 of the GDPR. Such notice shall include, to the extent reasonably available to the Processor, the information required for the Controller to fulfil its obligations under Articles 33 and 34 of the GDPR.
6.2. The Controller shall be responsible for complying with Articles 33 and 34 of the GDPR. However, the Processor shall provide reasonable assistance in accordance with the GDPR in notifying the relevant supervisory authorities and/or data subjects.
ARTICLE 7. SECURITY
7.1. The Processor shall implement and maintain such appropriate technical and organisational measures as are required by Article 32 of the GDPR that are designed to ensure a level of security that is appropriate to the risk of harm to the data subjects that may result from the processing activities, including, as appropriate, pseudonymization and encryption of personal data, the ability to ensure the ongoing confidentiality, integrity, availability and resilience of systems, the ability to restore the availability of personal data in a timely manner in the event of a physical or technical incident, and a process for regularly evaluating the effectiveness of technical and organizational measures for ensuring the security of the processing.
7.2. The Processor does not guarantee that such technical and organisational measures are effective under all circumstances. The Processor will ensure that such technical and organisational measures are appropriate to the risk, taking into account the state of the art, the sensitivity of the personal data, and the costs and operational impact related to such technical and organisational measures.
7.3. The Controller will only make the personal data available to the Processor if it is assured that the necessary technical and organisational measures have been taken.
7.4. The Processor will provide assistance to the Controller in fulfilling the Controller’s obligations under Article 32 of the GDPR by making information reasonable available to the Controller.
ARTICLE 8. HANDLING REQUESTS FROM INVOLVED PARTIES
8.1. If a data subject contacts the Processor with respect to the data subject rights under the GDPR, the Processor shall instruct the data subject to contact the Controller. The Controller shall be responsible for responding to and complying with any such data subject’s rights requests made under the GDPR. The Processor will make good-faith efforts to assist the Controller as reasonably necessary in order to permit the Controller to comply with such requests by the data subjects.
ARTICLE 9. NON-DISCLOSURE AND CONFIDENTIALITY
9.1. The Processor shall implement and maintain technical and organizational measures designed to ensure the confidentiality of the personal data to the extent required by the Agreement. All persons authorized by the Processor to access the personal data shall have committed themselves to confidentiality where applicable.
ARTICLE 10. AUDIT
10.1. Upon Controller’s request, Processor shall provide Controller with documentation demonstrating Processor’s compliance with the requirements of this Data Processing Addendum and the GDPR, which Controller agrees shall constitute confidential information of Processor. Additionally, a supervisory authority may conduct an audit to the extent required by the GDPR.
ARTICLE 11. DURATION AND TERMINATION
11.1. The Processor shall, at the Controller’s choice, destroy or return to the Controller all personal data in the Processor’s possession after the Agreement terminates or expires for any reason, unless otherwise required by applicable law.
11.2. This DPA is entered into for the duration set out in the Agreement. This DPA shall automatically terminate upon the later of (i) the termination or expiration of the Agreement, or (ii) the return or destruction of all personal data of the Controller in the custody or control of the Processor.
11.3. This DPA may only be amended by a written agreement signed by both parties.
11.4. The parties will reasonably cooperate with each other to amend this DPA as necessary to comply with applicable new privacy legislation or regulations.
ARTICLE 12. MISCELLANEOUS
12.1. This DPA shall be governed by the laws of the jurisdiction specified in the Agreement. Venue for any dispute arising between the parties in connection with this DPA shall be in the courts of the jurisdiction specified in the Agreement.
12.2. This DPA shall be construed to enable the parties to be compliant with the terms of the GDPR.
12.3. In the case of any conflict between the Agreement and this DPA, this DPA shall control with respect to the matter in conflict.
DATA AND DATA SUBJECTS
The Processor shall process the personal data described below on behalf of the Data Controller:
The MyIndago Website and MyIndago Beta, operated by Processor, provides the Data Controller with a seamless, enhanced ability to access pharmaceutical regulatory information from a variety of sources.
· Employees of the Controller using the services
Employees:
· Name (first and last)
· Business email address
· Business address, city, state/province, postal code, and country
· IP address
· Cookie data
· Unique identifiers
PRIVACY POLICY
MYINDAGOSM PRIVACY POLICY
Last Updated on April 1, 2019. This privacy policy is effective immediately.
Introduction
Thank you for using MyIndago. We are committed to protecting your privacy and, for that reason, we have adopted this Privacy Policy to explain our data collection, use, and disclosure practices for the MyIndago services (including the MyIndago Services, and the full and beta versions of MyIndago’s web-based applications, and any other related and products and services provided by MyIndago) (collectively, the “Services” or “MyIndago”). The Services are owned and operated by OneSource Regulatory Technology, LLC (OneSource Regulatory LLC, OSR), a Delaware limited liability company (“the “Company”).
We respect your privacy and are committed to protecting it through our compliance with this policy.
This policy applies to information we collect:
It does not apply to information collected by:
Please read this policy carefully to understand our policies and practices regarding your information and how we will treat it.
By accessing or using the Services and clicking “agree,” “accept,” or something equivalent, you consent to this Privacy Policy. Information gathered through the Services may be transferred, used, and stored in the United States or in other countries where our service providers or we are located. If you use the Services, you agree and consent to the transfer, use, and storage of your Personal Information (as defined below) in those countries. The data protection and other laws of the United States and other countries might not be as comprehensive as those in your country. You agree that all transactions relating to the Services are deemed to occur in the United States, where our servers are located.
Children Under the Age of 13
Information We Collect About You and How We Collect It
We collect several types of information from and about users of our Services, including information:
We collect this information:
Information You Provide to Us.
We may collect Personal Information and non-personal information in various ways, including directly from you (for example, when you subscribe to the Services, register your account, or sign up for a newsletter), from our web server logs, and through cookies or other website tracking tools.
When you register an account to use MyIndago, we collect the following information from you, which is required to set up a MyIndago account:
If you purchase, contact us about or express interest in the Services, we may ask you to provide some Personal Information, for example:
We may use this information in a contact database for future reference if needed, which may then be used as described in this Privacy Policy.
If you are requesting help with technical issues, we may also ask you to provide information about your computer, computer system, and/or the issues you are trying to resolve. This information is necessary to help us answer your questions. We may record your requests and our responses for logging and quality control purposes.
When you use the Services, our servers may automatically capture and save certain information electronically. These server logs include information about your device’s use of the Services or visits to the MyIndago website(s) (“your device” may include a desktop or laptop computer, mobile device or similar device).
Examples of the information collected by our servers include:
The information collected via web servers is not collected or accessible through the MyIndago dashboard, but is collected through Google Analytics, which we can access through our Google Analytics account. Such information helps us to administer our website(s), analyze their usage, improve their content, protect content from inappropriate uses, and help our websites better operate.
We may collect and store information (including Personal Information) locally on your device using mechanisms such as browser web storage (including HTML 5) and application data caches.
Information We Collect Through Automatic Data Collection Technologies.
As you navigate through and interact with our Services, we may use automatic data collection technologies to collect certain information about your equipment, browsing actions and patterns, including:
We also may use these technologies to collect information about your online activities over time and across third-party websites or other online services (behavioral tracking). The information we collect automatically is statistical data and does not include Personal Information, but we may maintain it or associate it with Personal Information we collect in other ways or receive from third parties. It helps us to improve our Services and to deliver a better and more personalized service, including by enabling us to:
The technologies we use for this automatic data collection may include:
We do not collect Personal Information automatically, but we may tie this information to Personal Information about you that we collect from other sources or you provide to us.
European Union Residents
If you reside in a country in the European Economic Area or in Switzerland, then information we collect from you may be subject to Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (the “GDPR”)) and the following additional information is provided for your benefit.
The controller of the personal data collected through the Services is either (a) the entity that has executed the MyIndago License and Terms of Use, on whose behalf you are using the Services, or (b) if you are not affiliated with an entity that has executed the MyIndago License and Terms of Use:
OneSource Regulatory Technology, LLC
Po Box 1047
Libertyville IL, USA, 60048
If you use the Services, you acknowledge that your personal data is being processed pursuant to the following lawful bases (as further detailed below): your consent, OneSource Regulatory Technology’s legitimate interests, to fulfill requests made by you, and compliance with applicable law. You further acknowledge and consent to your information that is gathered through the Services being transferred to, used in, and stored in the United States.
You hereby consent to the processing of your personal data as described in this Privacy Policy, including the transfer, use, and storage of your personal data in the United States. The data protection and other laws of the United States and other countries might not be as comprehensive as those in your country. You may withdraw your consent at any time by following the instructions in the Accessing/Updating/Deleting Your Personal Information section below, but this will not affect the lawfulness of processing based on consent before its withdrawal. However, if you withdraw your consent or decline to provide personal data to us, you may be unable to use the Services. You have the right to file a complaint relating to the processing of personal data with a supervisory authority.
Under European law, companies must have a legal basis to process data. You have particular rights available to you depending on which legal basis we use, and we've explained these below. You always have the right to request access to, rectification of, and erasure of your data under the GDPR. To exercise your rights, see the “Accessing/Updating/Deleting Your Personal Information” section of this Privacy Policy.
For all people who have legal capacity to enter into an enforceable contract, we process data as necessary to perform our contracts with you. We describe the Services for which this data processing is necessary throughout this Privacy Policy and in our MyIndago License and Terms of Use (the “Terms”). The main uses of your data necessary to provide our Services are:
We'll use the data we have to provide these Services; if you choose not to provide certain data, the quality of your experience using MyIndago may be impacted.
When we process data you provide to us as necessary to provide the Services to you, you have the right to port it under the GDPR. To exercise your rights, see the “Accessing/Updating/Deleting Your Personal Information” section of this Privacy Policy.
The other legal bases we rely on in certain instances when processing your data are:
Your Consent:
When we process data you provide to us based on your consent, you have the right to withdraw your consent at any time and to port that data you provide to us, under the GDPR. To exercise your rights, see the “Accessing/Updating/Deleting Your Personal Information” section of this Privacy Policy.
Our legitimate interests or the legitimate interests of a third party, where not outweighed by your interests or fundamental rights and freedoms ("legitimate interests"):
You have the right to object to, and seek restriction of, such processing; to exercise your rights, see the “Accessing/Updating/Deleting Your Personal Information” section of this Privacy Policy.
We will consider several factors when assessing an objection to our processing in furtherance of OneSource Regulatory Technology’s legitimate interests, including: our users' reasonable expectations; the benefits and risks to you, us, other users, or third parties; and other available means to achieve the same purpose that may be less invasive and do not require disproportional effort. Your objection will be upheld, and we will cease processing your information, unless the processing is based on compelling legitimate grounds or is needed for legal reasons.
Compliance with a legal obligation:
Accessing/Updating/Deleting Your Personal Information
If you would like to delete, update, or access the Personal Information we have collected from you, and/or deactivate or delete your OneSource Regulatory Technology account, you may do so by sending an email to info@MyIndago.com. Additionally, if your Personal Information is subject to the GDPR, you may have certain additional rights, including the right of restriction of processing of personal data, and the right to object to the processing of personal data. Please send an e-mail to info@MyIndago.com for more information.
Third-party Use of Cookies and Other Tracking Technologies.
Some content or applications, including advertisements, on the Services are served by third-parties, including advertisers, ad networks and servers, content providers and application providers. These third parties may use cookies alone or in conjunction with web beacons or other tracking technologies to collect information about you when you use our Services. The information they collect may be associated with your Personal Information or they may collect information, including Personal Information, about your online activities over time and across different portions of the Services and other online services. They may use this information to provide you with interest-based (behavioral) advertising or other targeted content.
Subject to the controls offered by your operating system and web browser, you can erase information stored in Cookies, Flash Cookies, and local browser storage at any time, but you may be forced to login to the Services again and you may lose some preferences or settings. You can also set your browser to refuse all website storage or to indicate when it is permitted, but some features of our Services may not function properly without it.
More information about managing Cookies is available here. Cookie management tools provided by your browser may not affect Flash Cookies. More information about managing Flash Cookies is available here. To learn how to manage privacy and storage settings for your local browser storage, please refer to the end user documentation for your browser.
By clicking “agree” on the displayed pop-up at the top of our MyIndago website when you land on the page, you consent to our use of Cookies, local browser storage, and Web Beacons, and you consent to our collection of certain types of your Personal and non-Personal Information using these technologies, specifically any information you submit when signing up for a MyIndago user account.
To help us collect this information, we use the following third-party software and services. We do not control third parties’ tracking technologies or how they may be used. If you have any questions about an advertisement or other targeted content, you should contact the responsible provider directly. These third parties’ collection and use of information is subject to their own privacy policies, which you can read here:
Google Analytics & Google AdWords
Droisys
Insightly CRM
Meltwater
How We Use Your Information
We use information that we collect about you or that you provide to us, including any Personal Information:
We may use the information we have collected from you to enable us to display advertisements to our advertisers’ target audiences. Even though we do not disclose your Personal Information for these purposes without your consent, if you click on or otherwise interact with an advertisement, the advertiser may assume that you meet its target criteria.
Disclosure of Your Information
We may disclose aggregated information about our users, and information that does not identify and is not identifiable to any individual, without restriction. Our policies require our employees, contractors and vendors to protect the confidentiality of any personal information they may access.
We may disclose Personal Information that we collect or you provide as described in this privacy policy:
Droisys
Developer for OSR technology products.
Any information disclosed by you to OSR may be shared with Droisys as OSR uses Droisys to develop and service this site.
OSR uses Google Analytics to track all traffic to the Website. This data is simply reviewed by OSR from time to time to see where OSR can tweak it’s marketing campaigns/Google AdWords.
Insightly
Meltwater
Other information may be collected by Meltwater under its own Privacy Policy, available at https://www.meltwater.com/privacy/
Choices About How We Use and Disclose Your Information
We strive to provide you with choices regarding the Personal Information you provide to us. We have created mechanisms to provide you with the following control over your information:
You can set your browser to refuse all or some Cookies, or to alert you when Cookies are being sent. To learn how you can manage your Flash Cookie settings, visit the Flash player settings page on Adobe’s Services. If you disable or refuse Cookies, please note that some parts of our Services may then be inaccessible or not function properly.
Accessing and Correcting Your Information
You may send us an e-mail via our contact link to request access to, correct or delete any Personal Information that you have provided to us. We cannot delete your Personal Information except by also deleting your user account. We may not accommodate a request to change information if we believe the change would violate any law or legal requirement or cause the information to be incorrect.
If you delete your User Contributions from the Services, copies of your User Contributions may remain viewable in cached and archived pages, or might have been copied or stored by other Services users. Proper access and use of information provided on the Services, including User Contributions, is governed by our terms of use.
Your California Privacy Rights
A California resident who has provided Personal Information to a business with whom he/she has established a business relationship for personal, family, or household purposes (“California Customer”) is entitled to request information about whether the business has disclosed Personal Information to any third parties for the third parties’ direct marketing purposes. In general, if the business has made such a disclosure of Personal Information, upon receipt of a request by a California Customer, the business is required to provide a list of all third parties to whom Personal Information was disclosed in the preceding calendar year, as well as a list of the categories of Personal Information that were disclosed.
However, under the law, a business is not required to provide the above-described lists if the business adopts and discloses to the public (in its privacy policy) a policy of not disclosing a customer’s Personal Information to third parties for their direct marketing purposes unless the customer first affirmatively agrees to the disclosure, as long as the business maintains and discloses this policy. Rather, the business may comply with the law by notifying the customer of his or her right to prevent disclosure of Personal Information to third parties for direct marketing purposes and providing a cost free means to exercise that right. To prevent disclosure of your Personal Information for use in direct marketing by a third party for its own purposes, do not opt in to or authorize such use when you provide Personal Information through the Services. Please note that whenever you allow your Personal Information to be shared with a third party to communicate with you (including OneSource Regulatory LLC and OneSource Regulatory Technology LLC), your information will be subject to that third party’s privacy policy. If you later decide that you do not want that third party to use your information, you will need to contact the third party directly. You should always review the privacy policy of any party that collects your information to determine how that entity will handle your information.
California Customers may request further information about our compliance with California’s privacy law by e-mailing info@MyIndago.com. Please note that we are only required to respond to one request per customer each year, and we are not required to respond to requests made by means other than through this e-mail address.
Data Security
We have implemented measures designed to secure your Personal Information from accidental loss and from unauthorized access, use, alteration and disclosure
The safety and security of your information also depends on you. Where we have given you (or where you have chosen) a password for access to certain parts of our Services, you are responsible for keeping this password confidential. We ask you not to share your password with anyone.
Unfortunately, the transmission of information via the internet is not completely secure. Although we do our best to protect your Personal Information, we cannot guarantee the security of your Personal Information transmitted to our Services. Any transmission of Personal Information is at your own risk. We are not responsible for circumvention of any privacy settings or security measures contained on the Services.
Changes to Our Privacy Policy
It is our policy to post any changes we make to our privacy policy on this page. If we make material changes to how we treat our users’ Personal Information, we will notify you by e-mail to the e-mail address specified in your account and/or through a notice on the Services home page. The date the privacy policy was last revised is identified at the top of the page. You are responsible for ensuring we have an up-to-date active and deliverable e-mail address for you, and for periodically visiting our Services and this privacy policy to check for any changes.
Opting Out
You may decide to discontinue using our Services at any time, and we will be happy to accommodate any of your requests to have your Personal Information erased or deleted from our systems. To opt out or have your Personal Information deleted, please email info@MyIndago.com and let us know that you would like your Personal Information erased and we will do so within 24 hours of your request. You can update your user profile at any time by logging into your MyIndago account, select the user icon in the top right hand corner and select Edit Profile from the dropdown option. You can update your information at any time.
Copyright Notification Information
If you are contacting us about material included on a OneSource Regulatory Technology product or service at the direction of someone outside of OneSource Regulatory Technology, please include the information noted below in your notification. Please consult your legal counsel or review the U.S Digital Millennium Copyright Act see 17 U.S.C. Section 512 to confirm these requirements:
If your notification does not substantially comply with this format, we may be unable to properly analyze and respond. Please remember that knowing misrepresentation that the material or activity is infringing, or that it was removed in error may be liable for damages.
COUNTER NOTIFICATION PROCESS
If you receive a notice that material you posted to a OneSource Regulatory Technology product or services is being blocked or removed due to a copyright infringement allegation, you may send us a counter notice explaining why you believe the blocking or removal is in error. Again, please consult your legal counsel or review the U.S Digital Millennium Copyright Act see 17 U.S.C. Section 512 to confirm these requirements. To be effective, such notice must be in writing and include the following:
Please send your notice to the OneSource Regulatory Technology Copyright Agent (see contact information below):
OneSource Regulatory Technology LLC
Attn: Copyright Services
PO Box 1047
Libertyville, IL, USA 60048
CONTACT US
By mail:
OneSource Regulatory Technology LLC/MyIndago
Attn: Logos
PO Box 1047
Libertyville, IL, USA 60048
By email: info@MyIndago.com or info@OneSourceRegulatory.com
By phone: +1 (833) OSR-TEAM