Our eSTAR interface is changing the game on FDA 510(k) submissions

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Our eSTAR interface is changing the game on FDA 510(k) submissions

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Our eSTAR interface is changing the game on FDA 510(k) submissions

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Our eSTAR interface is changing the game on FDA 510(k) submissions

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Terms & Conditions

Terms & Conditions

Terms & Conditions

Terms & Conditions

Version 1.6

Version 1.6

Last Modified: July 26, 2021

Last Modified: July 26, 2021

PLEASE READ THESE TERMS AND CONDITIONS (“TERMS”) BEFORE USING THE ESSENVIA SAAS PLATFORM (AS DEFINED BELOW). THESE TERMS, INCLUDING ANY CUSTOMER SUBSCRIPTION AGREEMENT OR SERVICE ORDER FORMS THAT REFERENCE THESE TERMS (“ORDER FORMS”) FORM A BINDING AND EXECUTED WRITTEN AGREEMENT (THE “AGREEMENT”) BETWEEN ESSENVIA, INC. (“ESSENVIA”) AND THE ENTITY AGREEING TO THE SUBSCRIPTION AGREEMENT (“USER”). THIS AGREEMENT IS EFFECTIVE AS OF THE DATE YOU CLICK THE “SIGN UP” BUTTON TO SIGN UP TO USE THE ESSENVIA SAAS PLATFORM (OR ANY SIMILAR BUTTON OR LINK OR OTHER MECHANISM AS MAY BE DESIGNATED BY ESSENVIA TO SHOW YOUR ACCEPTANCE OF THIS AGREEMENT, SUCH AS BY SIGNING A CUSTOMER SUBSCRIPTION AGREEMENT OR ORDER FORM) (SUCH DATE, THE “EFFECTIVE DATE”). If you are accepting on behalf of your employer or another entity, you represent and warrant that: (i) you have full legal authority to bind your employer, or the applicable entity, to this Agreement (ii) you have read and understand this Agreement; and (iii) you agree, on behalf of the party that you represent, to be legally bound by this Agreement. ACCEPTANCE OF THIS AGREEMENT IS REQUIRED AS A CONDITION TO PROCEEDING WITH THE ACCESS AND USE OF THE ESSENVIA SAAS PLATFORM. IF YOU DO NOT AGREE TO ALL OF THE TERMS AND CONDITIONS OF THE AGREEMENT of if you do not have the legal authority to bind your employer or the applicable entity, DO NOT CLICK THE “SIGN UP” button AND DO NOT USE THE ESSENVIA SAAS PLATFORM. USER AND ESSENVIA MAY EACH BE REFERRED TO HEREIN AS A “PARTY” IN THESE TERMS, AND ARE, COLLECTIVELY, THE “PARTIES”. ESSENVIA RESERVES THE RIGHT, AT ITS SOLE DISCRETION, TO CHANGE, MODIFY, ADD OR DELETE PORTIONS OF THESE TERMS AT ANY TIME EXCEPT AS EXPRESSLY PROVIDED IN THE ARBITRATION PROVISION BELOW. IF ESSENVIA CHANGES THESE TERMS, IT WILL POST THE CHANGES ON THIS PAGE AND WILL INDICATE AT THE TOP OF THIS PAGE THE DATE THESE TERMS WERE LAST REVISED. YOU SHOULD PERIODICALLY VISIT THIS PAGE TO REVIEW THE CURRENT TERMS SO YOU ARE AWARE OF ANY REVISION TO WHICH YOU ARE BOUND. YOUR CONTINUED USE OF THE ESSENVIA SAAS PLATFORM (AS DEFINED BELOW) AFTER ANY SUCH CHANGES CONSTITUTES YOUR ACCEPTANCE OF THE NEW TERMS. IF YOU DO NOT AGREE TO ABIDE BY THESE OR ANY FUTURE TERMS, DO NOT USE OR ACCESS (OR CONTINUE TO USE OR ACCESS) THE ESSENVIA SAAS PLATFORM. IN ADDITION, WHEN USING CERTAIN SERVICES, YOU SHALL BE SUBJECT TO ANY ADDITIONAL TERMS APPLICABLE TO SUCH SERVICES THAT MAY BE POSTED ON THE SERVICE FROM TIME TO TIME, INCLUDING, WITHOUT LIMITATION, THE PRIVACY POLICY LOCATED HERE. ALL SUCH TERMS ARE HEREBY INCORPORATED BY REFERENCE INTO THESE TERMS. THESE TERMS CONTAIN AN ARBITRATION AGREEMENT, WHICH WILL, WITH LIMITED EXCEPTION, REQUIRE YOU TO SUBMIT CLAIMS YOU HAVE AGAINST ESSENVIA TO BINDING AND FINAL ARBITRATION. UNDER THE ARBITRATION AGREEMENT, (1) YOU WILL BE PERMITTED TO PURSUE CLAIMS AGAINST COMPANY ONLY ON AN INDIVIDUAL BASIS, NOT AS A PLAINTIFF OR CLASS MEMBER IN ANY CLASS OR REPRESENTATIVE ACTION OR PROCEEDING, AND (2) YOU WILL BE PERMITTED TO SEEK RELIEF (INCLUDING MONETARY, INJUNCTIVE, AND DECLARATORY RELIEF) ONLY ON AN INDIVIDUAL BASIS. IN CONSIDERATION OF THE MUTUAL PROMISES BELOW AND OTHER GOOD AND VALUABLE CONSIDERATION THE SUFFICIENCY OF WHICH ARE HEREBY ACKNOWLEDGED, THE PARTIES AGREE AS FOLLOWS:

PLEASE READ THESE TERMS AND CONDITIONS (“TERMS”) BEFORE USING THE ESSENVIA SAAS PLATFORM (AS DEFINED BELOW). THESE TERMS, INCLUDING ANY CUSTOMER SUBSCRIPTION AGREEMENT OR SERVICE ORDER FORMS THAT REFERENCE THESE TERMS (“ORDER FORMS”) FORM A BINDING AND EXECUTED WRITTEN AGREEMENT (THE “AGREEMENT”) BETWEEN ESSENVIA, INC. (“ESSENVIA”) AND THE ENTITY AGREEING TO THE SUBSCRIPTION AGREEMENT (“USER”). THIS AGREEMENT IS EFFECTIVE AS OF THE DATE YOU CLICK THE “SIGN UP” BUTTON TO SIGN UP TO USE THE ESSENVIA SAAS PLATFORM (OR ANY SIMILAR BUTTON OR LINK OR OTHER MECHANISM AS MAY BE DESIGNATED BY ESSENVIA TO SHOW YOUR ACCEPTANCE OF THIS AGREEMENT, SUCH AS BY SIGNING A CUSTOMER SUBSCRIPTION AGREEMENT OR ORDER FORM) (SUCH DATE, THE “EFFECTIVE DATE”). If you are accepting on behalf of your employer or another entity, you represent and warrant that: (i) you have full legal authority to bind your employer, or the applicable entity, to this Agreement (ii) you have read and understand this Agreement; and (iii) you agree, on behalf of the party that you represent, to be legally bound by this Agreement. ACCEPTANCE OF THIS AGREEMENT IS REQUIRED AS A CONDITION TO PROCEEDING WITH THE ACCESS AND USE OF THE ESSENVIA SAAS PLATFORM. IF YOU DO NOT AGREE TO ALL OF THE TERMS AND CONDITIONS OF THE AGREEMENT of if you do not have the legal authority to bind your employer or the applicable entity, DO NOT CLICK THE “SIGN UP” button AND DO NOT USE THE ESSENVIA SAAS PLATFORM. USER AND ESSENVIA MAY EACH BE REFERRED TO HEREIN AS A “PARTY” IN THESE TERMS, AND ARE, COLLECTIVELY, THE “PARTIES”. ESSENVIA RESERVES THE RIGHT, AT ITS SOLE DISCRETION, TO CHANGE, MODIFY, ADD OR DELETE PORTIONS OF THESE TERMS AT ANY TIME EXCEPT AS EXPRESSLY PROVIDED IN THE ARBITRATION PROVISION BELOW. IF ESSENVIA CHANGES THESE TERMS, IT WILL POST THE CHANGES ON THIS PAGE AND WILL INDICATE AT THE TOP OF THIS PAGE THE DATE THESE TERMS WERE LAST REVISED. YOU SHOULD PERIODICALLY VISIT THIS PAGE TO REVIEW THE CURRENT TERMS SO YOU ARE AWARE OF ANY REVISION TO WHICH YOU ARE BOUND. YOUR CONTINUED USE OF THE ESSENVIA SAAS PLATFORM (AS DEFINED BELOW) AFTER ANY SUCH CHANGES CONSTITUTES YOUR ACCEPTANCE OF THE NEW TERMS. IF YOU DO NOT AGREE TO ABIDE BY THESE OR ANY FUTURE TERMS, DO NOT USE OR ACCESS (OR CONTINUE TO USE OR ACCESS) THE ESSENVIA SAAS PLATFORM. IN ADDITION, WHEN USING CERTAIN SERVICES, YOU SHALL BE SUBJECT TO ANY ADDITIONAL TERMS APPLICABLE TO SUCH SERVICES THAT MAY BE POSTED ON THE SERVICE FROM TIME TO TIME, INCLUDING, WITHOUT LIMITATION, THE PRIVACY POLICY LOCATED HERE. ALL SUCH TERMS ARE HEREBY INCORPORATED BY REFERENCE INTO THESE TERMS. THESE TERMS CONTAIN AN ARBITRATION AGREEMENT, WHICH WILL, WITH LIMITED EXCEPTION, REQUIRE YOU TO SUBMIT CLAIMS YOU HAVE AGAINST ESSENVIA TO BINDING AND FINAL ARBITRATION. UNDER THE ARBITRATION AGREEMENT, (1) YOU WILL BE PERMITTED TO PURSUE CLAIMS AGAINST COMPANY ONLY ON AN INDIVIDUAL BASIS, NOT AS A PLAINTIFF OR CLASS MEMBER IN ANY CLASS OR REPRESENTATIVE ACTION OR PROCEEDING, AND (2) YOU WILL BE PERMITTED TO SEEK RELIEF (INCLUDING MONETARY, INJUNCTIVE, AND DECLARATORY RELIEF) ONLY ON AN INDIVIDUAL BASIS. IN CONSIDERATION OF THE MUTUAL PROMISES BELOW AND OTHER GOOD AND VALUABLE CONSIDERATION THE SUFFICIENCY OF WHICH ARE HEREBY ACKNOWLEDGED, THE PARTIES AGREE AS FOLLOWS:

PLEASE READ THESE TERMS AND CONDITIONS (“TERMS”) BEFORE USING THE ESSENVIA SAAS PLATFORM (AS DEFINED BELOW). THESE TERMS, INCLUDING ANY CUSTOMER SUBSCRIPTION AGREEMENT OR SERVICE ORDER FORMS THAT REFERENCE THESE TERMS (“ORDER FORMS”) FORM A BINDING AND EXECUTED WRITTEN AGREEMENT (THE “AGREEMENT”) BETWEEN ESSENVIA, INC. (“ESSENVIA”) AND THE ENTITY AGREEING TO THE SUBSCRIPTION AGREEMENT (“USER”). THIS AGREEMENT IS EFFECTIVE AS OF THE DATE YOU CLICK THE “SIGN UP” BUTTON TO SIGN UP TO USE THE ESSENVIA SAAS PLATFORM (OR ANY SIMILAR BUTTON OR LINK OR OTHER MECHANISM AS MAY BE DESIGNATED BY ESSENVIA TO SHOW YOUR ACCEPTANCE OF THIS AGREEMENT, SUCH AS BY SIGNING A CUSTOMER SUBSCRIPTION AGREEMENT OR ORDER FORM) (SUCH DATE, THE “EFFECTIVE DATE”). If you are accepting on behalf of your employer or another entity, you represent and warrant that: (i) you have full legal authority to bind your employer, or the applicable entity, to this Agreement (ii) you have read and understand this Agreement; and (iii) you agree, on behalf of the party that you represent, to be legally bound by this Agreement. ACCEPTANCE OF THIS AGREEMENT IS REQUIRED AS A CONDITION TO PROCEEDING WITH THE ACCESS AND USE OF THE ESSENVIA SAAS PLATFORM. IF YOU DO NOT AGREE TO ALL OF THE TERMS AND CONDITIONS OF THE AGREEMENT of if you do not have the legal authority to bind your employer or the applicable entity, DO NOT CLICK THE “SIGN UP” button AND DO NOT USE THE ESSENVIA SAAS PLATFORM. USER AND ESSENVIA MAY EACH BE REFERRED TO HEREIN AS A “PARTY” IN THESE TERMS, AND ARE, COLLECTIVELY, THE “PARTIES”. ESSENVIA RESERVES THE RIGHT, AT ITS SOLE DISCRETION, TO CHANGE, MODIFY, ADD OR DELETE PORTIONS OF THESE TERMS AT ANY TIME EXCEPT AS EXPRESSLY PROVIDED IN THE ARBITRATION PROVISION BELOW. IF ESSENVIA CHANGES THESE TERMS, IT WILL POST THE CHANGES ON THIS PAGE AND WILL INDICATE AT THE TOP OF THIS PAGE THE DATE THESE TERMS WERE LAST REVISED. YOU SHOULD PERIODICALLY VISIT THIS PAGE TO REVIEW THE CURRENT TERMS SO YOU ARE AWARE OF ANY REVISION TO WHICH YOU ARE BOUND. YOUR CONTINUED USE OF THE ESSENVIA SAAS PLATFORM (AS DEFINED BELOW) AFTER ANY SUCH CHANGES CONSTITUTES YOUR ACCEPTANCE OF THE NEW TERMS. IF YOU DO NOT AGREE TO ABIDE BY THESE OR ANY FUTURE TERMS, DO NOT USE OR ACCESS (OR CONTINUE TO USE OR ACCESS) THE ESSENVIA SAAS PLATFORM. IN ADDITION, WHEN USING CERTAIN SERVICES, YOU SHALL BE SUBJECT TO ANY ADDITIONAL TERMS APPLICABLE TO SUCH SERVICES THAT MAY BE POSTED ON THE SERVICE FROM TIME TO TIME, INCLUDING, WITHOUT LIMITATION, THE PRIVACY POLICY LOCATED HERE. ALL SUCH TERMS ARE HEREBY INCORPORATED BY REFERENCE INTO THESE TERMS. THESE TERMS CONTAIN AN ARBITRATION AGREEMENT, WHICH WILL, WITH LIMITED EXCEPTION, REQUIRE YOU TO SUBMIT CLAIMS YOU HAVE AGAINST ESSENVIA TO BINDING AND FINAL ARBITRATION. UNDER THE ARBITRATION AGREEMENT, (1) YOU WILL BE PERMITTED TO PURSUE CLAIMS AGAINST COMPANY ONLY ON AN INDIVIDUAL BASIS, NOT AS A PLAINTIFF OR CLASS MEMBER IN ANY CLASS OR REPRESENTATIVE ACTION OR PROCEEDING, AND (2) YOU WILL BE PERMITTED TO SEEK RELIEF (INCLUDING MONETARY, INJUNCTIVE, AND DECLARATORY RELIEF) ONLY ON AN INDIVIDUAL BASIS. IN CONSIDERATION OF THE MUTUAL PROMISES BELOW AND OTHER GOOD AND VALUABLE CONSIDERATION THE SUFFICIENCY OF WHICH ARE HEREBY ACKNOWLEDGED, THE PARTIES AGREE AS FOLLOWS:

BACKGROUND

BACKGROUND

BACKGROUND

Essenvia offers a software-as-a-service platform that allows users in the regulated medical device industry to collaborate, share information among employees, subcontractors and other authorized invitees involved in the applicable 510(k) application project, assemble documents, track progress, and manage the submission of a 510(k) application to the Food and Drug Administration. User wishes to access, and Essenvia is willing to provide User access, to use the Essenvia SaaS Platform on the terms and conditions described in this Agreement.

Essenvia offers a software-as-a-service platform that allows users in the regulated medical device industry to collaborate, share information among employees, subcontractors and other authorized invitees involved in the applicable 510(k) application project, assemble documents, track progress, and manage the submission of a 510(k) application to the Food and Drug Administration. User wishes to access, and Essenvia is willing to provide User access, to use the Essenvia SaaS Platform on the terms and conditions described in this Agreement.

Essenvia offers a software-as-a-service platform that allows users in the regulated medical device industry to collaborate, share information among employees, subcontractors and other authorized invitees involved in the applicable 510(k) application project, assemble documents, track progress, and manage the submission of a 510(k) application to the Food and Drug Administration. User wishes to access, and Essenvia is willing to provide User access, to use the Essenvia SaaS Platform on the terms and conditions described in this Agreement.

DEFINITIONS

DEFINITIONS

DEFINITIONS

The following terms, when used in this Agreement shall have the following meanings: “Essenvia SaaS Platform” means the online software-as-a-service platform established and operated by Essenvia or its affiliates at http://www.essenvia.com (and any associated websites) for the subscription or other access by Essenvia clients and other permitted parties to Essenvia’s Regulatory Submission Manager software-as-a-service for the collaborative preparation, management, submission and tracking of 510(k) applications to the Food and Drug Administration (“FDA”). “Confidential Information“ means, subject to the exceptions set forth in the following sentence, any information or data, regardless of whether it is in tangible form, disclosed by either Party (the “Disclosing Party”) that the Disclosing Party has either marked as confidential or proprietary, or has identified in writing as confidential or proprietary within thirty (30) days of disclosure to the other Party (the “Receiving Party”); provided, however, that a Disclosing Party’s business plans, strategies, technology, research and development, current and prospective customers, billing records, and products or services shall be deemed Confidential Information of the Disclosing Party even if not so marked or identified. Information will not be deemed “Confidential Information” if such information: (a) is known to the Receiving Party prior to receipt from the Disclosing Party directly or indirectly from a source other than one having an obligation of confidentiality to the Disclosing Party; (b) becomes known (independently of disclosure by the Disclosing Party) to the Receiving Party directly or indirectly from a source other than one having an obligation of confidentiality to the Disclosing Party; (c) becomes publicly known or otherwise ceases to be secret or confidential, except through a breach of this Agreement by the Receiving Party; or (d) is independently developed by the Receiving Party. “User Content” means any creative or other content created, developed, submitted or otherwise made available by or on behalf of User using the Essenvia SaaS Platform, including any contributions to any message boards, chat rooms, personal web pages or profiles, forums, bulletin boards or other interactive features offered by the Essenvia SaaS Platform.

The following terms, when used in this Agreement shall have the following meanings: “Essenvia SaaS Platform” means the online software-as-a-service platform established and operated by Essenvia or its affiliates at http://www.essenvia.com (and any associated websites) for the subscription or other access by Essenvia clients and other permitted parties to Essenvia’s Regulatory Submission Manager software-as-a-service for the collaborative preparation, management, submission and tracking of 510(k) applications to the Food and Drug Administration (“FDA”). “Confidential Information“ means, subject to the exceptions set forth in the following sentence, any information or data, regardless of whether it is in tangible form, disclosed by either Party (the “Disclosing Party”) that the Disclosing Party has either marked as confidential or proprietary, or has identified in writing as confidential or proprietary within thirty (30) days of disclosure to the other Party (the “Receiving Party”); provided, however, that a Disclosing Party’s business plans, strategies, technology, research and development, current and prospective customers, billing records, and products or services shall be deemed Confidential Information of the Disclosing Party even if not so marked or identified. Information will not be deemed “Confidential Information” if such information: (a) is known to the Receiving Party prior to receipt from the Disclosing Party directly or indirectly from a source other than one having an obligation of confidentiality to the Disclosing Party; (b) becomes known (independently of disclosure by the Disclosing Party) to the Receiving Party directly or indirectly from a source other than one having an obligation of confidentiality to the Disclosing Party; (c) becomes publicly known or otherwise ceases to be secret or confidential, except through a breach of this Agreement by the Receiving Party; or (d) is independently developed by the Receiving Party. “User Content” means any creative or other content created, developed, submitted or otherwise made available by or on behalf of User using the Essenvia SaaS Platform, including any contributions to any message boards, chat rooms, personal web pages or profiles, forums, bulletin boards or other interactive features offered by the Essenvia SaaS Platform.

The following terms, when used in this Agreement shall have the following meanings: “Essenvia SaaS Platform” means the online software-as-a-service platform established and operated by Essenvia or its affiliates at http://www.essenvia.com (and any associated websites) for the subscription or other access by Essenvia clients and other permitted parties to Essenvia’s Regulatory Submission Manager software-as-a-service for the collaborative preparation, management, submission and tracking of 510(k) applications to the Food and Drug Administration (“FDA”). “Confidential Information“ means, subject to the exceptions set forth in the following sentence, any information or data, regardless of whether it is in tangible form, disclosed by either Party (the “Disclosing Party”) that the Disclosing Party has either marked as confidential or proprietary, or has identified in writing as confidential or proprietary within thirty (30) days of disclosure to the other Party (the “Receiving Party”); provided, however, that a Disclosing Party’s business plans, strategies, technology, research and development, current and prospective customers, billing records, and products or services shall be deemed Confidential Information of the Disclosing Party even if not so marked or identified. Information will not be deemed “Confidential Information” if such information: (a) is known to the Receiving Party prior to receipt from the Disclosing Party directly or indirectly from a source other than one having an obligation of confidentiality to the Disclosing Party; (b) becomes known (independently of disclosure by the Disclosing Party) to the Receiving Party directly or indirectly from a source other than one having an obligation of confidentiality to the Disclosing Party; (c) becomes publicly known or otherwise ceases to be secret or confidential, except through a breach of this Agreement by the Receiving Party; or (d) is independently developed by the Receiving Party. “User Content” means any creative or other content created, developed, submitted or otherwise made available by or on behalf of User using the Essenvia SaaS Platform, including any contributions to any message boards, chat rooms, personal web pages or profiles, forums, bulletin boards or other interactive features offered by the Essenvia SaaS Platform.

ACCESS TO ESSENVIA SAAS PLATFORM; LICENSES.

ACCESS TO ESSENVIA SAAS PLATFORM; LICENSES.

ACCESS TO ESSENVIA SAAS PLATFORM; LICENSES.

2.1 Access to Essenvia SaaS Platform. Subject to the terms and conditions of this Agreement, Essenvia hereby grants User a non-exclusive right to access and use the Essenvia SaaS Platform for its internal business purposes. User shall not license, sublicense, sell, resell, lease, transfer, distribute, time share, or otherwise commercially exploit or make the Essenvia SaaS Platform available to any third party or reverse-engineer, decompile, translate or create derivative works of the Essenvia SaaS Platform in any manner. All ownership rights, title, and interest in and to the Essenvia SaaS Platform, as such may be modified, upgraded, and/or enhanced from time to time (together with all intellectual property rights therein) will remain with and belong exclusively to Essenvia. Essenvia reserves all right, title and interest in and to the Essenvia SaaS Platform not expressly granted to User herein.

Essenvia requires that each User accessing the Platform set up an administrator account. User may specify one or more persons who administer(s) the services and access to the Essenvia SaaS Platform on the User’s behalf (“Administrator(s)”). Administrators have the right to access and to administer individual accounts for users. Additionally, Administrators have the right to view every project created by any of the individuals whose accounts they administer and all projects that such users are invited to. Administrators may also edit login credentials for the accounts they administer, including logging into the Essenvia SaaS Platform or its applications under such accounts or removing such accounts. Administrators are responsible for: (a) maintaining the confidentiality of the password and the Administrator’s account; (b) designating those individuals who are authorized to be Administrators and access the Administrator account(s); and (c) ensuring that all activities that occur in connection with the Administrator account(s) comply with the Terms. User agrees that Essenvia’s responsibilities do not extend to the internal management or administration of any services provided on the Essenvia SaaS Platform.

2.1 Access to Essenvia SaaS Platform. Subject to the terms and conditions of this Agreement, Essenvia hereby grants User a non-exclusive right to access and use the Essenvia SaaS Platform for its internal business purposes. User shall not license, sublicense, sell, resell, lease, transfer, distribute, time share, or otherwise commercially exploit or make the Essenvia SaaS Platform available to any third party or reverse-engineer, decompile, translate or create derivative works of the Essenvia SaaS Platform in any manner. All ownership rights, title, and interest in and to the Essenvia SaaS Platform, as such may be modified, upgraded, and/or enhanced from time to time (together with all intellectual property rights therein) will remain with and belong exclusively to Essenvia. Essenvia reserves all right, title and interest in and to the Essenvia SaaS Platform not expressly granted to User herein.

Essenvia requires that each User accessing the Platform set up an administrator account. User may specify one or more persons who administer(s) the services and access to the Essenvia SaaS Platform on the User’s behalf (“Administrator(s)”). Administrators have the right to access and to administer individual accounts for users. Additionally, Administrators have the right to view every project created by any of the individuals whose accounts they administer and all projects that such users are invited to. Administrators may also edit login credentials for the accounts they administer, including logging into the Essenvia SaaS Platform or its applications under such accounts or removing such accounts. Administrators are responsible for: (a) maintaining the confidentiality of the password and the Administrator’s account; (b) designating those individuals who are authorized to be Administrators and access the Administrator account(s); and (c) ensuring that all activities that occur in connection with the Administrator account(s) comply with the Terms. User agrees that Essenvia’s responsibilities do not extend to the internal management or administration of any services provided on the Essenvia SaaS Platform.

2.1 Access to Essenvia SaaS Platform. Subject to the terms and conditions of this Agreement, Essenvia hereby grants User a non-exclusive right to access and use the Essenvia SaaS Platform for its internal business purposes. User shall not license, sublicense, sell, resell, lease, transfer, distribute, time share, or otherwise commercially exploit or make the Essenvia SaaS Platform available to any third party or reverse-engineer, decompile, translate or create derivative works of the Essenvia SaaS Platform in any manner. All ownership rights, title, and interest in and to the Essenvia SaaS Platform, as such may be modified, upgraded, and/or enhanced from time to time (together with all intellectual property rights therein) will remain with and belong exclusively to Essenvia. Essenvia reserves all right, title and interest in and to the Essenvia SaaS Platform not expressly granted to User herein.

Essenvia requires that each User accessing the Platform set up an administrator account. User may specify one or more persons who administer(s) the services and access to the Essenvia SaaS Platform on the User’s behalf (“Administrator(s)”). Administrators have the right to access and to administer individual accounts for users. Additionally, Administrators have the right to view every project created by any of the individuals whose accounts they administer and all projects that such users are invited to. Administrators may also edit login credentials for the accounts they administer, including logging into the Essenvia SaaS Platform or its applications under such accounts or removing such accounts. Administrators are responsible for: (a) maintaining the confidentiality of the password and the Administrator’s account; (b) designating those individuals who are authorized to be Administrators and access the Administrator account(s); and (c) ensuring that all activities that occur in connection with the Administrator account(s) comply with the Terms. User agrees that Essenvia’s responsibilities do not extend to the internal management or administration of any services provided on the Essenvia SaaS Platform.

2.2 User Responsibilities. (a) User agrees to abide by all laws, rules, and regulations that are applicable to it and its use of the Essenvia SaaS Platform and shall use the Essenvia SaaS Platform solely for its legitimate business purposes as contemplated by this Agreement and shall not interfere with or disrupt the integrity or performance of the Essenvia SaaS Platform or the data contained therein or attempt to gain unauthorized access to the Essenvia SaaS Platform or its related systems or networks.(b) User shall not include in any User Content any content that is obscene, defamatory, illegal, deceptive, gambling-related, or hateful.(c) User acknowledges and agrees that User is solely responsible for User’s Content and for User’s conduct while using the Essenvia SaaS Platform. By creating, submitting, posting, developing or otherwise making Content available to Essenvia and/or others, User acknowledges and agrees that: (i) User will evaluate and bear all risks associated with User’s Content; (ii) under no circumstances will Essenvia be liable in any way for User’s Content, including, but not limited to, any loss or damage, any errors or omissions, or any unauthorized access or use; and (iii) User (and not Essenvia) is responsible for backing up and protecting the security and confidentiality of User’s Content. While Essenvia implements and maintains physical, technical and administrative security measures designed to protect User Content from unauthorized access, destruction, use, modification, or disclosure and to comply with 21 CFR Part 11 requirements for security, there can be no guaranty that such measures ultimately will prevent unauthorized access by third parties, and therefore User is encouraged to maintain copies of User Content on User’s own computer or local network and to use the latest encryption and other security technology to protect User’s Content.

2.3 Data. As between the parties, User shall own the data it submits via the Essenvia SaaS Platform and the data generated therefrom that is provided by Essenvia to User (the “Data”), except that Essenvia may:(i) copy, use, modify, distribute, display and disclose Data solely to the extent necessary to provide the Essenvia SaaS Platform to User pursuant to the terms and conditions of this Agreement (including, without limitation, for purposes of troubleshooting and problem resolution);(ii) copy, modify and use Data in connection with its business operations and functions, including, but not limited to, operational analytics and reporting, internal financial reporting and analysis, audit functions, and archival purposes; and(iii) copy, modify and use Data on an aggregate and de-identified basis, stripped of any personally identifiable information, for marketing purposes and internal business purposes and analytics, provided that such use or disclosure does not identify User or User’s products, services, segments, attributes, or search criteria, or consist of data solely attributable to User.

2.4 Feedback. User may from time to time provide suggestions, comments for enhancements or functionality or other feedback (“Feedback”) to Essenvia with respect to the Essenvia SaaS Platform. Essenvia shall have full discretion to determine whether or not to proceed with the development of the requested enhancements, new features or functionality. User hereby grants Essenvia a royalty-free, fully paid up, worldwide, transferable, sublicensable, irrevocable, perpetual license to(a) copy, distribute, transmit, display, perform, and create derivative works of the Feedback; and(b) use the Feedback and/or any subject matter thereof, including without limitation, the right to develop, manufacture, have manufactured, market, promote, sell, have sold, offer for sale, have offered for sale, import, have imported, rent, provide and/or lease products or services which practice or embody or are configured for use in practicing, the Feedback and/or any subject matter of the Feedback.

2.5 Access to User Content. User acknowledges and agrees that:(a) Any individual user of the Essenvia SaaS Platform who is designated as a “Company Administrator” can create a project and name any user, including the Company Administrator, as Project Administrator. Company Administrators can invite additional companies and users to their projects. Company Administrators can also grant Company Administrator status to other users. Therefore there may be multiple Company Administrators for a single project. Each project created shall require the payment to Essenvia of the applicable subscription fee.(b) The Company Administrator can, at any time, remove any account it administers from any project, which terminates the ability of the account’s individual user to create new content in such project or see any User Content added to such project.(c) A Project Administrator can, with respect to projects under such Project Administrator’s authority, at any time, (i) modify such project’s settings, (ii) remove any individual user from any company from such project, which terminates such user’s ability to create or view User Content for such project, and (iii) remove any company, and therefore all of the individual users at such company, from such project, which terminates all such users’ ability to create or view User Content for such project.