ASPEN PLATFORM AGREEMENT
1.1 “Affiliates” means, with respect to either Party, any entity that, directly or indirectly, controls, is under common control with, or is controlled by, such entity. For this purpose, “control” means, with respect to (i) a corporation, the right to exercise, directly or indirectly, more than fifty percent (50%) of the voting rights attributable to the shares of such corporation, and (ii) with respect to any person other than a corporation, the possession, directly or indirectly, of the power to direct or cause the direction of the management or policies of such person, whether through ownership of securities or partnership or other interests, by contract or otherwise.
1.4 “Authorized Site” means a Site, insofar as it has been designated by a Provider on the Aspen Platform as being authorized to use the Aspen Platform for the Site Permitted Purpose.
1.5 “Authorized User” means either a Provider Authorized User or a Site Authorized User, based on whether Company is a Provider or a Site.
1.6 “Candidate Identification Analysis” means identifying, from De-Identified Data Sets of certain patient Clinical Data, potential candidates matching certain criteria set forth for participation in a clinical study in connection with the Research.
1.7 “Clinical Data” means clinical data related to patients of a Provider that is contained in the Medical Record Data.
1.8 “De-Identified Data Set” means a data set containing Clinical Data that has been de-identified.
1.9 “HIPAA” means the Health Insurance Portability and Accountability Act of 1996 and the Health Information Technology for Economic and Clinical Health Act provisions of the American Recovery and Reinvestment Act of 2009, Pub. Law No. 111-5, and their implementing regulations; in each case as amended from time to time.
1.10 “Intellectual Property Rights” means all intellectual property and proprietary rights pursuant to the laws of any jurisdiction throughout the world, including any and all rights in, to, and under patents, copyrights, works, trade secrets, know-how, trademarks, trade names, software, data, confidential information, databases, designs and models; in each case including (but not limited to) registrations of, applications for, and all goodwill associated with, any of the foregoing.
1.11 “Medical Record Data” means any data (including Clinical Data) that a Provider maintains in its medical records and makes available to the Aspen Platform for the Site Permitted Purpose.
1.12 “Permitted Purpose” means either the Provider Permitted Purpose or the Site Permitted Purpose, based on whether Company is a Provider or a Site.
1.14 “Provider” means a healthcare provider that has made available certain Medical Record Data to the Aspen Platform pursuant to a Platform Agreement.
1.16 “Provider Permitted Purpose” means to review, contact, and/or designate Site to contact, potential candidates identified under the Candidate Identification Analysis depending on the candidate contact option selected by Provider in the Provider Access Form.
1.17 “Research” means certain medical research conducted or anticipated to be conducted by a Site.
1.18 “Research Agreement” means an agreement between a Provider and a Site under which Provider agrees to support the performance of the Research being conducted by a Site.
1.19 “Services” means the Aspen Platform and any Support Services and Training Services selected in an applicable Site Order Form.
1.20 “Site” means a research site that is conducting certain Research and seeks to access and use the Aspen Platform pursuant to a Platform Agreement.
1.22 “Site Permitted Purpose” means, insofar as a Site has been designated as being an Authorized Site by a Provider, to (i) perform the Candidate Identification Analysis, and (ii) view or receive certain limited information sufficient to contact and recruit potential candidates identified as a result of the Candidate Identification Analysis as authorized by Provider’s privacy review board. For the avoidance of doubt, the Site Permitted Purpose is limited to (i) viewing or receiving only that certain limited contact information made available to the Aspen Platform by or on behalf of the Provider that designated the corresponding Site as being an Authorized Site, and (ii) using that certain limited contact information for such recruiting purposes only in connection with the specific Research designated by the Provider that designated the corresponding Site as being an Authorized Site.
1.23 “Usage Data” means performance data, statistics, and other information related to the use of the Aspen Platform by all users.
2. SCOPE OF SERVICES.
2.1 Aspen Platform. During the Term, and subject to the terms and conditions of this Agreement, Aspen will provide Company and its Authorized Users access to use the Aspen Platform as described in the applicable Documentation provided by Aspen in accordance with the terms and conditions set forth in this Agreement.
2.2 Support Services. During the Term, and subject to the terms and conditions of this Agreement, Aspen will provide to Company the support services selected in the Site Order Form and further described in Schedule A of the Site Order Form (“Support Services”) in accordance with the terms and conditions set forth in this Agreement.
2.3 Training Services. During the Term, and subject to the terms and conditions of this Agreement, Aspen will provide to Company the training services selected in the Site Order Form and further described in Schedule B of the Site Order Form (“Training Services”) in accordance with the terms and conditions set forth in this Agreement.
2.4 Candidate Identification Analysis. Site will perform the Candidate Identification Analysis unless Site and Aspen otherwise arrange for Aspen to perform the Candidate Identification Analysis. In the event Site and Aspen arrange for Aspen to perform the Candidate Identification Services, Aspen’s performance of the Candidate Identification Analysis will be governed by a separate services agreement between Site and Aspen. Provider hereby acknowledges and agrees that Site is permitted to engage Aspen to perform the Candidate Identification Services without notice or consent of Provider.
3. FEES AND PAYMENT.
3.1 Service Fees. Site will pay Aspen in the amounts, and at such intervals, for the Services set forth in the Site Order Form (“Fees”) in accordance with the payment terms set forth in the Site Order Form.
4. ACCESS LICENSE GRANT.
4.2 No Affiliate License. The Platform License does not permit Company to sell, license, sublicense, rent, lease, encumber, lend, distribute, transfer, or otherwise provide access to the Aspen Platform in any form to any third party other than its Authorized Users. For the avoidance of any doubt, and without limiting the foregoing, third parties include not only companies and persons unrelated to Company, but also any Affiliate or subsidiary of Company. Notwithstanding the foregoing, Aspen may, in its sole discretion, permit use of the Aspen Platform by an Affiliate or subsidiary of Company, but in each such case, Affiliates and subsidiaries will be required to execute a separate Platform Agreement with Aspen and may be required to pay additional fees.
5. ACCESS AND USE RESTRICTIONS.
5.3 Provider Restrictions. Notwithstanding any features and functionality available under the Aspen Platform that may be used to the contrary, Provider shall not use or attempt to use the Aspen Platform:
(a) For any purpose whatsoever other than the Provider Permitted Purpose; and
(b) In any way that violates or breaches the terms and conditions of an applicable Research Agreement between Provider and a Site.
5.4 Site Restrictions. Notwithstanding any features and functionality available under the Aspen Platform that may be used to the contrary, Site shall not use or attempt to use the Aspen Platform:
(a) For any purpose whatsoever other than the Site Permitted Purpose;
(b) To access or use any data of any Provider who has not designated Site as an Authorized Site in connection with accessing and using such Provider’s data;
(c) To access or use any data of a Provider who has designated Site as an Authorized Site other than in connection with the specific Research designated by such Provider; and
(d) In any way that violates or breaches the terms and conditions of the applicable Research Agreement between Site and a Provider.
5.5 Other Restrictions. Company shall not (and shall not allow any third party to): (i) gain or attempt to gain unauthorized access to the Aspen platform, or any element thereof, or circumvent or otherwise interfere with any authentication or security measures of the Aspen Platform; (ii) interfere with or disrupt the integrity or performance of the Aspen Platform; (iii) transmit material containing software viruses or other harmful or deleterious computer code, files, scripts, agents, or programs; (iv) decompile, disassemble, scan, reverse engineer or attempt to discover any source code or underlying ideas or algorithms of any Aspen Platform (except to the extent that applicable law expressly prohibits such a reverse engineering restriction); (v) provide, lease, lend, use for timesharing or service bureau purposes, or otherwise use or allow others to use the Aspen Platform for the benefit of any third party; (vi) list or otherwise display or copy any code of any Aspen Platform; (vii) copy any Aspen Platform (or component thereof) or develop any improvement, modification, or derivative work thereof; (viii) include any portion of any Aspen Platform in any other service, equipment, or item; (ix) allow the transfer, transmission (including without limitation making available on-line, electronically transmitting, or otherwise communicating, to the public), export, or re-export of any Aspen Platform (or any portion thereof) or any Aspen technical data; (x) perform benchmark tests on the Aspen Platform or (xi) use, evaluate, or view the Aspen Platform for the purpose of designing, modifying, or otherwise creating any environment, software, models, algorithms, products, program, or infrastructure or any portion thereof, which performs functions similar to the functions performed by the Aspen Platform; provided further that Company will not attempt to, or encourage any third party to, sell, rent, lease, license, sublicense, distribute, transfer, or syndicate such software, without prior written approval from Aspen.
6. SUSPENSION AND ACCOUNT TERMINATION.
6.2 Ongoing Harm. Aspen reserves the right to suspend and/or terminate Company’s access to and/or use of the Aspen Platform if Aspen believes in good faith that such termination or suspension is necessary to preserve the security, integrity, or accessibility of the Aspen Platform, or to prevent the Aspen Platform from being used to engage in denial of service attacks, spamming, illegal activity, or other activities causing immediate, material, and ongoing harm to Aspen or others. In the extraordinary event that Aspen suspends access to the Aspen Platform for such reasons, Aspen will use commercially reasonable efforts to limit the suspension to the offending portion of the Aspen Platform and resolve the issues causing the suspension of the Aspen Platform.
6.3 Bankruptcy or Cessation of Business. Aspen reserves the right to suspend and/or terminate access to and/or use of the Aspen Platform, subject to applicable law, if Company has ceased to continue its business in the ordinary course, made an assignment for the benefit of creditors or similar disposition of its assets, or becomes the subject of any bankruptcy, reorganization, liquidation, dissolution, or similar proceeding.
6.4 Termination of Third-Party Licenses. Aspen reserves the right to suspend and/or terminate Company’s access to and/or use of the Aspen Platform if any vendor or licensor of Aspen has suspended or terminated Aspen’s access to or use of any third-party services or products required to enable Company to access and use the Aspen Platform.
6.5 No Liability. Company agrees that Aspen shall not be liable to Company or other third party for any suspension of the Aspen Platform pursuant to this Section 6.
7. PROPRIETARY RIGHTS.
7.2 Feedback. Company shall assign, and does hereby assign, to Aspen any and all Intellectual Property Rights associated with any improvements to, additional or modified functionality or features of, and potential industry applications for or relating to the Aspen Platform (collectively, “Feedback”) that Company or its Authorized Users may conceive of, whether in whole or in part. To the extent these rights cannot be assigned by Company to Aspen, Company hereby grants to Aspen a fully paid-up, royalty-free, exclusive, worldwide, irrevocable, transferable, and sublicensable (with rights to sublicense through multiple tiers of sublicensees) license to fully exploit such Feedback without any further accounting to Company or its Authorized Users. To the extent these rights can neither be assigned or licensed, Company hereby waives any and all claims against Aspen and its customers and other parties in its manufacture, supply, distribution, and sales ecosystem in connection with such rights, including any moral rights Company or its Authorized Users may have in such Feedback.
8. MUTUAL CONFIDENTIALITY.
9. REPRESENTATIONS, WARRANTIES, AND COVENANTS.
9.2 Compliance. Company will comply with the terms of any Applicable Law in connection with Company’s use of the Aspen Platform, including the Foreign Corrupt Practices Act, the Federal Food Drug and Cosmetic Act, the Stark Act, the False Claims Act, the Federal Anti-Kickback Statute (and each of their implementing regulations), the Affordable Care Act, and HIPAA.
9.6 Additional Representations, Warranties, and Covenants of Company. Company has and will maintain adequate physical, administrative, and technical safeguards to (a) reasonably ensure that access and use of the Aspen Platform and Medical Record Data is limited to its Authorized Users for the Permitted Purpose, and (b) promptly identify any instances of unauthorized access or use of the Aspen Platform or Medical Record Data by Company or its personnel.
9.7 DISCLAIMER. ASPEN DOES NOT MAKE ANY REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY WARRANTY OF MERCHANTABILITY, NON-INFRINGEMENT, OR FITNESS FOR A PARTICULAR PURPOSE.
12. TERM AND TERMINATION.