Special Reports and Services (i) Ultimus may provide additional special reports upon the request of the Trust or a Portfolio's investment adviser, which may result in an additional charge, the amount of which shall be agreed upon between the parties.
(ii) Ultimus may provide such other similar services with respect to a Portfolio as may be reasonably requested by the Trust, which may result in an additional charge, the amount of which shall be agreed upon between the parties.
Public Posting of Approved Users’ Research Use Statement The PI agrees that information about themselves and the approved research use will be posted publicly on the dbGaP website. The information includes the PI’s name and Requester, project name, Research Use Statement, and a Non-Technical Summary of the Research Use Statement. In addition, and if applicable, this information may include the Cloud Computing Use Statement and name of the CSP or PCS. Citations of publications resulting from the use of controlled-access datasets obtained through this DAR may also be posted on the dbGaP website.
Handling Sensitive Personal Information and Breach Notification A. As part of its contract with HHSC Contractor may receive or create sensitive personal information, as section 521.002 of the Business and Commerce Code defines that phrase. Contractor must use appropriate safeguards to protect this sensitive personal information. These safeguards must include maintaining the sensitive personal information in a form that is unusable, unreadable, or indecipherable to unauthorized persons. Contractor may consult the “Guidance to Render Unsecured Protected Health Information Unusable, Unreadable, or Indecipherable to Unauthorized Individuals” issued by the U.S. Department of Health and Human Services to determine ways to meet this standard.
B. Contractor must notify HHSC of any confirmed or suspected unauthorized acquisition, access, use or disclosure of sensitive personal information related to this Contract, including any breach of system security, as section 521.053 of the Business and Commerce Code defines that phrase. Contractor must submit a written report to HHSC as soon as possible but no later than 10 business days after discovering the unauthorized acquisition, access, use or disclosure. The written report must identify everyone whose sensitive personal information has been or is reasonably believed to have been compromised.
C. Contractor must either disclose the unauthorized acquisition, access, use or disclosure to everyone whose sensitive personal information has been or is reasonably believed to have been compromised or pay the expenses associated with HHSC doing the disclosure if:
1. Contractor experiences a breach of system security involving information owned by HHSC for which disclosure or notification is required under section 521.053 of the Business and Commerce Code; or
2. Contractor experiences a breach of unsecured protected health information, as 45 C.F.R. §164.402 defines that phrase, and HHSC becomes responsible for doing the notification required by 45 C.F.R. §164.404. HHSC may, at its discretion, waive Contractor's payment of expenses associated with HHSC doing the disclosure.
Diversity Reporting Upon request, the Contractor will report to the Department its spend with business enterprises certified by the OSD. These reports must include the time period covered, the name and Federal Employer Identification Number of each business enterprise utilized during the period, commodities and contractual services provided by the business enterprise, and the amount paid to the business enterprise on behalf of each agency purchasing under the Contract.
Diversity Report The Contractor shall report to each Customer, spend with certified and other minority business enterprises. These reports shall include the period covered, the name, minority code and Federal Employer Identification Number of each minority business utilized during the period, Commodities provided by the minority business enterprise, and the amount paid to each minority business on behalf of each purchasing agency ordering under the terms of this Contract.
Requester and Approved User Responsibilities The Requester agrees through the submission of the DAR that the PI named has reviewed and understands the principles for responsible research use and data management of the genomic datasets as defined in the NIH Security Best Practices for Controlled-Access Data Subject to the GDS Policy. The Requester and Approved Users further acknowledge that they are responsible for ensuring that all uses of the data are consistent with national, tribal, and state laws and regulations, as appropriate, as well as relevant institutional policies and procedures for managing sensitive genomic and phenotypic data. The Requester certifies that the PI is in good standing (i.e., no known sanctions) with the institution, relevant funding agencies, and regulatory agencies and is eligible to conduct independent research (i.e., is not a postdoctoral fellow, student, or trainee). The Requester and any Approved Users may use the dataset(s) only in accordance with the parameters described on the study page and in the 1 If contractor services are to be utilized, PI requesting the data must provide a brief description of the services that the contractor will perform for the PI (e.g., data cleaning services) in the research use statement of the DAR. Additionally, the Key Personnel section of the DAR must include the name of the contractor’s employee(s) who will conduct the work. These requirements apply whether the contractor carries out the work at the PI’s facility or at the contractor’s facility. In addition, the PI is expected to include in any contract agreement requirements to ensure that any of the contractor’s employees who have access to the data adhere to the NIH GDS Policy, this Data Use Certification Agreement, and the NIH Security Best Practices for Controlled-Access Data Subject to the GDS Policy. Note that any scientific collaborators, including contractors, who are not at the Requester must submit their own DAR. Addendum to this Agreement for the appropriate research use, as well as any limitations on such use, of the dataset(s), as described in the DAR, and as required by law. Through the submission of this DAR, the Requester and Approved Users acknowledge receiving and reviewing a copy of the Addendum which includes Data Use Limitation(s) for each dataset requested. The Requester and Approved Users agree to comply with the terms listed in the Addendum. Through submission of the DAR, the PI and Requester agree to submit a Project Renewal or Project Close-out prior to the expiration date of the one (1) year data access period. The PI also agrees to submit an annual Progress Update prior to the one (1) year anniversary2 of the project, as described under Research Use Reporting (Term 10) below. By approving and submitting the attached DAR, the Institutional Signing Official provides assurance that relevant institutional policies and applicable local, state, tribal, and federal laws and regulations, as applicable, have been followed, including IRB approval, if required. Approved Users may be required to have IRB approval if they have access to personal identifying information for research participants in the original study at their institution, or through their collaborators. The Institutional Signing Official also assures, through the approval of the DAR, that other institutional departments with relevant authorities (e.g., those overseeing human subjects research, information technology, technology transfer) have reviewed the relevant sections of the NIH GDS Policy and the associated procedures and are in agreement with the principles defined. The Requester acknowledges that controlled-access datasets subject to the NIH GDS Policy may be updated to exclude or include additional information. Unless otherwise indicated, all statements herein are presumed to be true and applicable to the access and use of all versions of these datasets.
Introduction and Statement of Policy The National Institutes of Health (NIH) has established NIH-designated data repositories (e.g., database of Genotypes and Phenotypes (dbGaP), Sequence Read Archive (SRA), NIH Established Trusted Partnerships) for securely storing and sharing controlled-access human data submitted to NIH under the NIH Genomic Data Sharing (GDS)
Adverse Event Reporting Both Parties acknowledge the obligation to comply with the Protocol and / or applicable regulations governing the collection and reporting of adverse events of which they may become aware during the course of the Clinical Trial. Both Parties agree to fulfil and ensure that their Agents fulfil regulatory requirements with respect to the reporting of adverse events.
Development Reports Beginning six months after Effective Date and ending on the date of first commercial sale of a Licensed Product in the United States, LICENSEE shall report to Cornell progress covering LICENSEE's (and Affiliate's and Sublicensee's) activities and efforts in the development of rights granted to LICENSEE under this Agreement for the preceding six months. The report shall include, but not be limited to, activities and efforts to develop and test all Licensed Products and obtain governmental approvals necessary for marketing the same. Such semi-annual reports shall be due within sixty days (60) of the reporting period and shall use the form as provided herein as Appendix C.
Patient Information Each Party agrees to abide by all laws, rules, regulations, and orders of all applicable supranational, national, federal, state, provincial, and local governmental entities concerning the confidentiality or protection of patient identifiable information and/or patients’ protected health information, as defined by any other applicable legislation in the course of their performance under this Agreement.