Safety Data Exchange (SDE) Agreements Sample Clauses

Safety Data Exchange (SDE) Agreements. No later than [*] after the Effective Date, the Parties will enter into one or more written agreements setting forth safety and pharmacovigilance procedures for the Parties with respect to the Licensed Products in the Field in the Territory (a “SDE Agreement”). Partner will not market, promote, sell, or otherwise Commercialize any Licensed Product unless and until the Parties enter into one or more SDE Agreements for the Licensed Product. Each SDE Agreement will describe the obligations of both Parties with respect to the collection, investigation, reporting, and exchange of information between the Parties concerning any adverse event experienced by a subject or patient, and the seriousness thereof, whether or not determined to be attributable to a Licensed Product, including any such information received by either Party from a Third Party (subject to receipt of any required consents from such Third Party) ​ ​ and will be sufficient to permit each Party and its Affiliates, licensees, or Sublicensees (as applicable) to comply with its legal obligations with respect thereto, including each Party’s obligations as the owner or holder of Regulatory Approvals and Regulatory Submissions (including INDs) for such Licensed Product in the Territory, as applicable. Each SDE Agreement will also detail (a) each Party’s responsibilities with respect to the maintenance of a safety database, (b) the other Party’s rights to access and query such database, it being understood that (x) each Party can run safety data queries for the other Party, provided that such safety data queries are limited to (i) safety questions on the vector from Regulatory Authorities in order to respond to ad hoc queries from Regulatory Authorities, and (ii) four queries per Party per year, and further provided that the Parties must reach an agreement regarding any interpretations and conclusions to be submitted to the Regulatory Authorities, and (y) uniQure will maintain the global safety database for the Licensed Products until the primary and secondary endpoints have been reached (which is estimated to be [*]), at which time uniQure will transition to Partner such global safety database and thereafter Partner will run the safety data queries described in clause (x) in such global safety database on reasonable notice at uniQure’s request up to four times per year, provided that the queries will be limited to safety questions on the vector from Regulatory Authorities in order to respond to ad hoc q...
Sample 1

Related to Safety Data Exchange (SDE) Agreements

  • Safety Data Sheets If specified by City in the solicitation or otherwise required by this Contract, Contractor must send with each shipment one (1) copy of the Safety Data Sheet (SDS) for each item shipped. Failure to comply with this procedure will be cause for immediate termination of the Contract for violation of safety procedures.

  • MATERIAL SAFETY DATA SHEETS As applicable, Contractor shall provide Purchaser with all appropriate Material Safety Data Sheets (“MSDS”) at the time of delivery of each shipment of Goods which requires such compliance and/or and for materials used by Contractor while performing Services and any updates of the same.

  • Material Safety Data Sheet Seller shall provide to Buyer with each delivery any Material Safety Data Sheet applicable to the work in conformance with and containing such information as required by the Occupational Safety and Health Act of 1970 and regulations promulgated thereunder or its State approved counterpart.

  • Statistical Sampling Documentation a. A copy of the printout of the random numbers generated by the “Random Numbers” function of the statistical sampling software used by the IRO.‌ b. A description or identification of the statistical sampling software package used by the IRO.‌

  • Compliance with Texas Privacy Laws and Regulations In performing their respective obligations under the Agreement, the LEA and the Provider shall comply with all Texas laws and regulations pertaining to LEA data privacy and confidentiality, including but not limited to the Texas Education Code Chapter 32, and Texas Government Code Chapter 560.

  • Disturbance Analysis Data Exchange The Parties will cooperate with one another and the NYISO in the analysis of disturbances to either the Large Generating Facility or the New York State Transmission System by gathering and providing access to any information relating to any disturbance, including information from disturbance recording equipment, protective relay targets, breaker operations and sequence of events records, and any disturbance information required by Good Utility Practice.

  • Proposed Policies and Procedures Regarding New Online Content and Functionality By October 31, 2017, the School will submit to OCR for its review and approval proposed policies and procedures (“the Plan for New Content”) to ensure that all new, newly-added, or modified online content and functionality will be accessible to people with disabilities as measured by conformance to the Benchmarks for Measuring Accessibility set forth above, except where doing so would impose a fundamental alteration or undue burden. a) When fundamental alteration or undue burden defenses apply, the Plan for New Content will require the School to provide equally effective alternative access. The Plan for New Content will require the School, in providing equally effective alternate access, to take any actions that do not result in a fundamental alteration or undue financial and administrative burdens, but nevertheless ensure that, to the maximum extent possible, individuals with disabilities receive the same benefits or services as their nondisabled peers. To provide equally effective alternate access, alternates are not required to produce the identical result or level of achievement for persons with and without disabilities, but must afford persons with disabilities equal opportunity to obtain the same result, to gain the same benefit, or to reach the same level of achievement, in the most integrated setting appropriate to the person’s needs. b) The Plan for New Content must include sufficient quality assurance procedures, backed by adequate personnel and financial resources, for full implementation. This provision also applies to the School’s online content and functionality developed by, maintained by, or offered through a third-party vendor or by using open sources. c) Within thirty (30) days of receiving OCR’s approval of the Plan for New Content, the School will officially adopt, and fully implement the amended policies and procedures.

  • Tax Documentation For the purposes of Sections 4(a)(i) and 4(a)(ii) of the Agreement, Counterparty shall provide to Dealer a valid and duly executed U.S. Internal Revenue Service Form W-9, or any successor thereto, completed accurately and in a manner reasonably acceptable to Dealer and, in particular, with the “corporation” box checked on line 3 thereof (i) on or before the date of execution of this Confirmation; (ii) promptly upon reasonable demand by Dealer; and (iii) promptly upon learning that any such tax form previously provided by Counterparty has become inaccurate or incorrect. Additionally, Counterparty shall, promptly upon reasonable request by Dealer, provide, such other tax forms and documents, accurately completed and in a manner reasonably acceptable to Dealer, that may be required or reasonably requested to allow Dealer to make a payment under this Confirmation, including any Credit Support Document, without any deduction or withholding for or on account of any Tax or with such deduction at a reduced rate. For the purposes of Sections 4(a)(i) and 4(a)(ii) of the Agreement, Dealer shall provide to Counterparty a valid and duly executed U.S. Internal Revenue Service Form W-9 or W-8ECI, or any successor thereto, completed accurately and in a manner reasonably acceptable to Counterparty and, in particular, with the “corporation” box checked on line 3 or 4 thereof, (i) on or before the date of execution of this Confirmation; (ii) promptly upon reasonable demand by Counterparty; and (iii) promptly upon learning that any such tax form previously provided by Dealer has become inaccurate or incorrect. Additionally, Dealer shall, promptly upon reasonable request by Counterparty, provide such other tax forms and documents, accurately completed and in a manner reasonably acceptable to Counterparty, that may be required or reasonably requested to allow Counterparty to make a payment under this Confirmation, including any Credit Support Document, without any deduction or withholding for or on account of any Tax or with such deduction at a reduced rate.

  • New Hampshire Specific Data Security Requirements The Provider agrees to the following privacy and security standards from “the Minimum Standards for Privacy and Security of Student and Employee Data” from the New Hampshire Department of Education. Specifically, the Provider agrees to: (1) Limit system access to the types of transactions and functions that authorized users, such as students, parents, and LEA are permitted to execute; (2) Limit unsuccessful logon attempts; (3) Employ cryptographic mechanisms to protect the confidentiality of remote access sessions; (4) Authorize wireless access prior to allowing such connections; (5) Create and retain system audit logs and records to the extent needed to enable the monitoring, analysis, investigation, and reporting of unlawful or unauthorized system activity; (6) Ensure that the actions of individual system users can be uniquely traced to those users so they can be held accountable for their actions; (7) Establish and maintain baseline configurations and inventories of organizational systems (including hardware, software, firmware, and documentation) throughout the respective system development life cycles; (8) Restrict, disable, or prevent the use of nonessential programs, functions, ports, protocols, and services; (9) Enforce a minimum password complexity and change of characters when new passwords are created; (10) Perform maintenance on organizational systems; (11) Provide controls on the tools, techniques, mechanisms, and personnel used to conduct system maintenance; (12) Ensure equipment removed for off-site maintenance is sanitized of any Student Data in accordance with NIST SP 800-88 Revision 1; (13) Protect (i.e., physically control and securely store) system media containing Student Data, both paper and digital; (14) Sanitize or destroy system media containing Student Data in accordance with NIST SP 800-88 Revision 1 before disposal or release for reuse; (15) Control access to media containing Student Data and maintain accountability for media during transport outside of controlled areas; (16) Periodically assess the security controls in organizational systems to determine if the controls are effective in their application and develop and implement plans of action designed to correct deficiencies and reduce or eliminate vulnerabilities in organizational systems; (17) Monitor, control, and protect communications (i.e., information transmitted or received by organizational systems) at the external boundaries and key internal boundaries of organizational systems; (18) Deny network communications traffic by default and allow network communications traffic by exception (i.e., deny all, permit by exception); (19) Protect the confidentiality of Student Data at rest; (20) Identify, report, and correct system flaws in a timely manner; (21) Provide protection from malicious code (i.e. Antivirus and Antimalware) at designated locations within organizational systems; (22) Monitor system security alerts and advisories and take action in response; and (23) Update malicious code protection mechanisms when new releases are available.

  • CERTIFICATION REGARDING CERTAIN FOREIGN-OWNED COMPANIES IN CONNECTION WITH CRITICAL INFRASTRUCTURE (Texas law as of September 1, 2021) By submitting a proposal to this Solicitation, you certify that you agree to the following required by Texas law as of September 1, 2021: Proposing Company is prohibited from entering into a contract or other agreement relating to critical infrastructure that would grant to the company direct or remote access to or control of critical infrastructure in this state, excluding access specifically allowed by the Proposing Company for product warranty and support purposes. Company, certifies that neither it nor its parent company nor any affiliate of company or its parent company, is (1) owned by or the majority of stock or other ownership interest of the company is held or controlled by individuals who are citizens of China, Iran, North Korea, Russia, or a designated country; (2) a company or other entity, including governmental entity, that is owned or controlled by citizens of or is directly controlled by the government of China, Iran, North Korea, Russia, or a designated country; or (3) headquartered in China, Iran, North Korea, Russia, or a designated country. For purposes of this contract, “critical infrastructure” means “a communication infrastructure system, cybersecurity system, electric grid, hazardous waste treatment system, or water treatment facility.” See Tex. Gov’t Code § 2274.0101(2) of SB 1226 (87th leg.). The company verifies and certifies that company will not grant direct or remote access to or control of critical infrastructure, except for product warranty and support purposes, to prohibited individuals, companies, or entities, including governmental entities, owned, controlled, or headquartered in China, Iran, North Korea, Russia, or a designated country, as determined by the Governor.