Rights of Reference to Regulatory Documentation Sample Clauses

Rights of Reference to Regulatory Documentation. Each Party hereby grants to the other Party a right of reference to all Regulatory Documentation filed by such Party for the Products subject to the scope of the licenses granted hereunder, including, for the avoidance of doubt, all such Regulatory Documentation filed by Ampio for Regulatory Approval of the Products in the Retained Territory and all supplemental filings related thereto, and all “Certificate(s) of Pharmaceutical Product” and/or “Certificate(s) of Free Sales” resulting from Regulatory Approval of such Products, solely for the purpose of seeking, obtaining and maintaining Regulatory Approvals for, and the Commercialization of, the Product in the Territory and the Field, consistent with the roles of the Parties set forth in this Agreement. In addition, Daewoong hereby grants to Ampio a right of reference to all Regulatory Documentation filed by Daewoong in the Territory for the purpose of Ampio, its Affiliates or any Ampio Licensees developing and obtaining and/or maintaining Regulatory Approvals anywhere in the world for the Products in the Field in the Retained Territory.
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Related to Rights of Reference to Regulatory Documentation

  • Regulatory References A reference in this Agreement to a section in the HIPAA Rules means the section as in effect or as amended.

  • Product References a. “Or Equal” In all Solicitations or Bid Specifications, the words “or equal” are understood to apply where a copyrighted, brand name, trade name, catalog reference, or patented Product is referenced. References to such specific Product are intended as descriptive, not restrictive, unless otherwise stated. Comparable Product will be considered if proof of compatibility is provided, including appropriate catalog excerpts, descriptive literature, specifications and test data, etc. The Commissioner’s decision as to acceptance of the Product as equal shall be final. b. Discrepancies in References In the event of a discrepancy between the model number referenced in the Solicitation or Bid Specifications and the written description of the Products that cannot be reconciled, then the written description shall prevail.

  • Right to Receive Documentation a. Periodic Statements. Transfers and withdrawals made through any ATM or POS terminal, debit card transactions, audio response transactions, preauthorized EFTs, online/PC transactions, mobile access device transactions or xxxx payments you make will be recorded on your periodic statement. You will receive a statement monthly unless there is no transaction in a particular month. In any case, you will receive a statement at least quarterly.

  • Bill of Rights for Data Privacy and Security As required by Education Law Section 2-d, the Parents Bill of Rights for Data Privacy and Security and the supplemental information for the Service Agreement are included as Exhibit A and Exhibit B, respectively, and incorporated into this DPA. Contractor shall complete and sign Exhibit B and append it to this DPA. Pursuant to Education Law Section 2-d, the EA is required to post the completed Exhibit B on its website.

  • Reference to and Effect Upon the Credit Agreement (a) The Credit Agreement and the other Loan Documents shall remain in full force and effect, as amended hereby, and are hereby ratified and confirmed. (b) The execution, delivery and effectiveness of this Amendment shall not operate as a waiver of any right, power or remedy of Agent or any Lender under the Credit Agreement or any Loan Document, nor constitute a waiver or amendment of any provision of the Credit Agreement or any Loan Document, except as specifically set forth herein. Upon the effectiveness of this Amendment, each reference in the Credit Agreement to “this Credit Agreement,” “hereunder,” “hereof,” “herein” or words of similar import shall mean and be a reference to the Credit Agreement as amended hereby.

  • 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.

  • Background Screening and Security ‌ All Contractor employees and agents performing work under the Contract must comply with all security and other requirements of the Department.

  • Defined Terms; References Unless otherwise specifically defined herein, each term used herein which is defined in the Credit Agreement has the meaning assigned to such term in the Credit Agreement. Each reference to "hereof", "hereunder", "herein" and "hereby" and each other similar reference and each reference to "this Agreement" and each other similar reference contained in the Credit Agreement shall, after this Amendment becomes effective, refer to the Credit Agreement as amended hereby.

  • Licensed Documentation If commercially available, Licensee shall have the option to require the Contractor to deliver, at Contractor’s expense: (i) one (1) hard copy and one (1) master electronic copy of the Documentation in a mutually agreeable format; (ii) based on hard copy instructions for access by downloading from the Internet

  • General Application The rules set forth below in this Article VI shall apply for the purposes of determining each Member’s allocable share of the items of income, gain, loss and expense of the Company comprising Net Income or Net Loss for each Fiscal Year, determining special allocations of other items of income, gain, loss and expense, and adjusting the balance of each Member’s Capital Account to reflect the aforementioned general and special allocations. For each Fiscal Year, the special allocations in Section 6.03 hereof shall be made immediately prior to the general allocations of Section 6.02 hereof.

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