Core Data Sheets definition

Core Data Sheets means a document prepared by the Regulatory Approval holder containing, in addition to the Company Core Safety Information (CCSI), material relating to the indications, dosing, pharmacokinetics, and other information on the Product for use in the Field in the Territory based on scientific data that are positioned on appropriate prescribing information for safe and effective use of the Product in the Field in the Territory.

Examples of Core Data Sheets in a sentence

  • Prior to submission of any written response submitted to any applicable Regulatory Authority, SPA will have an opportunity to review any portion of the response regarding written alleged violations or deficiencies relating to the Licensed Product.5.2 Product Labels and Inserts; Core Data Sheets.

  • Post-marketing Sources Core Data Sheets and Product Information Updates to the Core Data Sheets (CDS) will be undertaken in collaboration between the Parties who agree to provide all necessary assistance and data required to update the CDSs in the required timeframe.

  • Each Party and its Affiliates shall own and be responsible for all Core Data Sheets for all Licensed Products in its Territory.5.3 Adverse Event Reports.

Related to Core Data Sheets

  • Data Sheet means an integral part of the Instructions to Consultants (ITC) Section 2 that is used to reflect specific country and assignment conditions to supplement, but not to over-write, the provisions of the ITC.

  • Safety Data Sheet means a safety data sheet within the meaning of regulation 5 of the CHIP Regulations;

  • Material safety data sheet or "MSDS" means the chemical, physical, technical, and safety information document supplied by the manufacturer of the coating, solvent, or other chemical product, usually through the distribution network or retailers.

  • Summary data means statistical records and reports derived from data on individuals but in which individuals are not identified and from which neither their identities nor any other characteristic that could uniquely identify the individual is ascertainable.

  • Data Site means an electronic password protected data site maintained by the Borrower (or by the Collateral Manager on behalf of Borrower) at Xxxxxxx Corporation, Intralinks, SyndTrak Online or any other similar electronic distribution system reasonably acceptable to the Administrative Agent.

  • Information processing system means an electronic system for creating, generating, sending, receiving, storing, displaying, or processing information.

  • Data Source Annual Fiscal Audit Report, Terms of Debt, Other Formal Notifications Received by School. Default Rubric Exceeds Standard The school has met standard for at least 3 consecutive years. Meets Standard The school is not in default of any financial obligations, and did not experience any instances of default during the fiscal year. Financial obligations include, but are not limited to, making payments to vendors and utility services on time, complying with all loan covenants, filing any reports required for maintenance of grants or philanthropic funds, meeting all tax obligations, and operating without financial judgements or property liens. Approaches Standard The school experienced one or more instances of minor default during the fiscal year (such as making late payments); however, the school is not currently in default of any financial obligations. Does Not Meet Standard School is currently in default of financial obligations.

  • Billing information means any data that enables any person to access a customer’s or donor’s account, such as a credit card, checking, savings, share or similar account, utility bill, mort- gage loan account, or debit card.

  • Benchmarking Information means information generated by Portfolio Manager, as herein defined including descriptive information about the physical building and its operational characteristics.

  • Customer Proprietary Network Information (“CPNI”) is as defined in the Act.

  • Appendix Information means the information which must be provided for the selected modules as set out in the Appendix of the Approved EU SCCs (other than the Parties), and which for this Addendum is set out in:

  • Data Room Information means the information and documents listed in the index of documents contained in the Data Site attached to the Company Disclosure Letter;

  • Line Information Data Base (LIDB) means a transaction-oriented database system that functions as a centralized repository for data storage and retrieval. LIDB is accessible through CCS networks. LIDB contains records associated with End User line numbers and special billing numbers. LIDB accepts queries from other network elements and provides return result, return error, and return reject responses as appropriate. Examples of information that Account Owners might store in LIDB and in their Line Records are: ABS Validation Data, Originating Line Number Screening (OLNS) data, ZIP Code data, and Calling Name Information.

  • Carrier Access Billing System (“CABS”) is the system which is defined in a document prepared under the direction of the Billing Committee of the OBF. The CABS document is published by Telcordia in Volumes 1, 1A, 2, 3, 3A, 4 and 5 as Special Reports SR-OPT-001868, SR-OPT-0011869, SR-OPT-001871, SR-OPT- 001872, SR-OPT-001873, SR-OPT-001874, and SR-OPT-001875, respectively, and contains the recommended guidelines for the billing of access and other connectivity services. Sprint’s carrier access billing system is its Carrier Access Support System (CASS). CASS mirrors the requirements of CABS.

  • Staffing Information in relation to all persons identified on the Supplier's Provisional Supplier Personnel List or Supplier's Final Supplier Personnel List, as the case may be, such information as the Department may reasonably request (subject to all applicable provisions of the DPA), but including in an anonymised format: (a) their ages, dates of commencement of employment or engagement, gender and place of work; (b) details of whether they are employed, self employed contractors or consultants, agency workers or otherwise; (c) the identity of the employer or relevant contracting Party; (d) their relevant contractual notice periods and any other terms relating to termination of employment, including redundancy procedures, and redundancy payments; (e) their wages, salaries, bonuses and profit sharing arrangements as applicable; (f) details of other employment-related benefits, including (without limitation) medical insurance, life assurance, pension or other retirement benefit schemes, share option schemes and company car schedules applicable to them; (g) any outstanding or potential contractual, statutory or other liabilities in respect of such individuals (including in respect of personal injury claims); (h) details of any such individuals on long term sickness absence, parental leave, maternity leave or other authorised long term absence; (i) copies of all relevant documents and materials relating to such information, including copies of relevant Agreements of employment (or relevant standard Agreements if applied generally in respect of such employees); and (j) any other “employee liability information” as such term is defined in regulation 11 of the Employment Regulations;

  • Vital records means certificates or reports of birth, death, fetal death, marriage, dissolution, annulment, and related data.

  • Protocols means written directions and orders, consistent with the department’s standard of care, that are to be followed by an emergency medical care provider in emergency and nonemergency situations. Protocols must be approved by the service program’s medical director and address the care of both adult and pediatric patients.

  • Health record means the same as that term is defined in § 32.1-127.1:03.

  • data user means a natural or legal person who has lawful access to certain personal or non-personal data and is authorised to use that data for commercial or non-commercial purposes;

  • TDP means “TDP” as that term is defined in the Second Amended Joint Plan or as that term is defined in any Plan confirmed by the Bankruptcy Court.

  • Project Record means the separate set of Drawings and Specifications as further set forth in paragraph 4.02A.

  • Project Results means all data and results of the Project.

  • Contractor information system means an information system belonging to, or operated by or for, the Contractor.

  • Basic Comprehensive User Guide means the Ministry document titled Basic Comprehensive Certificates of Approval (Air) User Guide” dated April 2004 as amended.

  • System Data means data and data elements collected by the SaaS Software, SaaS Service or Licensor’s computer systems regarding configuration, environment, usage, performance, vulnerabilities and security of the SaaS Software or SaaS Service that may be used to generate logs, statistics and reports regarding performance, availability, integrity and security of the SaaS Software.