FDA DOCUMENTATION definition

FDA DOCUMENTATION means, with respect to the ADCON Assets, all filings and supporting documents submitted to the FDA relating to such ADCON Assets, and all data contained therein or incorporated therein by reference, including, without limitation, any INDs, BLAs, Master Files, investigator's brochures, correspondence to and from the FDA, written summaries of any oral discussions with the FDA, including without limitation minutes from teleconferences and meetings with the FDA, registrations and licenses, regulatory drug lists, advertising and labeling (including promotional labeling) documents, adverse event files, complaint files and manufacturing records.

Related to FDA DOCUMENTATION

  • Product Documentation means the specific materials listed under “Product Documentation” at xxx.xxxxxx.xxx/xxxxx, as updated by Vocera from time to time.

  • Related Documentation means, with respect to Software, all materials, documentation (including control documentation utilized in connection with an audit), specifications, technical manuals, user manuals, flow diagrams, file descriptions and other written information that describes the function and use of such Software, but excluding source code.

  • User Documentation means that documentation regarding the operation, guidelines and features and functionality of Clover Insights that is made available to you from time to time at the website, by internet link or otherwise. User Documentation may be modified from time to time by First Data or its third party provider(s).

  • Design Documentation means all schematics and test, assembly and package documentation relating to the Product, including all design, specification and assembly documentation and data files for Materials, which is necessary for the production, manufacture, qualification, testing and delivery of the Product to be attached as Exhibit A.

  • Software Documentation means software information, being technical information used, or useful in, or relating to the design, development, use or maintenance of any version of a software programme.

  • Technical Documentation means designs, reports, photographs, drawings, plans, specifications, computer software, surveys, calculations and other data, information and material collected, computed, drawn or produced, including computer print-outs.

  • Supporting Documentation means the documents listed in Schedule A of this Certificate which forms part of this

  • Flood Documentation means, with respect to each Mortgaged Property located in the United States of America or any territory thereof, (i) a completed “life-of-loan” Federal Emergency Management Agency standard flood hazard determination (to the extent a Mortgaged Property is located in a Special Flood Hazard Area, together with a notice about Special Flood Hazard Area status and flood disaster assistance duly executed by the Borrower and the applicable Loan Party relating thereto) and (ii) a copy of, or a certificate as to coverage under, and a declaration page relating to, the insurance policies required by Section 5.02(c) hereof and the applicable provisions of the Security Documents, each of which shall (A) be endorsed or otherwise amended to include a “standard” or “New York” lender’s loss payable or mortgagee endorsement (as applicable), (B) name the Collateral Agent, on behalf of the Secured Parties, as additional insured and loss payee/mortgagee, (C) identify the address of each property located in a Special Flood Hazard Area, the applicable flood zone designation and the flood insurance coverage and deductible relating thereto and (D) be otherwise in form and substance reasonably satisfactory to the Collateral Agent.

  • Regulatory Documentation means all applications, registrations, licenses, authorizations and approvals (including all Approvals), all correspondence submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority), all supporting documents and all Clinical Trials and tests, including the manufacturing batch records, relating to a Product, and all data contained in any of the foregoing, including all regulatory drug lists, advertising and promotion documents, adverse event files and complaint files.

  • Program Documentation refers to the user manuals, help windows, readme files for the Services and any Oracle Software. You may access the documentation online at xxxx://xxxxxx.xxx/contracts or such other address specified by Oracle.

  • Service documentation means all records and information on one or more documents, including documents that may be created or maintained in electronic software programs, created and maintained contemporaneously with the delivery of services, and kept in a manner as to fully disclose the nature and extent of services delivered that shall include the items delineated in paragraph (E) of this rule to validate payment for medicaid services.

  • Security Documentation means the Security Documentation applicable to the specific Services purchased by Client, as updated from time to time, or as otherwise made reasonably available by IRONSCALES.

  • Acquisition Documentation collectively, the Acquisition Agreement and all schedules, exhibits and annexes thereto and all side letters and agreements affecting the terms thereof or entered into in connection therewith.

  • Account Documentation means any and all Account information, credit applications, Cardholder Agreements and change in terms notices, Charge Transaction Data, charge slips, credit slips, payments, credit information and documents or forms of any type and in any media relating to the Program, excluding materials used for advertising or solicitations.

  • ISM Code Documentation includes, in respect of a Ship:

  • Computer software documentation means owner's manuals, user's manuals, installation instructions, operating instructions, and other similar items, regardless of storage medium, that explain the capabilities of the computer software or provide instructions for using the software.

  • Co-Documentation Agents as defined in the preamble hereto.

  • Co-Documentation Agent as defined in the preamble hereto.

  • Definitive Documentation means the definitive documents and agreements governing the Restructuring Transactions (including any related orders, agreements, instruments, schedules, or exhibits) that are contemplated by and referenced in the Plan (as amended, modified, or supplemented from time to time), including the following: (a) the Plan (and all exhibits, ballots, solicitation procedures, and other documents and instruments related thereto); (b) Definitive Documents (as defined in the Restructuring Support Agreement); (c) the Confirmation Order;

  • Programme Document means the formal document (in standard format) attached to this Agreement, which is concluded by the Parties and reflects expected results, detailed activities, timeframes and budget, and defines what is to be accomplished. The Programme Document is the basis for requisitioning, committing and disbursing funds to carry out planned activities and for their monitoring and reporting.

  • Contractor Documents means one or more document, agreement or other instrument required by Contractor in connection with the performance of the products and services being purchased by the State, regardless of format, including the license agreement, end user license agreement or similar document, any hyperlinks to documents contained in the Contractor Documents, agreement or other instrument and any other paper or “shrinkwrap,” “clickwrap,” “browsewrap” or other electronic version thereof.

  • RFP Documents means the following documents to be entered into by the parties to the respective agreements in connection with the supply of power:

  • Procurement Documents means the procurement documents attached hereto as Schedule F (if any);

  • Design Development Documents means the Drawings, Specifications and other documents prepared by the Trade Contractor that establish and describe the size and character of the Trade Contractor Work as to architectural, civil, structural, mechanical and electrical systems, graphics and signage, and other elements, and which include typical construction details, equipment layouts and specifications that identify major materials and systems.

  • Project Implementation Manual or “PIM” means the manual setting out the measures required for the implementation of the Project, as the same may be amended from time to time, subject to prior approval of the Association;