FDA Tracking Information definition

FDA Tracking Information means the information relating to the Products that must be maintained pursuant to 21 U.S. Code of Federal Regulations Part 821 and any amendments or additions thereto.
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Examples of FDA Tracking Information in a sentence

  • In furtherance and not in limitation of the foregoing, upon reasonable prior written notice from Manufacturer, Purchaser shall provide to Manufacturer the FDA Tracking Information at the end of each calendar month (or earlier if required by relevant Applicable Law) if, and for so long as, the provision of such FDA Tracking Information has become mandatory under Applicable Law.

  • Manufacturer hereby covenants and agrees that for a minimum period of fifteen (15) years after the sale and purchase of any Product hereunder, it shall maintain complete and accurate records of the FDA Tracking Information for all Products, and all components thereof, that are manufactured and sold under this Agreement, to the extent necessary to meet or exceed all applicable FDA requirements and other Applicable Laws.

  • By contrast, the Senate bill would increase PBGC benefit guarantees by increasing PBGC insurance premiums for all multiemployer plans.

  • Supplier hereby covenants and agrees that for a minimum period of fifteen (15) years after the sale and purchase of any Product hereunder, it shall maintain complete and accurate records of the FDA Tracking Information for all Products, and all components thereof, that are manufactured and sold under this Agreement, to the extent necessary to meet or exceed all applicable FDA requirements and other Applicable Laws.

  • The participant shall complete any forms required by the public retirement fund from which the participant is requesting a transfer or the retirement plan created by this chapter before the transfer is made.

  • In the event that the FDA Tracking Information pursuant to 21 U.S. Code of Federal Regulations Part 821, and any amendments or additions thereto, has become mandatory for the Product, Dermworx shall provide the FDA Tracking Information relating to such Product the FDA with a copy to IGI.

  • In furtherance and not in limitation of the foregoing, upon reasonable prior written notice from Supplier, Purchaser shall provide to Supplier the FDA Tracking Information at the end of each calendar month (or earlier if required by relevant Applicable Law) if, and for so long as, the provision of such FDA Tracking Information has become mandatory under Applicable Law.

Related to FDA Tracking Information

  • 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;

  • 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.

  • Marketing Information means marketing studies, marketing analyses, and similar research and information designed to identify potential customers and business relationships.

  • Supporting information means the experience and judgment of the filer and the experience or data of other insurers or organizations relied on by the filer, the interpretation of any statistical data relied on by the filer, description or methods used in making the rates and any other similar information required to be filed by the commissioner.

  • Pricing Information means the information relating to (i) the number of Shares issued and (ii) the offering price of the Shares included on the cover page of the Prospectus.

  • Identifying information means information that identifies an individual or for which it is reasonably foreseeable in the circumstances that it could be utilized, either alone or with other information, to identify an individual.

  • Commercial Information means information regarding the purchase and sale of goods and services, including, but not limited to, information regarding marketing strategy, production data, assessments of goods and services, mineral exploration records, and compilations of data regarding commercial activity.

  • Program Information is defined in Section 13.8(a)(i).

  • Financing Information means (i) audited consolidated balance sheets and related statements of income, comprehensive income and cash flows of the Company and its Subsidiaries for the three most recently completed fiscal years ended at least 60 days prior to the Closing Date; (ii) unaudited interim consolidated balance sheets and related statements of income, comprehensive income and cash flows of the Company and its Subsidiaries for the fiscal quarter ended at least 60 days prior to the Closing Date (but excluding the fourth quarter of any fiscal year); and (iii) all other information regarding the Company and its Subsidiaries required by Regulation S-X and Regulation S-K under the Securities Act for an offering of securities of Parent on a registration statement filed with the SEC, in each case, of the type that would permit the Company’s independent auditors to deliver customary “comfort” (including customary “negative assurance” comfort) in connection with such offering which such auditors are prepared to provide upon completion of customary procedures.

  • Forward-Looking Information means disclosure regarding possible events, conditions or financial performance that is based on assumptions about future economic conditions and courses of action and includes future-oriented financial information with respect to prospective financial performance, financial position or cash flows that is presented as a forecast or a projection;

  • 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:

  • Listing Information means an Onvoy Customer’s primary name, address (including city, state and zip code), telephone number(s), the delivery address and number of directories to be delivered, and, in the case of a business Customer, the primary business heading under which the business Customer desires to be placed, and any other information Frontier deems necessary for the publication and delivery of directories.

  • Data Tape Information The information provided by the Responsible Parties as of the Cut-off Date to the Depositor or the Sponsor setting forth the following information with respect to each Mortgage Loan: (1) the Mortgagor's name; (2) as to each Mortgage Loan, the Scheduled Principal Balance as of the Cut-off Date; (3) the Mortgage Rate Cap; (4) the Index; (5) a code indicating whether the Mortgaged Property is owner occupied; (6) the type of Mortgaged Property; (7) the first date on which the Scheduled Payment was due on the Mortgage Loan and, if such date is not consistent with the Due Date currently in effect, such Due Date; (8) the "paid through date" based on payments received from the related Mortgagor; (9) the original principal amount of the Mortgage Loan; (10) with respect to Adjustable Rate Mortgage Loans, the Maximum Mortgage Rate; (11) the type of Mortgage Loan (i.e., Fixed Rate or Adjustable Rate Mortgage Loan, First Lien Mortgage Loan or Second Lien Mortgage Loan); (12) a code indicating the purpose of the loan (i.e., purchase, rate and term refinance, equity take out refinance); (13) a code indicating the documentation style (i.e., full, asset verification, income verification and no documentation); (14) the credit risk score (FICO score); (15) the loan credit grade classification (as described in the underwriting guidelines); (16) with respect to each Adjustable Rate Mortgage Loan, the Minimum Mortgage Rate; (17) the Mortgage Rate at origination; (18) with respect to each Adjustable Rate Mortgage Loan, the first Adjustment Date immediately following the Cut-off Date; (19) the value of the Mortgaged Property; (20) a code indicating the type of Prepayment Charges applicable to such Mortgage Loan (including any prepayment penalty term), if any; (21) with respect to each Adjustable Rate Mortgage Loan, the Periodic Mortgage Rate Cap; (22) the applicable Responsible Party with respect to such Mortgage Loan; (23) with respect to each First Lien Mortgage Loan, the LTV at origination, and with respect to each Second Lien Mortgage Loan, the CLTV at origination; and (24) if such Mortgage Loan is covered by a primary mortgage insurance policy or a lender-paid primary mortgage insurance policy, the primary mortgage insurance rate. With respect to the Mortgage Loans in the aggregate, the Data Tape Information shall set forth the following information, as of the Cut-off Date: (1) the number of Mortgage Loans; (2) the current aggregate outstanding principal balance of the Mortgage Loans; (3) the weighted average Mortgage Rate of the Mortgage Loans; and (4) the weighted average maturity of the Mortgage Loans.

  • User Information means User Compliance Information and User Financial Information.

  • Product Information has the meaning specified in Section 10.12(a).

  • 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;

  • Program Materials means the documents and information provided by the Program Administrator specifying the qualifying EEMs, technology requirements, costs and other Program requirements, which include, without limitation, program guidelines and requirements, application forms and approval letters.

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

  • Rating Information means any information provided for the purpose of determining the initial credit rating for the Notes or undertaking credit rating surveillance on the Notes (as contemplated by paragraph (a)(3)(iii)(C) of Rule 17g-5).

  • Licensed Information means any information concerning the Licensed Program, which is owned by the Licensor and is licensed to the Licensee together with the Licensed Program. Licensed Information includes such information as input form, user manual, interface format and input/output format and is delivered to and used by the Licensee as confidential information or proprietary property of the Licensor.

  • Program Know-How which means any and all Know-How that is created, conceived, discovered, first generated, invented, first made or first reduced to practice, in each case (i) by or on behalf of [***], (ii) by or on behalf of [***] or (iii) by or on behalf of [***], but expressly excluding any Joint Program Know-How.