Conformance / Records Sample Clauses

Conformance / Records. 2.3.1 Biomet shall manufacture, package, label, and ship the Product in accordance with Applicable Laws and Biomet’s specifications for the Product. Without limiting the foregoing, Biomet agrees that, prior to each shipment of the Product hereunder, it shall perform quality control procedures reasonably necessary to ensure that the Product is free from defects. Each shipment of Product shall conform to Applicable Law and Biomet’s specifications therefor. Biomet shall notify BioCardia of any changes to such specifications. 2.3.2 Biomet shall generate and maintain complete and accurate records and samples as necessary to evidence compliance with this Agreement (including without limitation Section 2.3.1) and all Applicable Laws, and other requirements of applicable Regulatory Authorities relating to the manufacture, packaging, labeling, shipping and quality control of Product. All such books, records and samples shall be maintained during the Term of this Agreement and for two (2) years thereafter, or for such longer periods as may be required by Applicable Law and shall, during such period, be made available to BioCardia for inspection upon BioCardia’s reasonable request upon not less than thirty (30) days prior notice by BioCardia and not more than once per calendar year.

Related to Conformance / Records

  • Access to Records; Contractor Financial Records Contractor agrees that District and its authorized representatives are entitled to review all Contractor books, documents, papers, plans, and records, electronic or otherwise (“Records”), directly pertinent to this Contract for the purpose of making audit, examination, excerpts, and transcripts.

  • Time Records The employer will keep a record for a continuous period of seven (7) years from which can be readily ascertained the following:

  • Project Records Borrower shall: Make and keep books, records, and accounts, in such reasonable detail, so as to fully, accurately, and fairly reflect the activities of Borrower. Record the Project’s assets, liabilities, revenues, expenses, receipts and disbursements in separate accounts from any other assets, liabilities, revenues, expenses, receipts and disbursements of Borrower so as to permit the production of a Statement of Financial Position, a Statement of Profit and Loss (Statement of Activities), and a Statement of Cash Flows for Borrower in which the activities of Borrower are separately identifiable from the activities of the Operator, unless Borrower is also Operator. Devise and maintain a system of internal accounting controls sufficient to provide reasonable assurances that: Transactions are executed, and access to assets is permitted, only in accordance with ▇▇▇▇▇▇▇▇’s authorization; Transactions are accurately and timely recorded to permit the preparation of quarterly and annual financial reports in conformity with applicable Program Obligations; Transactions are timely recorded in sufficient detail so as to permit an efficient audit of the Borrower’s books and records in accordance with Generally Accepted Auditing Standards (GAAS), Generally Accepted Government Auditing Standards (GAGAS), and other applicable Program Obligations; and Transactions are timely recorded in sufficient detail so as to maintain accountability of the Borrower’s assets. The recorded accountability for assets shall be compared with the existing assets at reasonable intervals, but not less than annually, and appropriate action shall be taken with respect to any differences. Make the books, records and accounts of Borrower available for inspection by HUD or its authorized representatives, after reasonable prior notice, during normal business hours, at the Project or other mutually agreeable location or, at HUD’s request, shall provide legible copies of such documents to HUD or its authorized representatives within a reasonable time after HUD or its authorized representative makes a request for such documents. Include as a requirement in any operating or management contract that the books, records, and accounts of any agent of Borrower, as they pertain to the operations of the Project, shall be kept in accordance with the requirements of this Section 19 and be available for examination by HUD or its authorized representatives after reasonable prior notice during customary business hours at the Project or other mutually agreeable location or, at HUD’s request, the Management Agent shall provide legible copies of such documents to HUD or its authorized representatives within a reasonable time after HUD or its authorized representative makes the request.

  • Client Records 26.2.1 CONTRACTOR shall prepare and maintain accurate and complete records of clients served and dates and type of services provided under the terms of this Contract in a form acceptable to ADMINISTRATOR. 26.2.2 CONTRACTOR shall keep all COUNTY data provided to CONTRACTOR during the term(s) of this Contract for a minimum of five

  • Records; Audit Rights ▇▇▇▇▇▇ shall keep and maintain for [*****] years complete and accurate records of Development Costs incurred with respect to Co-Developed Products in sufficient detail to allow confirmation of same by Enanta. Enanta shall have the right for a period of [*****] years after such Development Cost is reconciled in accordance with Section 5.2 to inspect or audit, or to appoint, at its expense, an independent certified public accountant reasonably acceptable to ▇▇▇▇▇▇ to inspect or audit, the relevant records of ▇▇▇▇▇▇ and its Affiliates to verify that the amount of such Development Costs was correctly determined. ▇▇▇▇▇▇ and its Affiliates shall each make its records available for inspection or audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon reasonable notice from Enanta, solely to verify that Development Costs hereunder were correctly determined; provided that Enanta shall not have the right to inspect or audit any Calendar Year more than [*****] or more than [*****] years after the end of such Calendar Year or to conduct more than [*****] such audit in any [*****] month period. All records made available for inspection or audit shall be deemed to be Confidential Information of ▇▇▇▇▇▇. The results of each inspection or audit, if any, shall be binding on both Parties. In the event there was an error in the amount of Development Costs reported by ▇▇▇▇▇▇ hereunder, (a) if the amount of Development Costs was over-reported, ▇▇▇▇▇▇ shall promptly (but in any event no later than [*****] days after ▇▇▇▇▇▇’▇ receipt of the independent accountant’s report so concluding) make payment to Enanta of the over-reported amount and (b) if the amount of Development Costs was underreported, Enanta shall promptly (but in any event no later than [*****] days after Enanta’s receipt of the independent accountant’s report so concluding) make payment to ▇▇▇▇▇▇ of the underreported amount. Enanta shall bear the full cost of such audit unless such audit discloses an over-reporting by ▇▇▇▇▇▇ of more than [*****] of the aggregate amount of Development Costs reportable in any Calendar Year, in which case ▇▇▇▇▇▇ shall reimburse Enanta for all costs incurred by Enanta in connection with such inspection or audit.