Common use of Conformance / Records Clause in Contracts

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.