definiens: means the document provided to AMAG by Antaresor the Subcontractor that conducted the applicable review, as the case may be, that certifieseach batch of each of the Major Device Components was manufactured in compliance withthe cGMP, all other Applicable Laws, and the Product Specifications ; means the document provided to AMAG byAntares or the Subcontractor that conducted the applicable review, as the case may be, thatcertifies each batch of Product and/or sample Product was assembled, packaged andlabelled in compliance with the cGMP, all other Applicable Laws, and the ProductSpecifications ; means current good manufacturing practice and standards as provided for ( and asamended from time to time ) in the of theU.S. Code of Federal Regulations Title 21 ( 21CFR§4 ; 21CFR§210/211 and 21CFR§820)and in European Community Council Directive 93/42 / EEC concerning medical devices, anyU.S., European, or other applicable laws, regulations or respective guidance documentsnow or subsequently established by a governmental or regulatory authority, and anyarrangements, additions, or clarifications ; has the meaning specified in Section 4.2(b ) ; means, with respect to each Party, such efforts andcommitment of resources in accordance with [ * * * ] that such Party [ * * * ] . As used in thisdefinition of, shall be measured by [ * * * ]