Common use of Product Certification Clause in Contracts

Product Certification. (i) Biochrom shall manufacture the Products in strict conformance with all agreed applicable requirements, such as CE Marking, UL, IEC, CSA, MHLW, CCC, or equivalent applicable regulatory body, each as may be modified from time to time, and maintain the same at Biochrom’s sole expense. Unless agreed to otherwise in writing, if a party proposes a change in purchase specification, that party shall be responsible for any additional Product certification or regulatory approval costs that may be necessary. See the Compliance section of Attachment B. (ii) Upon GE Healthcare’s request, Biochrom shall provide GE Healthcare, GE Healthcare’s notified body, or the appropriate regulatory authority, with a copy of all regulatory certification reports including, but not limited to, technical documentation (set up according to Annexes II.4, or III from EU Directives 90/385/CEE- 93/42/CEE; Annexe VII from Directive 93/42/CEE; the annexe from Directive 2003/32/CE; and Annexe III from Directive 98/79/CE). Biochrom shall also comply, at its own costs, with international quality standards ISO9001:2000 as may be modified from time to time.