The settlement was concluded on Wednesday last with the receipt of the settlement funds by DRL, the company stated in a press release.
The case was brought by DRL in April 2009 seeking damages sustained by the company caused by a claimed breach by Nordion (then MDS) of its laboratory services agreement with DRL.
Nordion, as a contract research organization, provided laboratory services to DRL, including bio-equivalency studies, to support DRL’s regulatory applications for approval of generic drugs, including abbreviated new drug applications (ANDAs) filed with the United States Food and Drug Administration (USFDA) for approval to market generic drugs in the US.
According to DRL, the case arose after the USFDA cited MDS with violations of good laboratory practices which caused the USFDA not to accept, without further substantiation, MDS’s laboratory reports performed during the period 2000-2004.
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