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Biotech / Medical : Chromatics Color Sciences International. Inc; CCSI
CCSI 29.69+5.8%2:31 PM EDT
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To: JanyBlueEyes who wrote (4754)11/13/1998 9:39:00 AM
From: JanyBlueEyes  Read Replies (2) of 5736
 
Manufacturing Info

From the 8-K filed with the SEC on 11/12/98:

1. On November 3, 1998, Chromatics Color Sciences International, Inc. (the "Company") executed a renewable four-year medical device manufacturing agreement under which the contract manufacturer is the exclusive manufacturer/assembler and packager of two models of the Company's instrument for noninvasive monitoring of bilirubin infant jaundice for distribution in the United States (subject to limited volume exceptions with respect to one model of the instrument).

The manufacturer also has a right of first refusal to match third-party bids to manufacture/assemble and package a third model of such instrument and a further right of first refusal to match third-party bids to manufacture/assemble and package the two models referenced above for distribution outside the United States.

In this regard, subject to any failure of the manufacturer to exercise its right of first refusal to match third-party bids (thus permitting the Company to use other manufacturers), the manufacturer is the Company's sole source of supply for the instruments. Under the agreement, the Company is responsible for providing to the manufacturer, for assembly and packaging, certain component parts.

The manufacturer is a medical device production contractor and has advised the Company that it is in compliance with all applicable regulatory requirements for the contract manufacture of medical devices for U.S. and European Union distribution, including requirements under the U.S. Food and Drug Administration's Quality System Regulation, and the requirements applicable to the manufacture of medical devices for the European Union (including ISO 9001 and EN46001).
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