Compliance Agreements ▼

[***] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS.

FDA COMPLIANCE AGREEMENT

        This FDA Compliance Agreement (the "Agreement") is made and entered into as of June 12, 2003 ("Date of Agreement"), by and between:

        Chiron S.r.l, having its registered office at Via Fiorentina 1, 53100 Siena, Italy;

and

        Chiron Behring GmbH & Co, with its registered offices at Emil von Behring Strasse 76, 35041 Marburg, Germany, together with Chiron S.r.l., hereafter referred to as "Chiron";

and

        SynCo Bio Partners B.V., having its registered office at Paasheuvelweg 30, 1105 BJ Amsterdam-Zuidoost, The Netherlands, hereinafter referred to as: "SynCo";

WHEREAS:

A.

Chiron has registered and commercially markets its Meningococcal C conjugate vaccine ("Menjugate") in (parts of) Europe and Canada;

B.

At the request of Chiron, SynCo has manufactured Chiron's MenC polysaccharide ("MenC") and CRM197 ("CRM197") for the European and Canadian market on the basis of that certain contract manufacturing agreement dated 26 July 2001;

C.

Chiron desires to register and commercially market its Menjugate in (parts of) the USA;

D.

Chiron has requested SynCo to manufacture as from [***] Chiron's MenC and CRM197 not only for the European, Canadian market and other international markets, but for the US market as well and with a view thereof, Chiron and SynCo have simultaneously with this agreement entered into that certain contract manufacturing agreement dated the date hereof (the "New Contract Manufacturing Agreement");

E.

With a view to the registration and launch of Chiron's Menjugate in the USA and SynCo's manufacturing of Chiron's MenC and CRM197, SynCo's facility at Paasheuvelweg 30 in Amsterdam-Zuidoost needs to be adjusted so as to fully comply with the requirements of the US Food and Drug Administration ("FDA");

F.

An assessement has been made by Chiron as to the adjustments to be made by SynCo to SynCo's facility at Paasheuvelweg 30 in Amsterdam-Zuidoost so as to fully comply with the requirements of the FDA;

G.

SynCo has expressed its willingness to manufacture Chiron's MenC and CRM197 for both the European, Canadian and other international markets as well as the US market, provided that Chiron contributes a certain amount for the adjustments that are required to fully comply with the FDA requirements and for the loss of revenues that will occur during the time that the adjustments to SynCo's facility will be made;

H.

Chiron and SynCo have agreed on the amount and terms of the contribution to be paid by Chiron to SynCo in respect of the adjustments and on certain other issues;