[ * ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange Act of 1934, as amended.
FIRST AMENDMENT TO DEVELOPMENT
AND LICENSE AGREEMENT
This First
Amendment to the Development and License Agreement (the
“First Amendment”) is made and entered into effective
as of October 22, 2001 (the “Effective Date”), by
and between Novo Nordisk A/S, Novo Allé DK-2880
Bagsværd, Denmark (“Novo Nordisk”), and Aradigm
Corporation, 3929 Point Eden Way, Hayward, California 94545
(“Aradigm”). Novo Nordisk and Aradigm may be referred
to herein as a “Party” or, collectively, as
“Parties”.
WHEREAS, effective
June 2, 1998, Novo Nordisk and Aradigm entered into a
Development and License Agreement (the “Development
Agreement”) for the development and commercialization of a
system for pulmonary delivery of insulin (and potentially other
related compounds);
WHEREAS, pursuant
to the Development Agreement, Aradigm granted Novo Nordisk an
exclusive, worldwide license under Aradigm’s Patent Rights
and Know-how, to register, use, market, distribute, sell, with
sublicense rights, and certain rights to package and produce
products resulting from such development activities; and
WHEREAS
, the Parties desire
to amend the Development Agreement to correspond with the
Manufacturing and Supply Agreement entered into between Novo
Nordisk and Aradigm on October 22, 2001.
Now Therefore , the Parties
agree as follows:
1. Amendment
of the Development Agreement .
The Parties
hereby agree to amend the terms of the Development Agreement as
provided below. To the extent that the Development Agreement is
explicitly amended by this Amendment, the terms of the Amendment
will control where the terms of the Agreement are contrary to or
conflict with the following provisions. Where the Development
Agreement is not explicitly amended, the terms of the Agreement
will remain in force. Capitalized terms used in this Amendment that
are not otherwise defined herein shall have the meanings as such
terms are defined in the Agreement.
1.1
Article 1.12 of the Development Agreement is hereby deleted in
its entirety and replaced with the following:
“1.12
Fully Burdened Costs” shall mean the cost of raw materials
(excluding unless otherwise stated the Programme Compound),
components, labour (production), quality (labour, material and
external analysis), third party royalties, freight, import duties,
taxes and reasonably allocated facilities,
