FIRST AMENDMENT TO DEVELOPMENT AND LICENSE AGREEMENT
EXHIBIT 10.30
[ * ] = 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
Xxxxxxx X/X, Xxxx Xxxx XX-0000 Xxxxxxxx, Xxxxxxx (“Novo Nordisk”), and Aradigm Corporation, 0000
Xxxxx Xxxx Xxx, Xxxxxxx, Xxxxxxxxxx 00000 (“Aradigm”). Novo Nordisk and Aradigm may be referred to
herein as a “Party” or, collectively, as “Parties”.
RECITALS
WHEREAS, effective Xxxx 0, 0000, Xxxx Xxxxxxx 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:
AGREEMENT
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, depreciation of equipment, product and professional support, and
manufacturing overheads relating to the production of the specified items.”
1.
1.2 Article 4.9(h) of the Development Agreement is hereby amended by deleting the sentence “In
such case ARADIGM shall continue to be entitled to receive on an ongoing basis its [ * ] as
specified in Article 5.2, but reduced by the [ * ] associated with the transfer prices, as
specified in Articles 4.5 and 4.6, which shall be retained by NOVO NORDISK as compensation for
being required to undertake the manufacturing function”, and replacing such sentence with the
following:
“In such case ARADIGM shall be entitled to, and NOVO NORDISK shall pay, all amounts owed
under Articles 5.2 and 5.5 of the Development Agreement with respect to ARADIGM’s [ * ] on
Net Sales of such Packaged Product, but, for clarification purposes, Aradigm will not
receive payments of the interim transfer price pursuant to Article 4.5.”
1.3 Article 4.11 of the Development Agreement is hereby amended by deleting the sentence
“ARADIGM shall continue to share in the Gross Profit associated with Packaged Products produced in
this facility as specified by Article 5 (with the [ * ] of product produced at such facility to be
included in the calculation of Gross Profit)”, and replacing such sentence with the following:
“ARADIGM shall continue to share in the Gross Profit associated with Packaged Products
produced in this facility as specified by Article 5 (with the [ * ] of product produced at
such facility to be included in the calculation of Gross Profit), but, for clarification
purposes, Aradigm will not receive payments of the interim transfer price pursuant to
Article 4.5.”
1.4 Article 5.2 of the Development Agreement is hereby amended by deleting the sentence “In
addition to the payments referred to in Article 5.1 above, each year during the term of this
Agreement NOVO NORDISK shall pay to ARADIGM [ * ] on Net Sales of the Packaged Products and the
Devices during such year; provided, however, that a different percentage may be applicable to
Packaged Products containing Other Compounds as agreed by the parties pursuant to Article 2.1”,
and replacing such sentence with the following:
“In addition to the payments referred to in Article 5.1 above, each year during the term of
this Agreement NOVO NORDISK shall pay to ARADIGM [ * ] on Net Sales of the Packaged Products
and the Devices during such year; provided, however, that a different percentage may be
applicable to Packaged Products containing Other Compounds as agreed by the parties pursuant
to Article 2.1.”
2. Miscellaneous
2.1 Full Force and Effect. This Amendment amends the terms of the Agreement and is deemed
incorporated into, and governed by all the other terms of, the Development
Agreement. The provisions of the Development Agreement, as amended by this Amendment, remain
in full force and effect.
2.2 Counterparts; Facsimile. This First Amendment may be executed in counterparts and by
facsimile.
[ * ] = 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.
2.
In Witness Whereof, the Parties have executed this First Amendment as of the
Effective Date.
| Novo Nordisk A/S | Aradigm Corporation | |||||||||
| Novo Allé DK-2880 | 0000 Xxxxx Xxxx Xxx | |||||||||
| Xxxxxxxx, Xxxxxxx | Xxxxxxx, XX 00000 | |||||||||
By:
|
/s/ Kåre Xxxxxxx | By: | /s/ Xxxxxxx X. Xxxxxxxx | |||||||
Name:
|
Name: | |||||||||
Title:
|
Executive Vice President | Title: | Chairman, President and Chief Executive Officer | |||||||
[ * ] = 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.
3.
