PORTIONS OF THIS DOCUMENT HAVE BEEN OMITTED (DESIGNATED BY AN ASTERISK (*)
AND WHITE SPACE) AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT
DATED AUGUST 4, 1998; FILE NO. 0-15609
AMENDMENT TO THE VIRACEPT (Nelfinavir Mesylate) LICENSE AGREEMENT
This Amendment ("Amendment") to the VIRACEPT (Nelfinavir Mesylate) License
Agreement ("the Agreement"), effective as of this 1st day of May, 1998
("Effective Date"), is between Agouron Pharmaceuticals, Inc., a corporation duly
organized and existing under the laws of the state of California, having a
principal place of business at 00000 Xxxxx Xxxxxx Xxxxx Xxxx, Xx Xxxxx,
Xxxxxxxxxx, Xxxxxx Xxxxxx of America (hereinafter referred to as "Agouron"),
Japan Tobacco Inc., a corporation duly organized and existing under the laws of
Japan, having its principal place of business at JT Xxxxxxxx, 0-0, Xxxxxxxxx
0-xxxxx, Xxxxxx-xx, Xxxxx, Xxxxx (hereinafter referred to as "JT"), and
X. Xxxxxxxx-Xx Xxxxx Ltd, a corporation duly organized and existing under the
laws of Switzerland, having its principal place of business at XX-0000-Xxxxx,
Xxxxxxxxxxx (hereinafter referred to as "Roche"). Agouron, JT and Roche are each
sometimes hereinafter referred to as a party (collectively "parties"). The
parties for good and valuable consideration hereby agree as follows:
RECITALS
1. Background
1.01 All capitalized terms, except as expressly otherwise defined herein,
shall have the meanings set forth in the Agreement.
1.02 Agouron, JT and Roche entered into a Letter of Intent on January 17,
1997 and the VIRACEPT (nelfinavir mesylate) License Agreement dated for
reference purposes only June 30, 1997, under which Agouron and JT granted, and
Roche received, a license in the Licensed Territory to use, offer for sale, sell
and/or import Products in the Field under applicable Agouron/JT Patent Rights
and Development Program Patent Rights and using applicable Agouron/JT
Technology, Roche Technology and Development Program Technology.
1.03 Roche has certain capacities to manufacture Compound as well as
formulate Product. Roche has informed Agouron and JT of its desire to
manufacture Compound and formulate Product to be sold and/or distributed in the
Licensed Territory with such Roche manufacturing and formulating
responsibilities to be phased-in over an agreed-to period of time.
1.04 The parties, in accordance with the provisions of Section 4.04(f) of
the Agreement, have discussed in good faith an arrangement under which Roche
could be the manufacturer of Compound and the formulator of Product to be sold
and/or distributed in the Licensed Territory.
1.05 Agouron and JT under certain conditions are willing to xxxxx Xxxxx
certain rights to manufacture Compound and formulate Product to be sold and/or
distributed in the Licensed Territory.
1.06 *
1.07 *
1.08 To effect the preceding and clarify the parties' rights and
obligations under the Agreement, the parties wish to amend the Agreement as
provided below.
AMENDMENT
2. Grant of Rights to Roche
2.01 *
2.02 *
2.03 *
2
2.04 Except as otherwise specifically provided in the Agreement, *
2.05 All licenses granted Roche in this Amendment in a country shall become
*
2.06 Roche shall not have the right to use *
3. Limitations
3.01 Roche's rights to manufacture Compound and formulate Product shall *
3.02 *
3
(a) *
(b) *
(c) *
(d) *
4
3.03 *
5
4. Markup
4.01 For the rights granted pursuant to the provisions of Paragraphs
2.01-2.04, *
5. License grant to Agouron and JT
5.01 Roche grants Agouron and JT *
5.02 For the rights granted pursuant to the provisions of Paragraph 5.01, *
5.03 *
6
6. Exchange of Information
6.01 Immediately after execution of this Amendment by the parties, and
on an ongoing basis thereafter, *
7. Supply obligations
7.01 *
7.02 *
7.03 *
(a) *
(b) *
7
(c) *
(d) *
(e) *
(f) *
7.04 *
8
7.05 *
8. Schedule 2 of Agreement
8.01 *
9. Trademark/Labeling
9.01 The labeling for any Product to be sold and/or distributed by Roche, *
9
10. Remaining Agreement Terms
10.01 Except as expressly amended by the terms contained in this
Amendment, the provisions of the Agreement, as previously amended, shall
remain in full force and effect.
IN WITNESS WHEREOF, the parties have caused their duly authorized
representatives to enter into this Amendment to the VIRACEPT(TM)(Nelfinavir
Mesylate) License Agreement, effective as of the Effective Date.
AGOURON PHARMACEUTICALS, INC. JAPAN TOBACCO INC.
By: /s/ Xxxx Xxxxxxxx By: /s/ Masakazu Kakei
Name: Xxxx Xxxxxxxx Name: Masakazu Kakei
Title: Corp. Vice President Title: Executive Director
By:/s/ R. Xxxx Xxxxxx By: /s/ Xxxxxxx Xxxxxxxx
Name: R. Xxxx Xxxxxx Name: Xxxxxxx Xxxxxxxx
Title: Sr. Vice President Title: Vice President, Business Devel.,
Pharmaceuticals Division
X. XXXXXXXX-XX XXXXX LTD
By /s/ St. Xxxxxx
Name: St. Xxxxxx
Title: Vice Director
By: /s/ X. Xxxxxx
Name: X. Xxxxxx
Title: Vice Director
10
SCHEDULE 1
*
S1-1
SCHEDULE 2
ROCHE DEMAND SCHEDULE FOR VIRACEPT PRODUCT
*
S2-1
SCHEDULE 2
ROCHE DEMAND SCHEDULE FOR VIRACEPT PRODUCT
*
S2-2
SCHEDULE 2
ROCHE DEMAND SCHEDULE FOR VIRACEPT PRODUCT
*
S2-3
SCHEDULE 2
ROCHE DEMAND SCHEDULE FOR VIRACEPT PRODUCT
*
SCHEDULE 2
ROCHE DEMAND SCHEDULE FOR VIRACEPT PRODUCT
*
S2-4
SCHEDULE 2
ROCHE DEMAND SCHEDULE FOR VIRACEPT PRODUCT
*
S2-5
ATTACHMENT 1
1. *
2. *
3. *
4. *
5. *
6. *
