Exhibit 99.1*
[LETTERHEAD OF CEPHALON, INC. APPEARS HERE]
January 3, 1994
Laboratoire X. Xxxxx
00 Xxxxxx xx Xxxxxxxxxx-Xxxxxx
00000 Xxxxxxx
Xxxxxx
Xxxxxx
Re: Amendment No. 2 to License Agreement
------------------------------------
Gentlemen:
This letter agreement shall serve as the second amendment to the License
Agreement dated January 20, 1993 between Cephalon, Inc. ("Cephalon") and
Laboratoire X. Xxxxx ("Xxxxx"), as previously amended by letter agreement dated
July 21, 1993 ("License Agreement"). All capitalized terms not otherwise defined
herein shall be used as defined in the License Agreement.
1. The parties wish to postpone by six months the dates by which
Cephalon is to perform certain obligations under the License Agreement to allow
the parties additional time to obtain GMP-grade formulation of the Compound.
Specifically, the following provisions are hereby amended:
(a) The last sentence of the second paragraph of Article III,
paragraph 3.b. of the License Agreement is amended to read as follows:
"In addition, CEPHALON will endeavor to file a New Drug
Application ("NDA") with the FDA within thirty (30) months from the date
CEPHALON files the IND for such Licensed Product, provided that CEPHALON shall
not be deemed to be in breach of these obligations if the FDA requires CEPHALON
to submit any additional preclinical data other than the data furnished by XXXXX
to CEPHALON immediately following the execution of this Agreement, or for any
other reason outside of CEPHALON's control."
* Certain portions of this exhibit have been
omitted based upon a request for confidential
treatment that has been filed with the
Commission. The omitted portions have been
filed separately with the Commission.
Laboratoire X. Xxxxx
Page 2
(b) Article V, paragraph 1.a. of the License Agreement is
amended to read as follows:
"a. CEPHALON shall pay to XXXXX the following license
fees as compensation for its rights in the Territory (excluding
the U.K. Territory):
-[ ** ]US dollars (USD[ ** ]) upon
signature of this Agreement (receipt of which is acknowledged by
Xxxxx),
-[ ** ]US dollars (USD[ ** ])
-July 20, 1994,
-[ ** ]US dollars (USD[ ** ])
-July 20, 1995,
-[ ** ]US dollars (USD[ ** ])
-July 20, 1996,
-[ ** ]US dollars (USD[ ** ])
-upon the first U.S. FDA approval of a Licensed Product."
(c) Paragraphs 3.b. and 3.c. of Article III of the License
Agreement do not apply to the U.K. Territory. Instead, Cephalon's obligation to
pay compensation to Xxxxx for Cephalon's rights in the U.K. Territory arises
under Section 3.a. of the letter agreement dated July 21, 1993, which is amended
as follows:
"a. [ ** ]US Dollars
(USD[ ** ]), payable upon Xxxxx'x signature of the
letter agreement (receipt of which is acknowledged by
Xxxxx);
b. [ ** ]US Dollars
(USD[ ** ]), payable on January 31, 1995; and
c. [ ** ]US Dollars
(USD[ ** ]), payable on January 31, 1996;
d. [ ** ]US Dollars
(USD[ ** ]), payable on January 31, 1997;
** The confidential material contained
herein has been omitted and has been
separately filed with the Commission.
Laboratoire X. Xxxxx
Page 3
e. [ ** ]US Dollars
(USD[ ** ]), payable upon the initial regulatory approval of a Licensed
Product by the Medicines Division of the U.K. Ministry of Health."
2. Each of Cephalon and Xxxxx hereby restates its representations and
warranties made in the License Agreement, as amended pursuant to this letter
agreement.
3. Except as modified by this letter agreement, all provisions of the
License Agreement are confirmed to be and shall remain in full force and effect.
If the foregoing is acceptable, please indicate your agreement in the
space provided below.
CEPHALON, INC.
By: /s/ Xxxxx Xxxxxxx, Xx.
-----------------------------
Xxxxx Xxxxxxx, Xx., Ph.D.
President
Accepted and agreed to this
17/th/ day of January, 1994.
-----
LABORATOIRE X. XXXXX
By: /s/ X. X. Xxxxx
-----------------------
X. X. Xxxxx
Chief Executive Officer
** The confidential material contained
herein has been omitted and has been
separately filed with the Commission.
