Exhibit 10.5(i)
[LOGO OF CEPHALON APPEARS HERE]
February 2, 1998
Laboratoire X. Xxxxx
00 Xxxxxx xx Xxxxxxxxxx-Xxxxxx
00000 Xxxxxxx Xxxxxx
Xxxxxx
RE: Amendment No. 6 to License Agreement and Supply Agreement
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Gentlemen:
This letter agreement shall serve as an amendment to (a) the License
Agreement dated January 20, 1993, as previously amended ("License Agreement")
between Cephalon, Inc. ("Cephalon") and Laboratoire X. Xxxxx ("Xxxxx"), and (b)
the Supply Agreement dated January 20, 1993, as previously amended (the "Supply
Agreement") between Cephalon and Xxxxx. All capitalized terms not otherwise
defined herein shall be used as defined in the License Agreement.
1. The term "Territory," for all purposes under the License Agreement and
the Supply Agreement, is hereby expanded to include the Republics of Italy and
San Marino (collectively, the "Italian Territory").
2. Appendix A to the License Agreement is hereby amended to add all
patents and patent applications related to the composition, manufacture or use
of modafinil, as filed or registered in the Italian Territory as of the date
hereof, including, without limitation, the following:
European Patent 91 401 563.1
European Patent 92 403 381.4
3. In consideration of the expansion of the Territory, Cephalon shall pay
to Xxxxx, in addition to the license fees and royalties to be paid by Cephalon
for other licensed territories pursuant to Section 1 of Article V of the License
Agreement and previous letter agreements, the following license fees totaling
[*] US Dollars (USD[*]):
a. [*] US Dollars (USD [*]), payable upon Xxxxx'x signature of this
letter agreement;
* THE CONFIDENTIAL MATERIAL CONTAINED
HEREIN HAS BEEN OMITTED AND HAS BEEN
FILED SEPARATELY WITH THE COMMISSION.
Laboratoire X. Xxxxx
February 2, 1998
Page -2-
b. [*] US Dollars (USD [*]), payable upon the initial regulatory
approval of a Licensed Product by the Italian Ministry of Health.
4. Sections 3.b and 3.c of the License Agreement shall not apply to the
Italian Territory. Instead, the following provisions shall apply to product
registration activities in the Italian Territory:
3.b. It is agreed that all product registrations (and applications)
within the Italian Territory are to be in CEPHALON's name (or the
name of a CEPHALON Affiliate or sublicensee). XXXXX shall take
such actions as may be required to identify CEPHALON (or its
Affiliate or sublicensee) as the applicant and the holder of the
product license within the Italian Territory, and, upon request,
shall sign any instruments required by applicable law to confirm
Cephalon's authorization under this Agreement to apply for any
other authorizations required to market the Licensed Product in
the Italian Territory, and/or join in any such application by
Cephalon, if required. CEPHALON and/or its sublicensee shall have
the right to meet with the appropriate regulatory authorities
(including pricing and reimbursement authorities), but shall keep
XXXXX informed of all such meetings and, upon request, shall
provide XXXXX with copies of all relevant correspondence with
such authorities.
3.c. CEPHALON shall conduct, at its own expense, all necessary trials
for purposes of obtaining regulatory approvals of the Licensed
Product in the Italian Territory.
3.x. XXXXX will furnish CEPHALON, upon request, copies of
correspondence and communications whether occurring prior to the
date hereof or hereafter between XXXXX and the Italian regulatory
authorities related to applications for marketing approval for
the Licensed Product in the Italian Territory.
5. Section l.b. of Article V of the License Agreement is hereby amended
and restated in its entirety as follows:
"In addition, CEPHALON shall pay to XXXXX a royalty on Net Sales of
Licensed Products by CEPHALON and/or its sublicensees, calculated at the
rate of [*] per cent ([*]) during the first [*] from the date of first
commercial sale of the first Licensed Product in each country within the
Territory, and [*] per cent ([*]) thereafter in such country."
*THE CONFIDENTIAL MATERIAL CONTAINED HEREIN
HAS BEEN OMITTED AND HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.
Laboratoire X. Xxxxx
February 2, 1998
Page -3-
6. Xxxxx and Cephalon shall cooperate to take all actions that are
reasonably available under applicable laws to extend the term of each of the
Patents in the Italian Territory including, without limitation, applying for a
"Supplementary Protection Certificate" pursuant to Council Regulation (EEC) No.
1768/92 of 18 June, 1992 of The Council of the European Communities. The out-of-
pocket costs and expenses associated with such actions shall be shared equally
by the parties.
7. Each of Cephalon and Xxxxx hereby restates its respective
representations and warranties made in the License Agreement and the Supply
Agreement, as each such agreement has been amended pursuant to this letter
agreement. Xxxxx confirms that it is free to enter into this letter agreement,
without obligation to any third party. Cephalon shall not be responsible to any
third party asserting a claim through Xxxxx with respect to the development,
manufacture or sale of Licensed Product for the Italian Territory.
8. Except as specifically supplemented by this letter agreement, all
provisions of each of the License Agreement and the Supply Agreement (in each
case, as amended prior to the date hereof) 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 X. Xxxxxxx
----------------------------
Xxxxx X. Xxxxxxx,
Executive Vice President
and Chief Operating Officer
Accepted and agreed to this
10th of February, 1998.
LABORATOIRE X. XXXXX
By: /s/ X.X. Xxxxx
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X.X. Xxxxx
Chief Executive Officer
