Exhibit 10.5(d)
[GRAPHIC OMITTED]
Cephalon, Inc.
000 Xxxxxxxxxx Xxxxxxx
Xxxx Xxxxxxx, XX 00000
(000) 000-0000
Fax (000) 000-0000
July 21, 1993
Laboratoire X. Xxxxx
00 Xxxxxx xx Xxxxxxxxxx-Xxxxxx
00000 Xxxxxxx
Xxxxxx
Xxxxxx
Re: Amendment 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 ("License Agreement") between Cephalon, Inc.
("Cephalon") and Laboratoire X. Xxxxx ("Xxxxx") and (b) the Supply Agreement
dated January 20, 1993 ("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 Republic of Ireland and
the United Kingdom of England, Scotland, Northern Ireland and Wales
(collectively, the "U.K. Territory").
2. Appendix A to the License Agreement is hereby amended to add the
following patents and patent applications filed in the U.K. Territory as of the
date hereof:
U.K. Number 1 584 462 (filed March 31, 1977)
IR Number 46 566 (filed March 2, 1978)
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 roya1ties to be paid by Cephalon
pursuant to Section 1 of Article V of the License Agreement, the following
license fees totalling Eight Hundred Thousand US Dollars (USD 800,000):
a. One Hundred Thirty-Three Thousand US Dollars (USD 133,000),
payable upon Xxxxx'x signature of this letter agreement;
Laboratoire X. Xxxxx
Page 2
b. One Hundred Thirty-Three Thousand US Dollars (USD 133,000)
payable on each of the first through third anniversaries of the
date of this letter agreement; and
c. Two Hundred Sixty-Eight Thousand US Dollars (USD 268,000),
payable upon the initial regulatory approval of a Licensed
Product by the Medicines Division of the U.K. Ministry of Health.
4. The first sentence of Section 1 of Article VI of the License Agreement
shall apply to the U.K. Territory, except that the fifteen (15) year period
shall be calculated on a country-by-country basis within the U.K. Territory.
5. Section 1 of Article III of the License Agreement is hereby amended by
(a) inserting the phrase "or any other comparable regulatory applications and
filings to be made by Cephalon in the Territory" at the end of the second
sentence thereof, and (b) inserting the phrase "or other regulatory applications
and filings" at the end of the third sentence thereof.
6. Sections 3.b and 3.c of the License Agreement shall not apply to the
U.K. Territory. Instead, the following provisions shall apply to product
registration activities in the U.K. Territory:
3.b. CEPHALON and XXXXX shall promptly agree on a mutually acceptable
strategy for obtaining regulatory approvals of the Licensed Product in
the U.K. Territory to ensure that the approval process within the U.K.
Territory proceeds expeditiously, consistent with full and complete
laboratory and clinical evaluations and standards for new drug product
development applicable within the U.K. Territory. It is agreed that
all product registrations within the U.K. Territory are to be in
CEPHALON's name (or the name of a CEPHALON Affiliate). CEPHALON shall
have the right to meet with the appropriate regulatory authorities,
but shall keep XXXXX informed of all such meetings and shall provide
XXXXX with copies of all relevant correspondence with such
authorities.
If XXXXX, after consultation with CEPHALON, elects to file under the
multi-state procedure of the Committee for Proprietary Medicinal
Products ("CPMP") of the
Laboratoire X. Xxxxx
Page 3
European Communities, the parties will discuss the desirability of
keeping the approval process in the U.K. Territory separate from the
CPMP process, but it is understood that the final decision in this
regard shall be made by XXXXX. If the U.K. Territory remains part of
the CPMP process, XXXXX will provide CEPHALON with adequate
opportunity to provide input to any filings XXXXX proposes to make
with the CPMP.
XXXXX shall take such actions as may be required to identify CEPHALON
(or its designated Affiliate) as the holder of the product license in
all member states within the U.K. 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
Territory, and/or join in any such application by Cephalon, if
required."
3.c. CEPHALON shall conduct, at its own expense, all necessary trials for
purposes of obtaining regulatory approvals of the Licensed Product in
the U.K. Territory.
7. Section 3.d. of Article III of the License Agreement is hereby amended
and restated in its entirety as follows:
"If in any country within the Territory CEPHALON fails to market the
Licensed Product within three (3) months of the effective date of approval
of any application in such country, including price reimbursement approval
(and assuming receipt from XXXXX of Compound under the Supply Agreement),
to permit such sale in such country, upon sixty (60) days notice, XXXXX may
as its sole remedy, terminate CEPHALON's Exclusive License in such country,
and upon XXXXX'x request (and to the extent permitted by law), CEPHALON
will thereupon transfer its rights and approvals concerning the Licensed
Product in such country to XXXXX or its designated assignee."
8. Section 1.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 five per cent (5%) during the first three years from the date of
first
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Page 4
commercial sale of the first Licensed Product in any country within the
Territory, and seven per cent (7%) thereafter."
9. Section 2 of Article V of the License Agreement is hereby amended and
restated in its entirety as follows:
"Royalties shall be payable on Net Sales of Licensed Product in any country
within the Territory for a period of fifteen (15) years from the date of
the first commercial sale of the first Licensed Product in such country in
the Territory. Thereafter, CEPHALON's license granted under Article II
hereof shall be fully paid-up and irrevocable as to all Licensed Products
in such country in the Territory."
10. 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 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.
11. The term "FDA Standards" as used in the Supply Agreement is hereby
deleted and the term "Regulatory Standards" is hereby substituted in its place.
For purposes of the Supply Agreement, "Regulatory Standards" shall be defined as
follows: "the facility license requirements and the Good Manufacturing Practice
regulations of the U.S. FDA applicable to the Compound or the Manufacturing
Facility (as such terms are defined in the Supply Agreement) and all other laws,
rules and regulations applicable to the manufacture, packaging, labelling and
shipment of the Compound into the Territory."
12. Section 13 of the Supply Agreement is hereby amended so that the second
paragraph states in its entirety as follows:
"In addition, CEPHALON may terminate this Agreement, at its option, at any
time following termination of the License Agreement, upon thirty (30) days
written notice to XXXXX."
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Page 5
13. 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.
Except as modified by this letter agreement, all provisions of each of the
License Agreement and the Supply 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
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Xxxxx Xxxxxxx, Xx., Ph.D.
President
Accepted and agreed to this
_____ day of July, 1993.
LABORATOIRE X. XXXXX
By: /s/ X.X. Xxxxx
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X. X. Xxxxx
Chief Executive Officer
