EXHIBIT 4.3(H)
THE CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT
REQUEST IN ACCORDANCE WITH RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF
1934, AS AMENDED. REDACTED PORTIONS OF THIS EXHIBIT ARE MARKED BY AN ***.
SECOND AMENDMENT TO THE LICENSE AGREEMENT BETWEEN
VERNALIS DEVELOPMENT LIMITED
AND
ENDO PHARMACEUTICALS INC.
DATED JULY 14, 2004
This Second Amendment to the License Agreement by and between Vernalis
Development Limited ("Vernalis") and Endo Pharmaceuticals Inc. ("Endo") (the
"Second Amendment") is effective as of December 12, 2005.
WHEREAS, Vernalis and Endo entered into a License Agreement dated July 14, 2004
as amended by a letter agreement dated January 31, 2005 (the "License"), whereby
Vernalis licensed to Endo certain rights to the Product; and
WHEREAS, Vernalis and Endo wish to further amend the License to address the
Commercialisation of the Product in Canada;
NOW THEREFORE, for good and valuable consideration, the receipt of which is
hereby acknowledged, the parties hereto agree as follows:
1. Unless set forth herein, the capitalized terms contained in this Second
Amendment shall have the meanings set forth in the License.
2. The following Definitions shall be added to the License as follows:
1.1.5A "CANADIAN TRADEMARK" - any name, xxxx or logo, to be used,
registered, owned and maintained by Endo in Canada in association with
the Product.
1.1.96.1 "CANADIAN TERRITORY" - Canada.
1.1.96.2 "MEXICAN TERRITORY" - Mexico
1.1.96.3 "US TERRITORY" - the United States of America, its territories and
possessions and the Commonwealth of Puerto Rico
and the following existing Definitions shall be deleted and replaced in
their entirety as follows:
1.1.82 "REGISTERED TRADEMARKS" US Federal Trademark Registration No.
2,828,476 registered on March 30, 2004 for FROVA.
1.1.37 "ENDO TRADE MARKS" (i) the name and xxxx XXXX and the associated
Endo logo, (ii) the Canadian Trademark and (iii) any other trade marks
other than the
Vernalis Trade Marks used in relation to Products owned by or licensed
to Endo during the term of this Agreement which are the subject of
clause 13.1
3. Clause 3.1 of the License is amended to add the following sentence to the
end of such clause:
"Vernalis further grants to Endo and its Affiliates from the date of this
Second Amendment a sole and exclusive (even as against Vernalis) license to
make, have made, use, Commercialise and have Commercialised the Product
under the Canadian Trademark in the Canadian Territory."
4. Clause 6.1.2 and 6.1.3 of the License is amended such that the terms
therein apply only to Product in the "US Territory." Clause 6.1.2.1 is
hereby added as follows:
"Upon the later of (i) thirty (30) days following the conclusion of an
agreement between Endo and a marketing partner in relation to the Canadian
Territory or (ii) six (6) months prior to the first commercial sale of
Product in Canada, Endo shall provide to Vernalis a marketing plan for the
period commencing on the anticipated date of commencement of marketing
activity in the Canadian Territory and ending on the last day of that Year,
and thereafter no later than one month prior to the lst day of each Year
after which such marketing activity has been initiated, an Annual Marketing
Plan and Budget for the Canadian Territory, which shall contain the
information set forth in Schedule 9."
5. The table in Section 9.1 is hereby deleted and replaced with the following:
YEARS 2006 2007 2008 2009 2010
----- ---- ---- ---- ---- ----
Maximum no. of Details *** *** *** *** ***
to be reimbursed
% of Cost per Detail *** *** *** *** ***
where all Vernalis
Specialty Sales
Personnel Detail only
the Product
% of Cost per Detail *** *** *** *** ***
where any Vernalis
Specialty Sales
Personnel Detail one
or more other products
6. Clause 11.9.1 of the License is amended to substitute "Territory" with "US
Territory." The following sentence shall be added to the end of Clause
11.9.1:
"Notwithstanding the foregoing, under no circumstances shall royalties be
payable on Net Sales of Product in the Canadian Territory on or before
December 31, 2006."
7. The first line of Clause 11.9.2 of the License is deleted in its entirety
and replaced with the following:
"If Marketing Authorisation for Product for the MAM indication has not been
approved in the US Territory, then royalties for Product sold in the US
Territory shall be calculated as follows:"
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The remainder of Clause 11.9.2 is amended by substituting "Territory" with
"US Territory" throughout.
8. The first line of Clause 11.9.3 of the License is deleted in its entirety
and replaced with the following:
"If Marketing Authorisation for Product for the MAM indication has been
approved in the US Territory, then royalties for Product sold in the US
Territory shall be calculated as follows for Net Sales subsequent to the
effective date of such Marketing Authorisation in the US Territory:"
The remainder of Clause 11.9.3 is amended by substituting "Territory" with
"US Territory" throughout.
9. The License is amended to add a new Clause 11.9.4 as follows:
"If Marketing Authorisation for Product for the MAM indication has not been
approved in the Canadian Territory, then royalties for Product sold in the
Canadian Territory shall be calculated as follows:
royalty = A + B + C + D + E
where,
A equals *** of that portion of aggregate Net Sales of Product in the
Canadian Territory, which, during the Year in question, is less than or
equal to ***;
B equals *** of that portion of aggregate Net Sales of Product in the
Canadian Territory, which, during the Year in question, is greater than ***
and less than or equal to ***;
C equals *** of that portion of aggregate Net Sales of Product in the
Canadian Territory, which, during the Year in question, is greater than ***
and less than or equal to ***;
D equals *** of that portion of aggregate Net Sales of Product in the
Canadian Territory, which, during the Year in question, is greater than ***
and less than or equal to ***; and
E equals *** of that portion of aggregate Net Sales of Product in the
Canadian Territory, which, during the Year in question, is greater than
***."
10. The License is amended to add a new Clause 11.9.5 as follows:
"If Marketing Authorisation for Product for the MAM indication has been
approved in the Canadian Territory, then royalties for Product sold in the
Canadian Territory shall be calculated for Net Sales subsequent to the
effective date of such Marketing Authorisation in the Canadian Territory as
follows:
royalty = A + B + C + D + E
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where,
A equals *** of that portion of aggregate Net Sales of Product in the
Canadian Territory, which, during the Year in question, is less than or
equal to ***;
B equals *** of that portion of aggregate Net Sales of Product in the
Canadian Territory, which, during the Year in question, is greater than ***
and less than or equal to ***;
C equals *** of that portion of aggregate Net Sales of Product in the
Canadian Territory, which, during the Year in question, is greater than ***
and less than or equal to ***;
D equals *** of that portion of aggregate Net Sales of Product in the
Canadian Territory, which, during the Year in question, is greater than ***
and less than or equal to ***; and
E equals *** of that portion of aggregate Net Sales of Product in the
Canadian Territory, which, during the Year in question, is greater than
***."
11. Clause 11.12 of the License is amended to include a new section (iii)
following the definition of Endo Developed MAM Trade Marks; as follows:
"(iii) the Canadian Trademark, the Endo Developed MAM Trade Marks and
Canadian Trademark together referred to as the "Endo Developed MAM/Canadian
Trade Marks.
All subsequent references to the "Endo-Developed MAM Trade Marks" shall be
substituted by the "Endo-Developed MAM / Canadian Trade Marks."
12. Clause 13.1 of the Licence is deleted in its entirety and replaced with the
following (emphasis added to reflect the changes made in this Second
Amendment):
"The Product for the indication of migraine existing at the Closing Date
shall be promoted, advertised and sold in the Territory under and using the
Vernalis Trade Marks and the ENDO name, xxxx and associated logo (or
successor xxxx or logo), save in respect of the Canadian Territory, where
such Product shall be promoted, advertised and sold under and using the
Canadian Trademark and the ENDO name, xxxx and associated logo (or
successor xxxx or logo). Endo shall use the symbol "(R)" in conjunction
with the Registered Trade Marks. If at any time Endo decides that it wishes
to use a trade xxxx other than the Vernalis Trade Marks, the Canadian
Trademark and the ENDO name, xxxx and associated logo (or successor
thereto) in relation to the MAM Product in the Territory or in relation to
Product for any indication other than the indication of migraine existing
at the Closing Date or in relation to a Combination Product or a Product
Enhancement, Endo shall give written notice to Vernalis specifying the
proposed trade xxxx. Endo shall make filings for proposed trade xxxx in
respect of Product in the countries of the Territory."
13. Clause 18.1 shall be amended to include an additional clause 18.1.7.1 as
follows:
"transfer to Vernalis the Canadian Trademark and all goodwill arising from
use of the Canadian Trademark in the Territory."
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14. All other terms and conditions of the License remain in full force and
effect as originally written therein.
IN WITNESS WHEREOF, the parties have duly executed this First Amendment as
of the first date written above.
ENDO PHARMACEUTICALS INC.
By: /s/ XXXXX XXXXXX
------------------------------------
Name: Xxxxx Xxxxxx
Title: President and CEO
VERNALIS DEVELOPMENT LTD.
By: /s/ XXXX A. D. XXXXXX
------------------------------------
Name: Xxxx A D Xxxxxx
Title: Director
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