EXHIBIT 4.3(G)
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 ***.
FIRST AMENDMENT TO THE CO-PROMOTION AGREEMENT BETWEEN
VERNALIS DEVELOPMENT LIMITED
AND
ENDO PHARMACEUTICALS INC.
DATED JULY 1, 2005
This First Amendment to the Co-Promotion Agreement by and between Vernalis
Development Limited ("Vernalis") and Endo Pharmaceuticals Inc. ("Endo") (the
"First Amendment") is effective as of December 12, 2005.
WHEREAS, Vernalis and Endo entered into a Co-Promotion Agreement dated July 1,
2005 (the "Co-Promotion Agreement"), governing the terms under which Endo and
Vernalis would work together to promote the Product in the USA; and
WHEREAS, Vernalis and Endo wish to amend the Co-Promotion Agreement as more
fully set forth below;
NOW THEREFORE, for good and valuable consideration, the receipt of which is
hereby acknowledged, the parties hereto agree to amend the Co-Promotion
Agreement as follows:
1. Unless set forth herein, the capitalized terms contained in this First
Amendment shall have the meanings set forth in the Co-Promotion Agreement.
2. The following Definition is hereby added to Section 1:
"Tertiary Detail" means a Product Detail presented with lesser prominence
than a Secondary Detail but more prominence than mere inclusion in a
product list.
3. The following is inserted between "not" and "(x)" in Section 2.1(b):
"as determined by reference to the process set out in Section 2.1(c)".
4. The following is added to the Co-Promotion Agreement as Section 2.1(c):
"(c) Process for determining Non-Compete Obligations:
To assist the parties in determining which products fall under the
non-compete provisions set forth in Section 2.1(b), it is agreed that:
(i) Endo shall provide to Vernalis an initial and updated summaries
of all Endo's products either marketed in the USA or under
development that have successfully completed clinical proof of
principle as at the date of each
summary. Such summaries shall include at least: (a) the name of
the product (if marketed) and the class of the molecule and (b)
the indication or indications for which the product is being
marketed or developed (the "Non-compete Summary").
Endo shall provide a Non-compete Summary to Vernalis at the
following times:
(A) within *** business days of the date of this First
Amendment.
(B) no later than *** business days following March 1 and
September 1 of each calendar year during the term of the
Co-Promotion Agreement.
(C) additionally at any time within *** business days of any
request by Vernalis but not more than once during any period
March 1 - August 31 or September 1 - February 29 in any
year.
(ii) Each updated Non-compete Summary shall supercede all previous
Non-compete Summaries other than with respect to the provisions
of Section 2.1 (c) (vi) (B).
(iii) In the event Endo fails to provide to Vernalis a Non-compete
Summary by any due date provided in Section 2.1 (c) (i) (B) or
(C), Endo may not provide a Non-compete Summary to Vernalis
(unless subsequently requested by Vernalis under Section 2.1 (c)
(i) (C)) until the next scheduled due date under Section 2.1 (c)
(i) (B) and the last issued Non-Compete Summary shall continue to
govern until such time.
(iv) On any date that Endo publicly announces an acquisition (via
license, purchase or otherwise) of a product which has
successfully completed clinical proof of principle for any
indication(s), such product and indication(s) shall automatically
be deemed to be included on the most recent Non-compete Summary
as of the date of such public announcement.
(v) Save as provided in Section 2.1 (c) (vi) Vernalis may not use the
Specialty Sales Personnel to Commercialise in the USA any product
for any indication which is in direct competition with an Endo
product and its applicable indication for so long as such product
and indication is included on a Non-compete Summary provided by
Endo under Section 2.1 (c) (i) (A), (B) or (C), or deemed to be
included on a Non-compete Summary pursuant to Section 2.1 (c)
(iv).
(vi) Notwithstanding anything herein to the contrary, Vernalis shall
not be prohibited at any time from using the Specialty Sales
Personnel to Commercialise in the USA any product for which
rights to Commercialise were acquired by Vernalis:
(A) prior to receipt from Endo of any Non-compete Summary which
listed an Endo product and applicable indication with which
Vernalis' product is in direct competition.
(B) within six (6) months following Vernalis' receipt of a
Non-compete Summary under Section 2.1 (c) (i) (C) provided
that the Non-compete Summary did not list an Endo product
and applicable indication with which Vernalis' product is in
direct competition. This shall apply regardless of any
updated Non-compete Summary provided to Vernalis
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by Endo under Section 2.1 (c) (i) (B) before expiry of this
six (6) month period.
By way of example, if Endo provides to Vernalis a
Non-compete Summary under Section 2.1 (c) (i) (C) on August
15, 2006 which does not include a product and applicable
indication which is in direct competition with Product X,
Vernalis may use the Specialty Sales Personnel to
Commercialise Product X in the USA if Vernalis enters into
an agreement with a third party for such rights to Product X
before February 16, 2007 and this shall apply even if an
Endo product in direct competition with Product X is listed
on the updated Non-compete Summary provided by Endo under
Section 2.1 (c) (i) (B) on September 1, 2006.
(vii) At no time is Vernalis prohibited from using sales
representatives other than the Specialty Sales Personnel to
Commercialise any product in the USA whether or not such product
is in direct competition with an Endo product for an indication
listed on a Non-compete Summary then in effect.
5. Section 3.1(a) is amended to add the following phrase to the end of the
last sentence in such section:
"; provided that (i) at least *** Product Details made by Vernalis shall be
Primary Details and (ii) no more than *** Product Details made by Vernalis
shall be Tertiary Details."
6. The following sentences shall be added after the second sentence in Section
3.3(b)(iii):
"In the event that Vernalis fails to provide at least *** Primary Details
and/or provides more than *** Tertiary Details as set forth in Section
3.1(a) in any two consecutive quarters, Endo shall, as applicable, (i)
reduce the reimbursement payment to Vernalis in such second quarter by the
number of Primary Details that fell short of the *** requirement in the
second quarter multiplied by the Cost Per Detail and/or (ii) not reimburse
Vernalis the Cost Per Detail for any Tertiary Detail that exceeded the ***
requirement in the second quarter. Until Vernalis remedies the deficiencies
set forth in this Section 3.3(b)(iii), Endo may continue to reduce
reimbursement payments in accordance with the provisions of this Section
3.3(b)(iii) for each consecutive quarter that the deficiencies continue."
7. The table in Section 3.3(b)(iii) is hereby deleted and replaced with the
following to reflect the amendment to the License as of the date hereof:
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
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8. Exhibit A to the Co-Promotion Agreement is hereby deleted in its entirety
and replaced with the attached Exhibit A.
9. Save as herein provided, all other terms and conditions of the Co-Promotion
Agreement 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/ ▇▇▇▇▇ ▇▇▇▇▇▇
------------------------------------
Name: ▇▇▇▇▇ ▇▇▇▇▇▇
Title: President and CEO
VERNALIS DEVELOPMENT LTD.
By: /s/ ▇▇▇▇ A. D. ▇▇▇▇▇▇
------------------------------------
Name: ▇▇▇▇ A D ▇▇▇▇▇▇
Title: Director
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Exhibit A
Example of Vernalis Detail Report
DETAIL REPORT FOR QUARTER ENDED ____________
THIS IS AN INVOICE
ACTUAL # BUDGET #
-------- --------
Total number of Product Details
Total number of Neurology Details
Total number of Neurology Details to
Target Healthcare Professionals:
Primary Details
Secondary Details
Tertiary Details
Total number of Primary Care Physician
Details
Total number of Primary Care Physician
Details to Target Healthcare
Professionals:
Primary Details
Secondary Details
Tertiary Details
Total number of OBGYN Details
Total number of OBGYN Details to Target
Healthcare Professionals:
Primary Details
Secondary Details
Tertiary Details