EX-10.48.3



 






Exhibit 10.48.3





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





EXECUTION
COPY


 









 






	 	 	 	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





2









 





	 	 	 	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
	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**
	 





3









 







	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/  PETER LANKAU
 	 
	 	 	Name:  	Peter Lankau 	 
	 	 	Title:  	President and CEO 	 
	 



	 	 	 	 	 
	 	VERNALIS DEVELOPMENT LTD.

 	 
	 	By:  	/s/ JOHN A. D. SLATER
 	 
	 	 	Name:  	John A D Slater 	 
	 	 	Title:  	Director 	 



4









 






	 	 	 	 	 



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