Document:

EX-10.48.2

 

Exhibit 10.48.2

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, mark 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 mark ENDO and the associated Endo logo, (ii) the
Canadian Trademark and (iii) any other trade marks other than the

EXECUTION COPY

 

 

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 1st 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:”

2

 

	 	 	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

3

 

	 	 	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, mark and associated logo (or successor mark 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, mark and associated logo (or successor mark or logo).
Endo shall use the symbol “®” in conjunction with the Registered Trade Marks. If at any
time Endo decides that it wishes to use a trade mark other than the Vernalis Trade Marks,
the Canadian Trademark and the ENDO name, mark 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 mark. Endo shall make filings for proposed trade
mark 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.”

4

 

	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/ 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

5EX-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

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

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

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