EXHIBIT 10.36.2

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
IS

FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE

SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

 

February 13, 2009

 

Mr. Simon Bicknell

Company Secretary

Glaxo Group Limited

Glaxo Wellcome House

Berkeley Avenue

Greenford, Middlesex, UB6 0NN

UNITED KINGDOM

 

Re:

Second Amendment to Development and Commercialization Agreement between
XenoPort, Inc. (“XenoPort”) and Glaxo Group Limited (“GSK”) dated February 7,
2007, as amended by that certain First Amendment, dated May 4, 2007 (as amended
to date, the “Agreement”)

Dear Mr. Bicknell:

This letter (the “Second Amendment”) is to confirm the agreement between
XenoPort and GSK with respect to an amendment to the Agreement as set out in
Paragraphs 1 – 16 below. All capitalized terms not otherwise defined in this
Second Amendment shall have the respective meanings given to such terms in the
Agreement. XenoPort and GSK agree that, effective February 13, 2009 (the “Second
Amendment Date”), the Agreement shall be further amended as follows:

1.        Section 1.17 shall be deleted and restated in its entirety as follows:

“1.17    “Detail” (including any variations such as “Detailing”) shall mean that
part of the activity undertaken by a Sales Representative during a Call whereby
a Sales Representative, who has been trained with respect to the REQUIP™ Product
and/or the Product, as applicable, in accordance with Section 5.4(c), makes a
face-to-face presentation: (a) describing [… * …] as applicable; (b) which may
also include [… * …]; and (c) in accordance with the [… * …], as applicable.
[… * …], shall not constitute a Detail. [… * …], as applicable, shall not
constitute a Detail. Only [… * …] will constitute [… * …]. As used herein, a
[… * …] in which [… * …] (as consistent with industry norms [… * …], and a
[… * …].”

2.      New Section 1.28 shall be added to the Agreement as follows (and all
subsequent definitions in Section 1 and related section references shall be
deemed renumbered accordingly):

 

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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“1.28    “Loss of Exclusivity Date” shall mean the earliest of: (a) [… * …];
(b) [… * …]; and (c) the date that the REQUIP™ Product is withdrawn from the
United States market. The term [… * …].”

3.        Section 1.48 of the Agreement (formerly Section 1.47) shall be deleted
and restated in its entirety as follows:

“1.48    “REQUIP™ Product” shall mean that certain pharmaceutical product
Controlled by GSK or its Affiliates as of the Effective Date, which contains
ropinirole HCL as an active ingredient and is known as of the Second Amendment
Date as REQUIP™ XL.”

(a) All references to “REQUIP™ Products” in Sections 1.4 “Applicable Commercial
Practices Policies,” 1.17 “Detail,” 1.45 (formerly 1.44) “Promotional
Materials,” 1.51 (formerly 1.50) “Sales Representative,” 1.52 (formerly 1.51)
“Samples,” 1.54 (formerly 1.53) “Target Audience,” 5.3, , 5.3(c), 5.3(e),
5.3(e)(i-vii), 5.4(a), 5.4(b), 5.4(c), 5.4(g), 5.4(j), 5.5. 5.6(c), 5.7(a),
5.9(a), 5.9(b)(iii), 5.9(d), 5.9(e), 5.9(f), 9.1(b), 15.2(i), 17.1 and Exhibit 5
of the Agreement shall be replaced with the words “REQUIP™ Product” in each such
Section.

4.        Section 1.49 of the Agreement (formerly Section 1.48) shall be deleted
and restated in its entirety as follows:

“1.49    “REQUIP™ Trademark” shall mean the Trademark Controlled by GSK or its
Affiliates as of the Effective Date and during the Term, which is used with the
REQUIP™ Product in the Field in the Territory.”

(a) All references to “REQUIP™ Trademarks” in Exhibit 5 of the Agreement shall
be replaced with the words “REQUIP™ Trademark.”

5.        All references to “Exhibit 1.59” in Section 1.60 “XenoPort Patents”
(formerly Section 1.59) and Exhibit 1.59 of the Agreement shall be replaced with
the words “Exhibit 1.60” in each such Section.

6.        All references to “Exhibit 1.60” in Section 1.61 “XenoPort Trademarks”
(formerly Section 1.60) and Exhibit 1.60 of the Agreement shall be replaced with
the words “Exhibit 1.61” in each such Section.

7.        A reference to “REQUIP™ Co-Promotion Date” as defined in
Section 5.3(a) shall be added to the Additional Definitions set forth in
Section 1.62 (formerly Section 1.61). A reference to “REQUIP™ Option” as defined
in Section 5.3(a) shall be added to the Additional Definitions set forth in
Section 1.62. References to “Primary Detail” and “Secondary Detail” as defined
in Section 1.17 shall be added to the Additional Definitions set forth in
Section 1.62.

8.        The second sentence of Section 5.2(b) of the Agreement shall be
deleted and restated in its entirety as follows:

“The Co-Promotion Plan shall set out in reasonable detail: (i) [… * …] in
connection with the Co-Promotion [… * …]; (ii) [… * …]; (iii) [… * …]; and
(iv) [… * …].”

9.        The first two sentences of Section 5.2(e) of the Agreement shall be
deleted and restated in their respective entireties as follows:

 

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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“(e)        Sales Effort of XenoPort.    In the event that XenoPort has
exercised the Co-Promotion Option, then upon the earlier to occur of the REQUIP™
Co-Promotion Date and the date the Product receives Marketing Approval in the
United States, XenoPort shall notify GSK of the number of Sales Representatives
that XenoPort elects to deploy initially for the Product, provided that [… * …].
Promptly after such notification, [… * …], XenoPort will [… * …] of Sales
Representatives that XenoPort so elects; [… * …] of Sales Representatives to
provide Details of the Product in accordance with the Co-Promotion Plan.”

10.        Sections 5.3(a), 5.3(b) and 5.3(d) of the Agreement shall be deleted
and restated in their respective entireties as follows:

“(a)        Commencement of Right to Detail the REQUIP™ Product.    If XenoPort
exercises the Co-Promotion Option for the Product, XenoPort shall also obtain a
non-sublicensable, non-exclusive option to Detail the REQUIP™ Product in the
United States in accordance with the terms of this Article 5 (the “REQUIP™
Option”). XenoPort may exercise the REQUIP™ Option by notifying GSK in writing
[… * …] (the date on which XenoPort notifies GSK of its election to exercise the
REQUIP™ Option pursuant to this Section 5.3(a) shall be the “REQUIP™
Co-Promotion Date”). In the event that XenoPort exercises the REQUIP™ Option as
provided in this Section 5.3(a), XenoPort will have a non-exclusive,
non-sublisenable right to Detail the REQUIP™ Product in accordance with the
terms of this Article 5 in the United States until [… * …]; provided, however,
that [… * …]. In the event that XenoPort does not exercise the REQUIP™ Option as
provided in this Section 5.3(a) prior to [… * …], XenoPort will have no right to
Detail the REQUIP™ Product in the United States, and GSK will have no further
obligation with respect to the REQUIP™ Option.

(b)        The REQUIP™ Sales Plan.    GSK shall prepare and determine, in
consultation with XenoPort, the tactical plan for XenoPort’s Detailing of the
REQUIP™ Product by XenoPort Sales Representatives in the United States (the
“REQUIP™ Sales Plan”) and shall provide the REQUIP™ Sales Plan to XenoPort
[… * …]. The REQUIP™ Sales Plan shall set out in reasonable detail: (i) [… * …]
in connection with [… * …]; and (iii) [… * …] under such REQUIP™ Sales Plan,
[… * …] and which is [… * …]. XenoPort shall be entitled to dedicate a number of
Sales Representatives elected by XenoPort, up to [… * …], to Detail the REQUIP™
Product in the United States. XenoPort’s right to deploy such Sales
Representatives shall commence [… * …].”

“(d)        Reimbursement.    GSK shall reimburse XenoPort for each Detail
provided by the XenoPort Sales Representatives Detailing the REQUIP™ Product in
the United States in accordance with the REQUIP™ Sales Plan. Such reimbursement
shall be equal to [… * …]; provided, however that if during the Call in which
the XenoPort Sales Representative is Detailing the REQUIP™ Product, the XenoPort
Sales Representative is Detailing a pharmaceutical product other than the
Product or the REQUIP™ Product, then GSK shall reimburse XenoPort [… * …]. For
the purposes of example only:

(A)        If, during a Call, a XenoPort Sales Representative is only Detailing
the REQUIP™ Product, then XenoPort will be entitled to receive $[… * …] for such
Detail.

 

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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(B)        If, during a Call, a XenoPort Sales Representative is only Detailing
the REQUIP™ Product and the Product, then XenoPort will be entitled to receive
$[… * …] for such Detail of the REQUIP™ Product and $[… * …] for such Detail of
the Product.

(C)        If, during a Call, a XenoPort Sales Representative is Detailing the
REQUIP™ Product, Product and another pharmaceutical product, then XenoPort will
be entitled to receive $[… * …] for such Detail of the REQUIP™ Product and
$[… * …] for such Detail of the Product.

Such reimbursements shall be made to XenoPort [… * …].”

11.        Section 5.4(d) of the Agreement shall be deleted and restated in its
entirety as follows:

“(d)        Timing.    XenoPort and GSK shall cooperate to have the XenoPort
Sales Representatives hired and trained as provided in this Agreement [… * …]
prior to [… * …].”

12.        Section 5.8 of the Agreement shall be deleted and restated in its
entirety as follows:

“5.8        Reimbursement.    Within [… * …], XenoPort shall submit to GSK a
report containing an accounting of the Sales Representatives deployed by
XenoPort in Co-Promoting and Detailing the Product and/or Detailing the REQUIP™
Product (as the case may be) in the United States and [… * …]. Such
reimbursements shall be made to XenoPort [… * …]. The amount of such
reimbursement shall be as specified in Section 5.2(f) and/or 5.3(d), as
applicable.”

13.        Sections 5.9(b)(i), 5.9(b)(ii) and 5.9(c) of the Agreement shall be
deleted and restated in their respective entireties as follows:

“(b)(i)    As to the Product.    After XenoPort has commenced its Detailing of
the Product, GSK shall have the right to terminate XenoPort’s right to
Co-Promote and Detail the Product: (A) [… * …] in accordance with the
Co-Promotion Plan) [… * …]; and/or (B) [… * …] with respect to [… * …].

(ii)        As to the REQUIP™ Product.    After XenoPort has exercised the
Co-Promotion Option and following [… * …], GSK shall have the right to [… * …]
terminate XenoPort’s right to Detail the REQUIP™ Product upon [… * …].”

“(c)        Extension of the REQUIP™ Product Detailing.    GSK shall notify
XenoPort in writing, [… * …], as to whether GSK, in its sole discretion, elects
to extend XenoPort’s right to Detail the REQUIP™ Product after the [… * …] If
GSK so notifies XenoPort of such extension, XenoPort’s right to Detail the
REQUIP™ Product will continue after the [… * …].”

14.        The Milestone Event described in number 7 of Section 6.2(a) of the
Agreement shall be deleted and restated in its entirety as follows:

“7. [… * …]”

 

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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15.        All references to “Section 1.33” in Section 6.3(c) and 18.2 of the
Agreement shall be replaced with the words “Section 1.34” in each such Section.

16.        Section 8.2 of the Agreement shall be deleted and restated in its
entirety as follows:

“8.2        Diligent Efforts of XenoPort.    XenoPort shall use Commercially
Reasonable Efforts to conduct the Clinical Studies and Activities and, in the
event that it exercises the Co-Promotion Option and/or the REQUIP™ Option, as
applicable, use Commercially Reasonable Efforts in its Co-Promotion and
Detailing of the Product and/or Detailing of the REQUIP™ Product, as applicable,
following the Marketing Approval of the Product in the United States and/or the
REQUIP™ Co-Promotion Date, as applicable.”

Except as specifically provided in this Second Amendment, no provision of the
Agreement shall be modified or amended hereby and all provisions of the
Agreement shall remain in full force and effect. The Agreement, as specifically
modified and amended by this Second Amendment, is hereby confirmed and approved.
This Second Amendment and all questions regarding its validity or interpretation
shall be governed by, and construed and enforced in accordance with, the laws of
the State of Delaware, without reference to conflict of law principles.

 

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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Please confirm GSK’s acceptance of, and agreement with, this Second Amendment by
signing, or having an authorized representative of GSK sign, two (2) copies of
this Second Amendment and return one (1) original copy and one (1) photocopy of
the Second Amendment to:

 

 

Originally executed copy to:

 

XenoPort, Inc.

3410 Central Expressway

Santa Clara, CA 95051

Facsimile: (408) 616-7211

Attention: Secretary

  

And a copy to:

 

Wilson, Sonsini, Goodrich & Rosati

650 Page Mill Road

Palo Alto, CA 94304

Facsimile: (650) 493-6811

Attention: Kenneth A. Clark

Yours sincerely,

 

/s/ William J. Rieflin

William J. Rieflin

President

 

 

ACKNOWLEDGED AND AGREED BY GLAXO GROUP LIMITED:

/s/ Paul Williamson

Name:

 

Paul Williamson

Title:  

For and on behalf of Edinburgh Pharmaceutical Industries Limited

   

Corporate Director

Date:     

 

cc:

Adrian Rawcliffe

Senior Vice President, Worldwide Business Development, GlaxoSmithKline

 

cc:

Chip Cale

Vice President and Associate General Counsel, Business Development Transactions,
GlaxoSmithKline

 

 

 

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.