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Exhibit 10.54
BOTOX(R) GLOBAL STRATEGIC SUPPORT AGREEMENT
BY AND BETWEEN
GLAXO GROUP LIMITED,
ALLERGAN, INC.
AND
ALLERGAN SALES, LLC
SEPTEMBER 30, 2005
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BOTOX(R) GLOBAL STRATEGIC SUPPORT AGREEMENT
THIS BOTOX(R)
GLOBAL STRATEGIC SUPPORT AGREEMENT, including the exhibits
referred to herein and attached hereto
(collectively, the "AGREEMENT") is made
and entered into effective as of September
30, 2005 (the "EFFECTIVE DATE"), by
and between ALLERGAN, INC., a Delaware
corporation, having its principal place
of business at 2525 Dupont Drive, Irvine,
California 92612, U.S.A., ALLERGAN
SALES, LLC, a Delaware limited liability
company, having its principal place of
business at 2525 Dupont Drive, Irvine,
California 92612, U.S.A. (ALLERGAN, INC.
and ALLERGAN SALES, LLC are collectively
referred to herein as "ALLERGAN") and
GLAXO GROUP LIMITED, a private limited
company incorporated in England and
Wales, having its registered office at
Glaxo Wellcome House, Berkeley Avenue,
Greenford, Middlesex, England UB6 0NN
("GSK").
RECITALS
WHEREAS,
ALLERGAN and GSK desire to build the image, awareness and
effectiveness of the BOTOX(R) brand in the
Territory (as defined below).
NOW, THEREFORE,
in consideration of the mutual covenants and obligations
set forth herein, and for other good and
valuable consideration, the receipt and
sufficiency of which is hereby
acknowledged, ALLERGAN and GSK hereby agree as
follows:
AGREEMENT
1. DEFINITIONS
1.1 "AFFILIATE"
of a Party or Person means any Person, whether de jure or
de facto, that directly or indirectly,
controls, is controlled by, or is under
common control with such Party or Person,
as applicable. Solely as used in this
definition, "control" means (a) direct or
indirect ownership of more than fifty
percent (50%) of the equity (or such lesser
percentage which is the maximum
allowed to be owned by a foreign
corporation in a particular jurisdiction)
having the power to vote on or direct the
affairs of such Party or Person, as
applicable, or (b) the possession, directly
or indirectly, of the power to
direct or cause the direction of the
policies and management of such Party or
Person, as applicable, whether by the
ownership of stock, by contract, or
otherwise.
1.2 "AGREEMENT"
will have the meaning set forth in the Preamble.
1.3 "ALLERGAN"
will have the meaning set forth in the Preamble.
1.4 "APPLICABLE
LAW" means all applicable provisions of any and all
federal, national, state, provincial, and
local statutes, laws, rules,
regulations, administrative codes,
ordinances, decrees, orders, decisions,
injunctions, awards, judgments, permits and
licenses of or from any governmental
authorities relating to or governing the
use or regulation of the subject item
or action.
*** Certain confidential information
contained in this document, marked with 3
asterisks, has
been omitted and filed separately with the Securities and
Exchange
Commission pursuant to Rule 24b-2 of the Securities Act of
1934,
as amended.
1
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1.5 "BOTOX"
means any pharmaceutical composition intended for
administration to humans containing
botulinum toxin type A, regardless of
formulation, dosage, or form, which is
marketed by ALLERGAN or GSK under the
BOTOX trademark.
1.6 "CALENDAR
YEAR" means, for the first Calendar Year, the period
beginning on the Execution Date and ending
December 31, 2005, and for each
Calendar Year thereafter, each successive
period beginning on January 1 and
ending twelve (12) consecutive calendar
months later on December 31; provided
however, that the last Calendar Year of the
Term may be for a term of less than
twelve (12) consecutive months.
1.7 "EFFECTIVE
DATE" will have the meaning set forth in the Preamble.
1.8 "GLOBAL
MARKETING" means ALLERGAN's BOTOX Global Strategic Marketing
team, which is responsible for determining
long-term strategy, competitor and
trademark defense, global market research
strategy, commercial assessment and
guidance of development projects, global
publicity strategy, medical marketing
prioritization, publications and other
strategic communications for BOTOX.
1.9 "GSK" will
have the meaning set forth in the Preamble.
1.10 "PARTY"
means either GSK or ALLERGAN and "Parties means both of them.
1.11 "PERSON"
means an individual, corporation, partnership, association,
trust or any other entity or organization,
including, without limitation any
government or political subdivision or any
agency or instrumentality thereof.
1.12
"SEMI-ANNUAL PROGRESS REPORT" will have the meaning set forth
in
Section 2.2.
1.13 "SUPPORT
SERVICES" will have the meaning set forth in Section 2.1.
1.14 "TERM" will
have the meaning set forth in Section 6.1.
1.15 "TERRITORY"
means Japan and the Peoples Republic of China, and their
respective territories and possessions;
provided, however that Territory does
not include Hong Kong or Taiwan.
1.16 "THIRD
PARTY" means any Person other than ALLERGAN or GSK or either of
their respective Affiliates.
2. SUPPORT ACTIVITIES
2.1 General.
ALLERGAN's objectives under this Agreement will be to (i)
assist GSK to develop scientifically
differentiated and customer-responsive
promotional platforms and provide proactive
strategic guidance to augment
development of effective promotional and
medical education efforts for BOTOX in
the Territory, (ii) review whether tactical
plans for BOTOX in the Territory
achieve consistency with worldwide BOTOX
strategies, and (iii) assist GSK to
maintain synergy and/or best practices with
respect to BOTOX marketing in the
Territory. In furtherance of
*** Certain confidential information
contained in this document, marked with 3
asterisks, has
been omitted and filed separately with the Securities and
Exchange
Commission pursuant to Rule 24b-2 of the Securities Act of
1934,
as amended.
2
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these objectives, during the Term and
subject to the terms and conditions of
this Agreement, ALLERGAN or its Affiliates
will use commercially reasonable
efforts to conduct the specific activities
and deliver the deliverables set
forth on Exhibit A with respect to BOTOX
(the "SUPPORT SERVICES").
2.2 Semi-Annual
Reports. Not later than July 31 and January 31 of each
Calendar Year, ALLERGAN will provide GSK
with a written report detailing the
Support Services performed by ALLERGAN or
its Affiliate during the immediately
preceding six (6) month period ending June
30 and December 31, respectively, and
the Support Services planned for the
immediately succeeding (6) month periods,
including at a minimum a summary of the
progress towards completion of the
Support Services ("SEMI-ANNUAL PROGRESS
REPORTS").
2.3. No Asset
Transfer. Nothing in this Agreement will be construed as an
assignment, license or other transfer of
ownership of any kind by either Party
of such Party's (or its Affiliates')
intellectual property or other intangibles.
2.4 Lead
Contact. Each Party will appoint a lead contact to coordinate
and
manage the Support Services ("LEAD
CONTACT"). The Lead Contact for each Party
will be identified to the other Parties
within ten (10) calendar days after the
Effective Date. Either Party may change its
Lead Contact upon written notice to
the other Party.
3. SUPPORT PAYMENTS
3.1 Semi-annual
Payments. In consideration for ALLERGAN's provision of the
Support Services as provided in this
Agreement and subject to Sections 3.3, 3.4
and 3.5, GSK shall pay ALLERGAN in arrears
on an semi-annual basis the amount
for such Calendar Year set forth in Exhibit
B. Such amounts shall be paid by GSK
within forty-five (45) calendar days of
GSK's receipt of the Semi-Annual
Progress Report and an invoice referring to
this Support Agreement and
specifying the amount due; provided,
however, that the final semi-annual payment
shall be due on the expiration date of
Term.
3.2 Records;
Audit Right. ALLERGAN shall maintain records sufficient to
enable accurate calculation of the costs
and expenses incurred by ALLERGAN in
providing the Support Services. ALLERGAN
shall permit an independent public
accountant designated by GSK and reasonably
acceptable to ALLERGAN, to have
access, no more than once in each Calendar
Year during the Term and no more than
once following the expiration or
termination of the Term, during regular
business hours and upon at least thirty
(30) days' written notice, to examine in
confidence ALLERGAN's records solely to the
extent necessary to determine that
*** with respect to such Calendar Year. The
independent public accountant shall
not report to GSK anything other than
whether *** with respect to such Calendar
Year. The costs and expense incurred by
ALLERGAN in providing the Support
Services shall not be otherwise subject to
audit or review by GSK or to any
report by the independent public accountant
performing any audit or review
permitted by this Section. The costs of
such review or audit shall be at GSK's
expense.
*** Certain confidential information
contained in this document, marked with 3
asterisks, has
been omitted and filed separately with the Securities and
Exchange
Commission pursuant to Rule 24b-2 of the Securities Act of
1934,
as amended.
3
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3.3 Performance
Condition. GSK's obligation to pay ALLERGAN as provided in
Section 3.1 is subject to ALLERGAN (i)
submitting the Semi-Annual Progress
Reports as provided in Section 2.2 that
provide evidence to GSK that the Support
Services outlined on Exhibit A have been
performed within the time periods set
forth on Exhibit A and (ii) for the payment
to be made for the first half of any
Calendar Year, submitting a letter from
ALLERGAN's Lead Contact confirming that
*** with respect to such period, and for
the payment to be made at the end of
any Calendar Year, a letter from ALLERGAN's
Lead Contact confirming that ***
with respect to such Calendar Year. If the
foregoing documents are delivered
evidencing that the Support Services have
been performed from semi-annual period
to semi-annual period as set forth and in
accordance with the time periods set
forth in the Semi-Annual Progress Reports,
ALLERGAN will have met its
performance condition.
3.4 Taxes. To
the extent a statutory tax withholding obligation is imposed
by a governmental authority upon any
payment due and payable by GSK to ALLERGAN
under the terms and conditions of this
Agreement, GSK will be entitled to
withhold from such payment the amount, if
any, of any tax assessed against
ALLERGAN and actually withheld, provided
that such tax is only for the account
of ALLERGAN and evidence of the payment of
such tax is promptly provided to
ALLERGAN. GSK will pay the amount of such
tax to the proper taxing authority and
will be entitled to deduct the amount of
such tax from the payment to be made by
GSK to ALLERGAN. GSK will advise ALLERGAN
of any tax payment made for the
benefit of ALLERGAN pursuant to this
Section 3.4 and provide ALLERGAN copies of
tax receipts for all taxes paid and
deducted from the payment due and payable to
ALLERGAN, together with copies of all
pertinent communications from or with
governmental authorities with respect
thereto. At ALLERGAN's reasonable request
and subject to ALLERGAN reimbursing any
costs and expenses, GSK will reasonably
assist ALLERGAN in any effort by ALLERGAN
in claiming any exemption from such
deductions or withholdings under any double
taxation or similar agreement or
treaty from time to time in force, and in
minimizing the amount required to be
so withheld or deducted. ALLERGAN warrants
that ALLERGAN is resident for tax
purposes in United States of America and
that ALLERGAN is entitled to relief
from United Kingdom income tax under the
terms of the double tax agreement
between the United Kingdom and the United
States of America. ALLERGAN will
notify GSK immediately in writing in the
event that ALLERGAN ceases to be
entitled to such relief. Pending receipt of
formal certification from the United
Kingdom Inland Revenue, GSK may pay any
payments under this Agreement to
ALLERGAN by deducting tax at a rate
specified in the double tax treaty between
the United Kingdom and the United States of
America. ALLERGAN agrees to
indemnify and hold harmless GSK against any
loss, damage, expense, or liability
arising in any way from a breach by
ALLERGAN of the warranties in this Section
3.4 or any future claim by a United Kingdom
tax authority or other similar body
alleging that GSK was not entitled to
deduct such withholding tax on such
payments at source at the treaty rate.
3.5 Payments
Made in U.S. Currency; Wire Transfers. All payments made under
this Agreement will be made in U.S. dollars
and payments made by GSK hereunder
will be made to ALLERGAN by bank wire
transfer in immediately available funds to
ALLERGAN in accordance with the wire
instructions set forth in Exhibit C, which
may be changed only by written notice to
GSK from the Chief Financial Officer of
ALLERGAN in accordance with Section
8.7.
*** Certain confidential information
contained in this document, marked with 3
asterisks, has
been omitted and filed separately with the Securities and
Exchange
Commission pursuant to Rule 24b-2 of the Securities Act of
1934,
as amended.
4
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3.6 Late
Payments. Any payment due and payable under the terms and
conditions of this Agreement made by GSK or
ALLERGAN after the date such payment
is due and payable, will bear interest as
of the day after the date such payment
was due and payable, and will continue to
accrue such interest until such
payment is made, at rate equal to *** per
month. The payment of such interest
will not limit either Party from exercising
any other rights it may have as a
consequence of the lateness of any
payment.
4. REPRESENTATIONS AND
WARRANTIES; RESTRICTIVE COVENANTS
4.1 By ALLERGAN.
ALLERGAN represents and warrants that as of the Effective
Date:
4.1.1 ALLERGAN is a corporation duly organized, validly existing,
and
in good standing under the laws of the
state of Delaware;
4.1.2 The execution, delivery, and performance of this Agreement
by
ALLERGAN have been duly authorized by all
requisite corporate action and do not
require any shareholder action or
approval;
4.1.3 The execution, delivery, and performance by ALLERGAN of
this
Agreement and its compliance with the terms
and provisions hereof do not and
will not conflict with or result in a
breach of any of the terms and provisions
of or constitute a default under (a) any
agreement with a Third Party, including
but not limited to a loan agreement,
guaranty, financing agreement, agreement
affecting a Product, or other agreement or
instrument binding or affecting it or
its property; (b) the provisions of its
charter or operative documents or
bylaws; or (c) any order, writ, injunction,
or decree of any court or
governmental authority entered against it
or by which any of its property is
bound; and
4.1.4 ALLERGAN has the right and authority to provide the
Support
Services to GSK and its Affiliates pursuant
to the terms and conditions set
forth in this Agreement in the
Territory.
4.2 By GSK. GSK
represents and warrants that as of the Effective Date:
4.2.1 GSK is a private limited company duly organized, validly
existing, and in good standing under the
laws England and Wales;
4.2.2 The execution, delivery, and performance of this Agreement
by
GSK has been duly authorized by all
requisite corporate action and does not
require any shareholder action or approval;
and
4.2.3 The execution, delivery, and performance by GSK of this
Agreement and its compliance with the terms
and provisions hereof does not and
will not conflict with or result in a
breach of any of the terms and provisions
of or constitute a default under (a) a loan
agreement, guaranty, financing
agreement, agreement affecting a Product,
or other agreement or instrument
binding or affecting it or its property;
(b) the provisions of its charter or
operative documents or
*** Certain confidential information
contained in this document, marked with 3
asterisks, has
been omitted and filed separately with the Securities and
Exchange
Commission pursuant to Rule 24b-2 of the Securities Act of
1934,
as amended.
5
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bylaws; or (c) any order, writ, injunction,
or decree of any court or
governmental authority entered against it
or by which any of its property is
bound.
4.3 Disclaimer.
THE REPRESENTATIONS AND WARRANTIES SET FORTH IN THIS
ARTICLE 4 ARE THE EXCLUSIVE REPRESENTATIONS
AND WARRANTIES MADE IN OR UNDER THIS
SUPPORT AGREEMENT AND ARE IN LIEU OF ALL
WARRANTIES, EXPRESS, STATUTORY OR
IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE
IMPLIED WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A
PARTICULAR PURPOSE.
4.4 Restrictive
Covenant of GSK.
4.4.1 The Parties acknowledge that:
(a) As of the Effective Date, neither GSK nor its Affiliates
have
any current or future intention of making,
having made, using, offer for sale or
importing a Competing Product (as defined
in Section 4.4.2) in the Field of Use
in any country of the world; and
(b) During the Term, GSK will obtain certain Confidential
Information of ALLERGAN relating to the
development, manufacture and
commercialization of BOTOX, which is
valuable and highly confidential to
ALLERGAN and critical to the competitive
success of ALLERGAN's business
worldwide.
4.4.2 To the extent permitted under Applicable Law, during the
Term
and for a period of *** after the
expiration date of this Agreement or the
effective date of the termination of this
Agreement for any reason other than by
GSK pursuant to Sections 6.3.1 or 6.3.2
(the "RESTRICTIVE PERIOD"), neither GSK
nor any Affiliate of GSK will manufacture,
market, distribute, sell, promote, or
detail any pharmaceutical product in the
Territory, which ***, other than BOTOX
(a "COMPETING PRODUCT") in the Field of
Use; provided, however, that:
(a) If GSK or any of its Affiliates manufactures, initiates
clinical studies, markets, distributes,
sells, promotes, or details
(collectively, "COMMERCIALIZATION") a
Competing Product in *** during the Term,
GSK will (i) notify ALLERGAN immediately
upon becoming aware of such
commercialization, and (ii) cease
commercialization of such Competing Product
within *** after the date that GSK became
aware of such commercialization. If
GSK does not cease such commercialization
within *** after becoming aware of
such commercialization, ALLERGAN, at any
time thereafter, will have a right to
terminate this Agreement or any other
agreement between the Parties relating to
BOTOX in the Territory, which termination
of this Agreement by ALLERGAN will be
deemed a termination by ALLERGAN pursuant
to Section 6.3.1. During the period
between the date that GSK becomes aware of
commercialization of a Competing
Product as provided in this Section
4.4.2(a) and the earlier of the date on
which GSK ceases such commercialization and
the expiration of the Restrictive
Period, GSK will pay to ALLERGAN *** of all
of GSK's or its Affiliates' net
sales of such Competing Product (which net
sales will be calculated in the same
manner that Net Sales of GSK are calculated
herein). Notwithstanding the
foregoing, if GSK or any of its Affiliates
has used ALLERGAN's
*** Certain confidential information
contained in this document, marked with 3
asterisks, has
been omitted and filed separately with the Securities and
Exchange
Commission pursuant to Rule 24b-2 of the Securities Act of
1934,
as amended.
6
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Confidential Information in connection with
the commercialization of a Competing
Product as provided in this Section
4.4.2(a), ALLERGAN will have the right to
immediately terminate this Agreement and
any other agreement between the Parties
relating to BOTOX in the Territory, upon
thirty (30) calendar days' prior
written notice to GSK, which termination of
this Agreement by ALLERGAN will be
deemed a termination by ALLERGAN pursuant
to Section 6.3.1.
(b) Notwithstanding anything contained in this Section 4.4.2,
nothing herein will, expressly or
impliedly, preclude or restrict GSK, or any of
its Affiliates, in any way from (i)
acquiring a majority of the voting stock, or
all or substantially all of the assets of,
a Business Entity (as defined below);
(ii) being acquired by a Business Entity;
or (iii) merging, amalgamating, taking
over, or consolidating (or engaging in any
similar transaction) with a Business
Entity (hereinafter, the actions referred
to in (i), (ii), and (iii) of this
Section 4.4.2(b) are collectively referred
to as "MERGER" or "MERGING").
The term "BUSINESS ENTITY" as used in this Section 4.4.2(b)
means any Person, which, at the time of
such Merger, is commercializing (as such
term is defined in Section 4.4.2(a)) a
Competing Product in ***, including, for
example, the Persons listed on Exhibit
D.
In the event that GSK or any of its Affiliates Merges with a
Business Entity during the Term, GSK will
divest or cause the divestiture of the
Competing Product being commercialized by
the Business Entity within *** after
the date of the public announcement of such
Merger ("MERGER DATE"). During such
*** period, (A) neither GSK nor any of its
Affiliates will use any ALLERGAN
Confidential Information in connection with
the commercialization of such
Competing Product; and (B) GSK will
continue to comply with the terms of this
Agreement in all respects. If GSK does not
divest or cause the divesture of such
Competing Product within *** after the
Merger Date, ALLERGAN, at any time
thereafter, will have a right to terminate
this Agreement and any other
agreement between the Parties relating to
BOTOX in the Territory, which
termination of this Agreement by ALLERGAN
will be deemed a termination by
ALLERGAN pursuant to Section 6.3.1. In the
event that GSK does not divest or
cause the divesture of such Competing
Product within the *** period as provided
in this Section 4.4.2(b), GSK will pay to
ALLERGAN *** of all of GSK's or its
successor's net sales of such Competing
Product after such *** period (which net
sales will be calculated in the same manner
that Net Sales are calculated
herein) and continuing until the earlier of
the date on which GSK or its
successor divests such Competing Product or
the expiration of the Restrictive
Period.
4.5 Restrictive
Covenant of ALLERGAN. In consideration for GSK's agreement
to the terms set forth in Section 4.4
above, ALLERGAN covenants to GSK as
follows:
4.5.1 ALLERGAN will not, and will cause all of its Affiliates
and
sublicensees not to, either on its or their
own or with any Third Party, conduct
any development activities or conduct
clinical trials relating to BOTOX, or seek
any regulatory approvals for BOTOX, in any
country in Territory during the Term,
except as specifically permitted in any
agreements between the Parties relating
to BOTOX in such countries; and
*** Certain confidential information
contained in this document, marked with 3
asterisks, has
been omitted and filed separately with the Securities and
Exchange
Commission pursuant to Rule 24b-2 of the Securities Act of
1934,
as amended.
7
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4.5.2 ALLERGAN will not, and will cause all of its Affiliates
and
sublicensees not to, either on its or their
own or with any Third Party, use,
sell, offer for sale or import BOTOX in any
country in the Territory during the
Term, except, as specifically permitted in
any agreements between the Parties
relating to BOTOX in such countries or as
otherwise authorized by GSK in
writ
