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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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






