Exhibit 10.56
JAPAN BOTOX(R) SUPPLY AGREEMENT
BY AND BETWEEN
GLAXO GROUP LIMITED
AND
ALLERGAN PHARMACEUTICALS IRELAND
SEPTEMBER 30, 0000
XXXXX BOTOX(R) SUPPLY AGREEMENT
THIS JAPAN BOTOX(R) SUPPLY AGREEMENT (this "SUPPLY AGREEMENT") is made and
entered into effective as of September 30, 2005 (the "EFFECTIVE DATE"), by and
between ALLERGAN PHARMACEUTICALS IRELAND, a Cayman Islands corporation, having
its principal place of business at Carrowberg, Xxxxxxxxx Xxxx, Xxxxxxxx, Xxxxxx
Xxxx, Xxxxxxx ("ALLERGAN") and GLAXO GROUP LIMITED, a company incorporated in
England, having its principal place of business at Glaxo Xxxxxxxx Xxxxx,
Xxxxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxx, XX0 0XX, Xxxxxxx ("GSK"). ALLERGAN and
GSK are hereinafter collectively referred to as the "parties" or individually as
a "party."
RECITALS
WHEREAS, Allergan, Inc. and Allergan Sales, LLC, Affiliates of ALLERGAN,
and GSK have entered into a separate License Agreement of even date herewith
pursuant to which GSK and its Affiliates have received, among other things, a
license to import, develop, promote, sell and distribute BOTOX(R) in Japan; and
WHEREAS, Allergan, Inc. and Allergan Sales, LLC agreed in the License
Agreement to procure from ALLERGAN the supply of BOTOX(R)to GSK and its
Affiliates; and
WHEREAS, GSK desires to purchase and ALLERGAN desires to sell to GSK all of
GSK's requirements of BOTOX(R), subject to the terms and conditions set forth
herein.
AGREEMENT
NOW, THEREFORE, in consideration of the mutual covenants and agreements
contained herein and for other good and valuable consideration, the receipt and
adequacy of which are hereby acknowledged, the parties agree as follows:
1. DEFINITIONS
1.1 Active Pharmaceutical Ingredient (API). "Active Pharmaceutical
Ingredient" or "API" means Botulinum Toxin Type A Manufactured by ALLERGAN to
the registered specifications at the API Manufacturing Facilities which is
intended to cause pharmacological activity or other direct effect in the
diagnosis, cure, treatment or prevention of disease or to affect the structure
or function of the body of human or animal.
1.2 Affiliate. An "Affiliate" of a person or entity means any individual,
sole proprietorship, firm, partnership, corporation, trust, joint venture or
other entity, whether de jure or de facto, which, directly or indirectly,
controls, is controlled by or is under common control with such person or
entity. As used in this definition, "control" means the possession, directly or
indirectly, of the power to direct or cause the direction of the policies and
management of a person or entity, whether by the ownership of stock, by contract
or otherwise.
*** 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 Exchange Act
of 1934, as amended.
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1.3 Certificate of Analysis and Compliance. "Certificate of Analysis and
Compliance" means a document in the form set forth in Exhibit A (as may be
changed from time to time with the mutual agreement of the Parties), signed by
ALLERGAN's designated quality manager and provided by ALLERGAN to GSK, that sets
forth the analytical test results against the Specifications for a specified Lot
of Product and that certifies that each batch or Lot of Product was produced and
tested in compliance with the Specifications, cGMPs, the master batch record and
all applicable Marketing Authorizations and Manufacturing Authorizations.
1.4 Change Control. "Change Control" means the process by which changes may
be made to the Product, as set forth in Section 2.5.
1.5 cGMPs. "cGMPs" means all applicable standards relating to manufacturing
practices for fine chemicals, intermediates, bulk products or finished
pharmaceutical products. For purposes of this Supply Agreement, cGMPs shall mean
(i) the principles detailed in the Japanese Pharmaceutical Affairs Law and
Japanese Ministerial Ordinance 136, ICH Q7a, U.S. cGMP 21CFR Parts 210 & 211 and
The Rules Governing Medicinal Products in the European Community, Volume IV Good
Manufacturing Practice for Medicinal Products as each may be amended from time
to time or (ii) legislation or regulations or guidance documents (including but
not limited to advisory opinions, compliance policy guides and guidelines)
promulgated by any Regulatory Authority having jurisdiction over the Manufacture
of the Products, subject to any arrangements, additions or clarifications agreed
to from time to time by the parties.
1.6 For Cause. "For Cause" means (i) an express requirement by the
Regulatory Authority in the Territory to conduct a root cause investigation by
way of an audit or (ii) an adverse event or serious problem in the Territory
that requires a root cause investigation that cannot be finally resolved or
concluded solely by a review of documentation.
1.7 License Agreement. "License Agreement" means the License Agreement for
the Product entered into by GSK and Allergan, Inc. and Allergan Sales, LLC,
relating to the grant of certain rights and licenses under certain intellectual
property for development and/or commercialization of Product in the Territory
entered into on or about the date hereof.
1.8 Lot. "Lot" means each separate and distinct batch or lot of Product
processed under continuous and identical conditions and designated by a unique
batch or lot number and expiration date.
1.9 Manufacture. "Manufacture" or "Manufacturing" means the planning,
purchasing, manufacture, processing, compounding, storage, filling, packaging,
waste disposal, labeling, leafleting, testing, sample retention, stability
testing, release and dispatch of Products and such activities as may be required
for ALLERGAN to manufacture and supply each Product respectively in accordance
with this Supply Agreement.
1.10 Manufacturing Facility. "Manufacturing Facility" or "Manufacturing
Facilities" means ALLERGAN's Westport, Ireland, secondary manufacturing
facility, or such other facility or facilities used by ALLERGAN in the
Manufacture of the Product (including the Active Pharmaceutical Ingredient
facilities), as may be designated from time to time by ALLERGAN in
*** 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 Exchange Act
of 1934, as amended.
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accordance with the Change Control procedure. Throughout this Supply Agreement
the term Manufacturing Facilities means both the secondary manufacturing
facility at Westport and the API manufacturing facilities. Each type of facility
will be referred to separately, as necessary, as the "API Manufacturing
Facility" and the "Secondary Manufacturing Facility".
1.11 Manufacturing Authorization. "Manufacturing Authorization" means, with
respect to the Territory, the regulatory authorization required to Manufacture
the Product and the API at the Manufacturing Facilities as granted by the
relevant Regulatory Authority in the Territory or the country of Manufacture, as
the case may be.
1.12 Marketing Authorization. "Marketing Authorization" means the
approvals, licenses, registrations or authorizations (as may be amended or
updated from time to time), including the Xxxxxx, necessary for GSK to import
and sell the Product in the Territory.
1.13 Materials. "Materials" means the raw materials (including API),
components and other ingredients required to Manufacture the Product, each as
specifically identified in the Marketing Authorization.
1.14 Product. "Product" means finished drug product containing the API and
Manufactured by ALLERGAN to the Specifications for supply to GSK under the terms
of this Supply Agreement.
1.15 Product Change. "Product Change" shall have the meaning set forth in
Section 2.4.
1.16 Quality Obligations. "Quality Obligations" means the additional
quality obligations set out at Exhibit F.
1.17 Regulatory Authority. "Regulatory Authority" means the national,
supranational, regional, state or local regulatory agency, department, bureau,
commission, council or other government entity involved in the granting of
Marketing Authorization for the Product in the Territory or Manufacturing
Authorization for the Product or API in the Territory or the country of
manufacture.
1.18 Specifications. "Specifications" means the specifications for the
Product in finished pack form as approved by the Regulatory Authority in the
Territory and as set forth in the Xxxxxx and the form of Certificate of Analysis
and Compliance.
1.19 Standard Cost. "Standard Cost" means ALLERGAN's internal standard
cost, comprising direct and indirect fully allocated costs to Manufacture
Botulinum Toxin Type A at the Manufacturing Facility for supply to GSK or any of
ALLERGAN's other customers (be they Third Parties or Affiliates), including
without limitation the ***, determined in accordance with applicable law and
U.S. generally accepted accounting principles using methodology consistently
applied by ALLERGAN.
1.20 Term. "Term" shall have the meaning set forth in Section 8.1.
*** 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 Exchange Act
of 1934, as amended.
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1.21 Territory. "Territory" means Japan and its territories and
possessions.
1.22 Third Party. "Third Party" means any person or entity other than
ALLERGAN or GSK or either of their Affiliates.
1.23 Unit. "Unit" shall mean each separate stock keeping unit of Product
with a distinct product number or item code.
1.24 VAT & Indirect Taxes. "VAT & Indirect Taxes." means the tax imposed by
the sixth council directive of the European Community and any national
legislation implementing that directive together with legislation supplemental
thereto and in particular, in relation to the United Kingdom, the tax imposed by
the Value Added Tax Act of 1994 or other tax of a similar nature, including
sales taxes, imposed elsewhere instead of or in addition to value added tax.
2. MANUFACTURE AND SUPPLY
2.1 General. During the Term, and subject to the terms and conditions of
this Supply Agreement, GSK agrees to purchase all of its clinical trial and
commercial requirements of Product for the Territory exclusively from ALLERGAN,
and ALLERGAN agrees to sell to GSK and relevant GSK Affiliates all of GSK's
requirements of Product for the Territory. ALLERGAN shall be the exclusive
supplier of Product to GSK, its Affiliates and any permitted sublicensees or
assignees for the Territory.
2.2 Manufacturing.
(a) ALLERGAN shall only Manufacture the Product at the Secondary
Manufacturing Facilities and the API at the API Manufacturing Facilities. ***,
all Product shall be supplied to GSK from ALLERGAN's Secondary Manufacturing
Facility***. GSK acknowledges that ALLERGAN intends to add, within the next
three years, an additional production line at the Secondary Manufacturing
Facility at Westport, Ireland, ("CORE 3") and an additional API Manufacturing
Facility. If ALLERGAN wishes to change the facility at which ALLERGAN
Manufactures Product or API or add additional facilities at which ALLERGAN
Manufactures Product or API, ALLERGAN shall provide GSK with prior written
notice to that effect in order to allow GSK to comply with its regulatory and
legal obligations and obtain any necessary approvals from a Regulatory Authority
of amendments to Marketing Authorizations in relation to such a change. Any
changes to the Manufacturing Facilities that cause a Product Change will be
dealt with in accordance with the Change Control procedure set out in Section
2.5. Notwithstanding the foregoing, ALLERGAN shall supply GSK with Product
pursuant to Marketing Authorizations for the Territory, and ALLERGAN shall
maintain sufficient supplies of approved Product to supply GSK its requirements
for the Territory until approvals from a Regulatory Authority of amendments to
Marketing Authorization in the Territory is obtained for any changes to the
Manufacturing Facilities. ALLERGAN shall obtain any necessary Manufacturing
Authorizations from the Regulatory Authority in the country of Manufacture prior
to any modifications to the API Manufacturing Facilities or Secondary
Manufacturing Facilities. ALLERGAN will be solely responsible for obtaining
necessary Manufacturing Authorizations in
*** 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 Exchange Act
of 1934, as amended.
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the country of Manufacture for Manufacturing the Product at any Secondary
Manufacturing Facility and the API at any API Manufacturing Facility. GSK shall
obtain (with reasonable assistance from ALLERGAN) any necessary Marketing
Authorizations from the Regulatory Authority in the Territory prior to any
modifications to the API Manufacturing Facilities or Secondary Manufacturing
Facilities. GSK shall be diligent in its efforts to obtain approvals from a
Regulatory Authority of amendments to Marketing Authorizations in the Territory
to any Product Changes, with the support of ALLERGAN, in order to ensure that
ALLERGAN may implement such Product Changes as soon as possible. ALLERGAN shall
be diligent in its efforts to obtain Manufacturing Authorization in the country
of Manufacture to any Product Changes, with the support of GSK, in order to
ensure that ALLERGAN may implement such Product Changes as soon as possible.
(b) ALLERGAN shall be solely responsible for ordering the relevant
quantities of Materials and for the timely delivery of such Materials. ALLERGAN
shall purchase and use only Materials in the Manufacture of the Product which
comply with the requirements of cGMP, the Manufacturing Authorizations and
Marketing Authorization, and which have been tested in accordance with the
Marketing Authorisation and applicable law in the Territory. Any changes to the
suppliers of Materials that cause a Product Change will be dealt with in
accordance with the Change Control procedure set out in Section 2.5. ALLERGAN
shall at all times store and warehouse all Materials and Products Manufactured
by ALLERGAN pursuant to this Supply Agreement in premises that are secure and
clean.
(c) ***.
2.3 Product Packaging & Labeling.
(a) Each Unit of Product will be packaged and labeled by ALLERGAN with
Territory-specific language, indications, labeling and regulatory disclosures in
accordance with the Specifications. The parties shall design the packaging and
labeling, as set out in Section 2.3(b) below, to the greatest extent possible,
to prevent the Product from being distributed and sold outside the Territory.
Each Unit of Product shall bear a label and be contained in an outer package
and/or carton and, if applicable, be accompanied by a package insert, which
label, outer package and/or carton and/or package insert shall comply with all
applicable regulatory requirements in the Territory and shall carry a legend
clearly indicating that the Product was licensed from ALLERGAN.
(b) ALLERGAN and GSK shall jointly design and agree upon any changes
to the packaging and labeling for the Product sold in the Territory, and shall
use reasonable efforts to design such packaging and labeling to prevent the
Product manufactured for sale in the Territory from being distributed and sold
outside the Territory. If either party desires to change the packaging or
labeling for the Product, it shall submit the proposed change to the other party
for review and approval. The party receiving the proposed change shall promptly
review the proposal and respond in writing with its approval or disapproval
(together with its reasons for such disapproval). Any disputes regarding the
design of labeling or packaging shall be resolved in accordance with the dispute
resolution procedures specified in Section 10.9 of this Supply Agreement. GSK
shall be responsible for ensuring that the design of the packaging and labeling
is
*** 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 Exchange Act
of 1934, as amended.
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compliant with applicable law in the Territory. ALLERGAN's review and approval
of the design of any packaging or labeling shall not cause ALLERGAN to be liable
or otherwise responsible for the compliance of the design of the packaging and
labeling with applicable laws, provided that ALLERGAN shall not unreasonably
withhold approval of any design or proposal which is necessary (in GSK's
opinion) for legal or regulatory compliance purposes. For the avoidance of
doubt, nothing in this Section 2.3(b) shall limit or exclude ALLERGAN's
liability attributable to the Manufacture of the Product.
2.4 Product Changes. All modifications to the Product (including changes to
Material suppliers), API, their Specifications or changes to the Manufacturing
process of the Product or API which may effect the legal or regulatory
obligations of GSK in the Territory (including the Marketing Authorizations) or
the Product's quality, efficacy or safety (together known as "PRODUCT CHANGE"),
shall be made in accordance with the Change Control procedure set out in Section
2.5 below. For the avoidance of doubt the Change Control Procedure, set out at
Section 2.5 below, shall not apply to modifications that do not effect the legal
or regulatory obligations of GSK in the Territory, or the Product's quality,
efficacy or safety.
2.5 Change Control Procedure.
(a) GSK shall provide ALLERGAN with written notice of any Product
Changes directed or recommended by the Regulatory Authority in the Territory as
soon as reasonably practicable and ALLERGAN shall promptly determine how best to
implement such Product Changes. If ALLERGAN determines that the Product Changes
directed or recommended by the Regulatory Authority in the Territory will
involve implementation costs of greater than ***, the parties will conduct good
faith negotiations to determine how best to implement the Product Changes.
(b) ALLERGAN shall provide GSK with written notice of any proposed
Product Changes instigated by ALLERGAN at its discretion or by GSK in accordance
with Section 2.5(a) as soon as reasonably practicable.
(c) GSK shall promptly review the proposal for Product Change and
respond in writing on whether the proposed Product Change requires any
notification to, or request for pre-approval from, the Regulatory Authority in
the Territory.
(d) Where GSK determines that the proposed Product Change requires
notification or pre-approval from the Regulatory Authority in the Territory,
ALLERGAN will provide appropriate information to support GSK's submission to the
Regulatory Authority and shall maintain sufficient supplies of approved Product
to supply GSK its requirements for the Territory until approvals from a
Regulatory Authority of amendments to the Marketing Authorization in the
Territory is obtained for any Product Changes.
(e) Any disagreement between the parties regarding Product Changes or
that arises during this Change Control procedure shall be discussed by the
party's relevant technical or operational representatives in good faith and in a
consultative manner and escalate the matter
*** 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 Exchange Act
of 1934, as amended.
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within their internal lines of reporting as may be necessary. Where the parties
are unable to resolve a disagreement in relation to the legal obligations of
either party it will be resolved in accordance with the dispute resolution
procedures set out in Section 10.9 of this Supply Agreement.
2.6 Lead Contacts. Each party shall appoint a lead contact (who for
ALLERGAN shall be a senior manufacturing manager of ALLERGAN or Allergan, Inc.
and for GSK shall be a senior manufacturing manager of the Procurement &
Contract Manufacturing department of GSK's Global Manufacturing and Supply
Division) for the activities contemplated by this Supply Agreement. The lead
contact for each party shall be identified to the other party not later than ten
(10) days after the Effective Date. Either party may change its lead contact
upon written notice to the other party. In an endeavor to promote efficient and
effective sales and operations planning, the appropriate personnel from each
party shall meet in person or by telephone at mutually convenient times/places
on a regular basis to discuss, consider and, if seen fit, implement such sales
and operations planning measures as they consider appropriate to promote the
objects of this Supply Agreement. The Lead Contacts will also discuss, on a
regular basis, the strategies that ALLERGAN has in place to manage any risks
relating to interruption to supply.
3. PRICE AND PAYMENT
3.1 Purchase Price.
3.1.1 Supply Price. For each Unit of Product supplied to GSK
hereunder, GSK shall pay ALLERGAN a price per Unit of Product equal to
ALLERGAN's Standard Cost per Unit in the Calendar Year in which the delivery
date specified by GSK occurs, as such Standard Cost is determined in accordance
with this Supply Agreement, plus *** (the "PRICE"). The Standard Cost as of the
Effective Date is *** per Unit, and the Price to be paid by GSK per Unit as of
the Effective Date is therefore ***. ALLERGAN may, though it shall not be
obliged to, use the assistance and expertise of GSK to identify and target
potential areas of reduction to its Standard Cost.
3.1.2 Amendments to Supply Price. ALLERGAN shall recalculate the
Standard Cost once during the fourth quarter of each calendar year (either
upward or downwards as the case may be) (the "RECALCULATED STANDARD COST") to
become effective 1 January of the succeeding year. ALLERGAN shall provide GSK
with written notice detailing each Recalculated Standard Cost promptly after its
determination. Subject to the reconciliation process set out in Section 3.1.4
below, the Price paid by GSK from 1 January in each succeeding year during the
Term shall be the Recalculated Standard Cost for that year plus ***.
3.1.3 Maximum Increase. For the purposes of the reconciliation process
set out in Section 3.1.4 below, (A) the maximum allowable increase to the
Standard Cost for calendar years through the end of *** shall be ***and (B) the
maximum allowable increase to the Standard Cost for calendar years from and
after *** shall be *** (the "ALLOWABLE STANDARD COST"). When calculating the
Allowable Standard Cost for each Calendar Year after the first Calendar Year,
the
*** 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 Exchange Act
of 1934, as amended.
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'Standard Cost' referred to in this Section 3.1.3 shall be the lower of
Recalculated Standard Cost or the Allowable Standard Cost for the immediately
preceding Calendar Year.
3.1.4 Reconciliation Process. In circumstances where the Recalculated
Standard Cost exceeds the Allowable Standard Cost, ALLERGAN will give a credit
to GSK to be used against the royalty payable under the License Agreement in an
amount equal to the difference between (A) the Recalculated Standard Cost plus
*** and (B) the Allowable Standard Costs plus***, multiplied by the number of
Units purchased by GSK during the given year. A working example of this
reconciliation process is set forth in Exhibit G.
3.2 Invoices. ALLERGAN shall invoice GSK or GSK's nominated Affiliate for
all Product purchased by GSK upon shipment in accordance with the delivery terms
and the requirements of Section 4.4 and such invoices shall be paid by GSK
within sixty (60) days of the date of the invoice. All amounts shall be invoiced
and paid in U.S. Dollars. Each invoice issued by ALLERGAN hereunder shall
specify: (a) the price in respect of the Product delivered; (b) the quantity of
the Product delivered; and (c) the amount of tax due in respect of the Product
delivered (if any).
3.3 Taxes. All amounts in this Supply Agreement are stated exclusive of VAT
and Indirect Taxes. GSK is responsible for the payment of all such appropriately
levied taxes to ALLERGAN. ALLERGAN will provide to GSK within thirty (30) days
of the receipt of any consideration, valid VAT invoice if appropriate. Should
such amounts of VAT be refunded subsequently by the fiscal authorities to
ALLERGAN, ALLERGAN will refund these monies to GSK within thirty (30) days of
receipt.
3.4 Wire Transfers. All payments hereunder shall be made to ALLERGAN by
bank wire transfer in immediately available funds to ALLERGAN in accordance with
the wire instructions set forth in Exhibit E, which may be changed only by
written notice to GSK from the Chief Financial Officer of ALLERGAN under Section
10.7 (Notices).
3.5 Late Payments. Subject to the other terms of this Supply Agreement,
payments not made to ALLERGAN within the time period set forth in this Article 3
shall bear interest at an annual rate equal to *** per month. The payment of
such interest shall not limit ALLERGAN from exercising any other rights it may
have under this Supply Agreement as a consequence of the lateness of any
payment.
3.6 Financial Audit Rights. ALLERGAN shall permit its independent
registered public accounting firm, who as of the Effective Date is Ernst & Young
LLP, acting for GSK, to have access, no more than once in each calendar year
during the term of this Supply Agreement, during regular business hours and upon
at least thirty (30) days' written notice, to ALLERGAN's records and books only
to the extent necessary to determine the accuracy of the Standard Cost or
Recalculated Standard Cost (as the case may be). Any report provided by
ALLERGAN's company appointed auditors to GSK shall, unless mutually agreed
between the parties, be limited to:
*** 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 Exchange Act
of 1934, as amended.
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(i) a statement to verify that the Standard Cost is consistent or
equivalent with ALLERGAN's internal standard cost; and
(ii) in circumstances where the Standard Cost or Recalculated Standard
Cost charged by ALLERGAN has been determined by the auditor to
have been higher than ALLERGAN's internal standard cost,
disclosure of the actual standard cost.
If such examination results in a determination that the Standard Cost or
Recalculated Standard Cost has been overstated, amounts overpaid by GSK shall be
refunded by ALLERGAN promptly. The fees and expenses of ALLERGAN's company
appointed auditors for conducting the services set out in this Section 3.6 shall
be paid by GSK unless the examination results in a determination that Standard
Cost or Recalculated Standard Cost have been overstated, or that amounts have
been overpaid by GSK, by more than *** for the period examined, in which case
ALLERGAN shall pay all reasonable costs and expenses of such auditor.
4. FORECASTS, ORDERS AND SHIPMENT
4.1 Rolling Forecasts. Prior to the beginning of each calendar quarter
during the Term, GSK shall provide ALLERGAN with a written forecast of GSK's
expected requirements for Product during the following eighteen (18) months
broken down by months (M1 through M18), and which shall include projected order
dates, quantities and shipping dates ("ROLLING FORECASTS"). The initial Rolling
Forecast shall be delivered to ALLERGAN by GSK within two (2) weeks after the
Effective Date. As pertains for each Rolling Forecast, the Units of Product set
forth in the first three (3) months designated M1-M3 shall be firm orders
binding on GSK, and the forecast for the second three (3) months designated
M4-M6 may only be increased or decreased by up to *** in the aggregate from the
original forecast for such months as the forecast is rolled forward at the
beginning of the next quarter (but in no event shall any order be for less than
*** Units), unless otherwise agreed to by ALLERGAN. Except as set forth in this
Section 4.1, the Rolling Forecasts shall be non-binding.
4.2 Purchase Orders. Products shall be ordered by GSK by written or
electronic purchase order (or by any other means agreed to by the parties), the
initial form of which is attached as Exhibit B ("PURCHASE ORDER"). The initial
Purchase Order of Product by GSK to cover the balance of the calendar quarter in
which the Effective Date falls, which may account for a reasonable build of
stock for inventory purposes, shall be provided before or with the initial
Rolling Forecast. Prior to the beginning of each calendar quarter, but at least
thirty (30) days prior to the earliest desired date of delivery, GSK shall place
binding Purchase Orders for Product for M1-M3 as specified in the Rolling
Forecast to begin delivery in M1 of that calendar quarter, and shall be
consistent with the forecast provided for such calendar quarter in that Rolling
Forecast. Each Purchase Order must be for a minimum order of *** Units. Purchase
Orders placed by GSK may not be changed without ALLERGAN's prior written
consent. For the avoidance of doubt, the minimum order quantity for each
Purchase Order set out in this Section 4.2 does not represent a minimum annual
volume commitment by GSK. To the extent of any conflict or inconsistency between
this Supply Agreement and any Purchase Order, purchase order release,
confirmation,
*** 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 Exchange Act
of 1934, as amended.
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acceptance or any similar document pertaining to the supply of Product for sale
in the Territory, the terms of this Supply Agreement shall govern.
4.3 Manufacture and Shipment. ALLERGAN shall deliver to GSK the number of
Units of Product specified in each Purchase Order no later than the dates
specified therein. ALLERGAN shall exercise the same diligence in meeting GSK's
requirements of Product as it exercises with respect to its own requirements.
4.4 Delivery Terms. Shipments of Product to GSK shall be made FCA
Manufacturing Facility, Westport, Ireland, INCOTERMS 2000 (as defined by the
International Chamber of Commerce (ICC)). Delivery will not be complete unless
each shipment is accompanied by a valid Certificate of Analysis and Compliance
and any required export documentation.
4.5 Manufacturing Capacity. ALLERGAN undertakes to ensure that it has at
all times sufficient Manufacturing capacity at the Manufacturing Facilities to
satisfy GSK's Product requirements set out in the Rolling Forecasts.
(a) ALLERGAN shall routinely monitor the Manufacturing capacity
available to GSK at the Manufacturing Facilities, such that ALLERGAN shall make
appropriate changes to its utilization of such capacity to satisfy GSK's
requirements of Product in accordance with this Supply Agreement.
(b) GSK and ALLERGAN shall review and discuss the Manufacturing
capacity available at the Manufacturing Facilities in relation to the Rolling
Forecast as part of the regular review meetings pursuant to Section 2.6.
(c) In the event of a break or fault in production that can reasonably
be foreseen to affect supply of Product to GSK, ALLERGAN shall notify GSK
promptly if such fault cannot be remedied within five (5) business days and,
following such notification, will keep GSK apprised of the status of the
remedial action to be taken by ALLERGAN. ALLERGAN shall in any event use its
best endeavors to ensure a return to production as soon as possible.
4.6 Minimum Inventory. During the Term, ALLERGAN shall maintain not less
than *** rolling stock of inventory of Product for the Territory (work in
process inventory shall be included in this calculation) and approximately ***
supply of Materials throughout the supply chain ("RESERVE SUPPLY"), excepting
where such Reserve Supply is used to fulfill Purchase Orders, in which case it
shall be replaced within ***. For the avoidance of doubt, the Reserve Supply
shall be Product dedicated to GSK (but not necessarily labelled for GSK) and not
used for any other customers of ALLERGAN or ALLERGAN itself. Within thirty (30)
days after the Effective Date and thereafter during the Term, GSK shall maintain
*** of inventory of Product in the Territory. The amounts of inventory specified
in this Section shall be based on the Rolling Forecast.
4.7 Incomplete Delivery. GSK shall notify ALLERGAN as soon as reasonably
practicable, and in no event later than three (3) business days after receipt of
the delivery at GSK'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 Exchange Act
of 1934, as amended.
10
site in Japan, if there is an incomplete delivery in accordance with the terms
of this Supply Agreement. If ALLERGAN is notified of the incomplete delivery by
telephone or in person, then such notification shall be confirmed by GSK in
writing. ALLERGAN shall rectify the incomplete delivery, making it up from the
Reserve Supply if necessary, within fourteen (14) business days after the first
date of notification.
4.8 Failure to Meet Requirements. If ALLERGAN is unable, or anticipates
that it will be unable, to supply at least *** of the Product ordered on any
Purchase Order placed in accordance with Section 4 from its current production
or normal stocks, ALLERGAN shall, promptly after it becomes aware of such fact,
and in any event not less than fourteen (14) days before the due delivery date,
give written notice to GSK of the reasons for the shortfall. ALLERGAN will make
up the shortfall in the next delivery of Product ordered by GSK. GSK's remedies
in the event of any failure of ALLERGAN to supply GSK's requirements under this
Supply Agreement are set forth in the License Agreement. GSK's SOLE AND
EXCLUSIVE REMEDIES FOR FAILURE OF SUPPLY SHALL BE LIMITED TO THE REMEDIES
PROVIDED IN THE LICENSE AGREEMENT.
5. QUALITY AND SAFETY
5.1 Compliance. ALLERGAN shall Manufacture and supply Product, and maintain
and operate the Manufacturing Facilities, in accordance with this Supply
Agreement, the Specifications, all applicable laws and regulations and the
applicable Marketing Authorizations, including any applicable cGMPs, Good
Quality Practices ("GQPS"), Good Vigilance Practices ("GVPS") provisions
promulgated by the Regulatory Authority in the Territory or the country of
Manufacture.
5.2 Inspection by Regulatory Authorities. ALLERGAN shall permit
representatives of appropriate Regulatory Authorities from the Territory or
country of Manufacture to inspect the Manufacturing Facilities to verify the
Product and API is being manufactured and supplied in accordance with cGMPs,
GQPs, GVPs and Product Specifications, API specifications and in accordance with
the Manufacturing Authorizations and Marketing Authorizations. ALLERGAN shall
provide GSK with a copy of any report or deficiency notice arising from such
inspections conducted by Regulatory Authorities from the Territory or country of
Manufacture, appropriately redacted to maintain confidentiality of ALLERGAN's
proprietary trade secrets, however, for the avoidance of doubt, any major or
critical observations of the Regulatory Authority will be disclosed in
un-redacted form. GSK shall have the right to make recommendations to ALLERGAN
regarding corrective action provided that ALLERGAN shall make the final
determination with respect to the corrective action taken. ALLERGAN shall
promptly remedy or cause the remedy of any deficiencies which may be noted in
any such inspection by the Regulatory Authority.
5.3 ***
5.4 Inspections by GSK of the Secondary Manufacturing Facility. GSK may,
subject to Section 9 relating to Confidentiality, conduct routine inspections of
the Secondary Manufacturing
*** 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 Exchange Act
of 1934, as amended.
11
Facility to verify the Product is being Manufactured and supplied in accordance
with cGMPs, GQPs, GVPs and Product Specifications and in accordance with the
Manufacturing Authorizations and Marketing Authorizations. *** Plant inspections
by GSK shall be conducted during normal business hours on not less than thirty
(30) days advance written notice, and shall occur no more frequently than once
in any twelve (12) consecutive month period, provided that GSK shall have the
right to carry out follow up inspections where it is legally obliged to do so.
GSK shall have the right to carry out inspections For Cause at any time. Any For
Cause inspection will be limited to an investigation of the For Cause issue to
discover the root cause. ALLERGAN and GSK shall meet after each inspection to
discuss the results of the inspection. ALLERGAN shall give due consideration to
observations and recommendations made by GSK at such meetings. Any Product
Changes as a result of the inspection shall be made in accordance with the
Change Control procedure set out in Section 2.5. Any disagreements between the
parties regarding the results of the inspection shall be discussed by the
party's relevant technical or operational representatives in good faith and in a
consultative manner and escalate the matter within their internal lines of
reporting as may be necessary. Where the parties are unable to resolve a
disagreement in relation to the legal obligations of either party it will be
resolved in accordance with the dispute resolution procedures set out in Section
10.9 of this Supply Agreement.
5.5 Shelf Life. The shelf life of the Product is two (2) years. Product
shall have a minimum of *** of shelf life remaining at time of delivery to GSK.
5.6 Specification Testing. ALLERGAN shall test or cause to be tested, in
accordance with the test methods and procedures set forth in Exhibit C, each Lot
sold to GSK before delivery to GSK. ALLERGAN shall provide GSK with a
Certificate of Analysis and Compliance, which shall accompany each Lot delivered
to GSK. In addition, GSK may test or cause to be tested each shipment of Product
received by GSK for the Territory. FOR THE AVOIDANCE OF DOUBT, EXCEPT AS SET OUT
IN SECTION 5.10, ANY TESTING BY GSK SHALL NOT SERVE TO LIMIT OR EXCLUDE
ALLERGAN'S LIABILITY OR RELIEVE ALLERGAN FROM ITS OBLIGATIONS SET OUT IN THIS
SUPPLY AGREEMENT.
5.7 Replacement or Credit for Refund. If GSK rejects any Lot of Product,
GSK shall promptly notify ALLERGAN in writing of the reason(s) for rejection.
Following discussion with GSK and by mutual agreement ALLERGAN shall, either
promptly replace the entire Lot in which the defective Product was found and
deliver it to GSK at ALLERGAN's sole cost and expense or credit to GSK the
invoiced amount of the entire Lot in which the defective Product was found and
credit to GSK the actual cost of transportation and storage of the defective
Product incurred by GSK. After consultation with ALLERGAN, GSK may dispose of
any defective Lot in such reasonable manner as GSK determines in its sole
discretion at ALLERGAN's cost and expense. OTHER THAN THE REMEDIES FOR FAILURE
TO SUPPLY SET OUT IN THE LICENSE AGREEMENT, GSK's SOLE AND EXCLUSIVE REMEDY FOR
REJECTION OF ANY LOT OR ANY UNITS OF ANY LOT SHALL BE LIMITED TO THE REMEDY
PROVIDED IN THIS SECTION.
5.8 Disputes Regarding Defect Claims. In the event of a dispute between the
parties over the validity of a rejection of a Lot of Product, GSK and ALLERGAN
agree to submit samples
*** 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 Exchange Act
of 1934, as amended.
12
of the rejected Product to an independent test facility to be agreed upon by
both parties, and to accept the results of the testing performed by that
facility as binding with regard to that Lot. The expense of such testing shall
be borne by the losing party. The parties acknowledge that the time period for
accurate testing for the Product could impact the flow of Product to market and
that it may be necessary to send a replacement Lot of Product (which ALLERGAN
shall invoice GSK for in the normal course of business) pending determination or
resolution of the validity of a rejection.
5.9 Adverse Event (AE) and Serious Adverse Event (SAE) Reporting. GSK and
ALLERGAN shall each comply with their obligations in relation to medical event
reporting requirements as set out in the License Agreement.
5.10 Product Recall. If any Regulatory Authority in the Territory orders or
requires the recall of any Product in the Territory, or if in GSK's opinion a
recall is necessary in the Territory, GSK will promptly notify ALLERGAN and
provide such information regarding such recall order or other information as may
be reasonably requested by ALLERGAN. GSK shall, unless prohibited by applicable
law, consult with ALLERGAN on the need for a recall and take all ALLERGAN
submissions into account when making a decision whether to instigate a recall
(such decision not to be unreasonably made). GSK shall be responsible for
conducting any recall of Product in the Territory and ALLERGAN shall co-operate
with GSK by providing all such information and assistance as may be reasonably
required to implement such recall. To the extent that any recall of the Product
is implemented as a result of ALLERGAN's failure to Manufacture Product in
accordance with the terms and conditions of this Supply Agreement, ALLERGAN
shall (i) bear all direct expenses incurred by GSK in connection with such
recall, (ii) shall indemnify the GSK Indemnitees (as defined in Section 7.1)
from any and all Liabilities (as defined in Section 7.1) incurred by any GSK
Indemnitee, to the extent that these are proven to be attributable to ALLERGAN's
failure to Manufacture Product in accordance with the terms and conditions of
this Supply Agreement and (iii) shall either, at GSK's sole option, replace or
credit GSK for the cost of the relevant Lots of the Product subject to the
recall. If a recall of Product is required due to any negligence or willful
misconduct of a GSK Indemnitee, including without limitation any recall that
could have been avoided but was not avoided due to a failure of GSK to perform
the testing allowed by Section 5.6, GSK shall bear all such costs and expenses
incurred in connection with such recall and shall indemnify the ALLERGAN
Indemnitees from and against any and all Liabilities incurred by an ALLERGAN
Indemnitee that are proven to be attributable solely to the negligence or
willful misconduct of GSK. If any Regulatory Authority outside the Territory
orders or requires the recall of any of the Products outside the Territory then
ALLERGAN will promptly notify GSK and provide such information regarding such
recall order or other information as may be reasonably requested by GSK. EXCEPT
AS SET FORTH IN ARTICLE 7 (INDEMNIFICATION), EACH PARTY'S SOLE AND EXCLUSIVE
REMEDIES FOR RECALLED PRODUCT SHALL BE LIMITED TO THE REMEDIES PROVIDED IN THIS
SECTION AND, IF RELEVANT, THE REMEDIES FOR FAILURE TO SUPPLY SET OUT IN THE
LICENSE AGREEMENT.
5.11 Quality Obligations. Exhibit F sets forth additional provisions
governing the Manufacture by ALLERGAN of Product supplied to GSK. In the event
of any inconsistencies
*** 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 Exchange Act
of 1934, as amended.
13
between the terms of the body of this Supply Agreement and the Quality
Obligations, the terms of the Supply Agreement shall govern.
5.12 Reference Standard Product. Upon written request from GSK, ALLERGAN
shall supply a reasonable quantity of reference standard Product as needed by
GSK to complete government required testing.
6. REPRESENTATIONS AND WARRANTIES; ADDITIONAL COVENANTS OF GSK
6.1 By ALLERGAN. ALLERGAN represents and warrants that:
6.1.1 it is a corporation duly organized, validly existing and in good
standing under the laws of the Cayman Islands and has taken all necessary
action, including, without limitation, obtaining any necessary approval of its
board of directors, to execute and deliver this Supply Agreement;
6.1.2 it has the corporate power and authority and the legal right to
own and operate its property and assets, to lease the property and assets it
operates under lease, and to carry on its business as it is now being conducted;
6.1.3 it has full power and authority to enter into and perform this
Supply Agreement and does not require any shareholder action or approval, and
that this Supply Agreement constitutes and when executed will constitute, its
legal, valid and binding obligation, enforceable in accordance with its terms,
except as may be limited by bankruptcy and equitable principles limiting
specific performance;
6.1.4 the execution, delivery and performance of this Supply Agreement
by ALLERGAN shall not constitute a breach or default, or an event which with the
giving of notice or passage of time or both would constitute a breach or
default, under any contract, instrument, law or other obligation to which it is
a party or by which it or any of its assets may be bound;
6.1.5 it shall Manufacture and supply the Products in accordance with
the terms of this Supply Agreement including but not limited to the Quality
Obligations and shall comply with all Marketing Authorizations, Manufacturing
Authorizations, cGMPs and laws and regulations relevant to their Manufacture and
sale;
6.1.6 all Products Manufactured, sold and shipped pursuant to this
Supply Agreement shall be Manufactured in accordance with all applicable
national and local environmental, health and safety laws and regulations in
effect at the time and place of Manufacture of the Products;
*** 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 Exchange Act
of 1934, as amended.
14
6.1.7 all waste, including but not limited to all hazardous waste,
generated at the time of Manufacture of the Products shall be disposed of in
accordance with all applicable laws and regulations governing such matters in
the country of the Manufacturing Facilities; and
6.1.8 unless otherwise required or prohibited by law, to the best of
its knowledge and in relation to the supply of Product under the terms of this
Supply Agreement, it complies with the requirements set out in Exhibit H,
Ethical Standards and Human Rights
6.2 By GSK. GSK represents and warrants that:
6.2.1 it is a public limited company duly organized, validly existing
and in good standing under the laws of England has taken all necessary action,
including, without limitation, obtaining any necessary approval of its board of
directors, to execute and deliver this Supply Agreement,
6.2.2 it has the corporate power and authority and the legal right to
own and operate its property and assets, to lease the property and assets it
operates under lease, and to carry on its business as it is now being conducted,
6.2.3 it has full power and authority to enter into and perform this
Supply Agreement and does not require any shareholder action or approval, and
that this Supply Agreement constitutes and when executed will constitute, its
legal, valid and binding obligation, enforceable in accordance with its terms,
except as may be limited by bankruptcy and equitable principles limiting
specific performance, and
6.2.4 the execution, delivery and performance of this Supply Agreement
by GSK shall not constitute a breach or default, or an event which with the
giving of notice or passage of time or both would constitute a breach or
default, under any contract, instrument, law or other obligation to which it is
a party or by which it or any of its assets may be bound.
6.3 Disclaimer. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN SECTION 6.1
AND IN THE LICENSE AGREEMENT, ALLERGAN MAKES NO, AND HEREBY DISCLAIMS ANY AND
ALL, REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE
PRODUCTS, INCLUDING WITHOUT LIMITATION, THE WARRANTIES OF MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE, AND NONINFRINGEMENT OF ANY THIRD PARTY'S
PROPRIETARY RIGHTS.
*** 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 Exchange Act
of 1934, as amended.
15
6.4. Restrictive Covenant of GSK.
6.4.1 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 6.4.2) 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 Product, which is valuable and highly confidential to ALLERGAN
and critical to the competitive success of ALLERGAN's business worldwide;
6.4.2 To the extent permitted under applicable law, during the Term
and for a period of *** after the expiration date of this Supply Agreement or
the effective date of the termination of this Supply Agreement for any reason
other than by GSK pursuant to Sections 8.2 or 8.3 (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 Product (a "COMPETING PRODUCT") in the Field of Use; provided, however
that:
6.4.3 If GSK or any of its Affiliates manufactures, initiates clinical
studies, markets, distributes, sells, promotes or details (collectively,
"COMMERCIALIZATION") a Competing Product *** 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 Supply
Agreement and any other agreement between the Parties relating to Product in the
Other Territories, which termination by ALLERGAN of this Supply Agreement will
be deemed a termination of this Supply Agreement by ALLERGAN pursuant to Section
8.2. During the period between the date that GSK becomes aware of
commercialization of a Competing Product as provided in this Section 6.4.3 and
the earlier of the date on which GSK ceases such commercialization and
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 are calculated in the
License Agreement). Notwithstanding the foregoing, if GSK or any of its
Affiliates has used ALLERGAN's Know-How or Confidential Information in
connection with the commercialization of a Competing Product as provided in this
Section 6.4.3, ALLERGAN will have the right to immediately terminate this Supply
Agreement and any other agreement between the Parties relating to Product in
other territories upon thirty (30) calendar days' prior written notice to GSK,
which termination by ALLERGAN will be deemed a termination of this Supply
Agreement by ALLERGAN pursuant to Section 8.2; and
6.4.4 Notwithstanding anything contained in this Section 6.4, 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 in
6.4.4(a)) (ii) being acquired by a Business Entity; or (iii) merging,
amalgamating,
*** 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 Exchange Act
of 1934, as amended.
16
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 6.4.4 are collectively referred to as "Merger" or "MERGING").
(a) The term "BUSINESS ENTITY" as used in this Section 6.4.4
means any Person which, at the time of such Merger, is commercializing (as such
term is defined in Section 6.4.1) a Competing Product ***, including, for
example, the Persons listed in Exhibit D.
(b) 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
Know-How or Confidential Information in connection with the commercialization of
such Competing Product; and (B) GSK will continue to comply with the terms of
this Supply Agreement in all respects. If GSK does not divest or cause the
divesture of such Competing Product within *** after the Merger Date, ALLERGAN
may, at any time thereafter, shall have the right to terminate this Supply
Agreement and any other agreement between the parties relating to the Product in
other territories, which termination by ALLERGAN will be deemed a termination by
ALLERGAN pursuant to Section 8.2. In the event that GSK does not divest or cause
the divesture of such Competing Product within the *** period as provided in
this Section 6.4.4(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.
6.5. Japan Matters. During the Term, GSK shall promptly (i) provide
ALLERGAN with copies of all correspondence and notices from the Regulatory
Authority in the Territory and (ii) inform ALLERGAN regarding any changes in all
applicable laws and regulations in the Territory, including without limitation
any applicable cGMPs, GQPs and GVPs provisions promulgated by the Regulatory
Authority in the Territory.
7. INDEMNIFICATION AND INSURANCE
7.1 Indemnification by ALLERGAN. Except in any case to the extent such
Liabilities (as defined below) are the responsibility of GSK under Section 7.2
(Indemnification by GSK), ALLERGAN shall indemnify, defend and hold GSK and its
Affiliates and their officers, directors, agents and employees (each and
collectively a "GSK INDEMNITEE") harmless from and against any claims, any and
all liabilities, damages, losses, costs and expenses, investigations, and
reasonable attorneys' fees incurred hereunder (each and collectively a
"LIABILITY") resulting from or arising out of a claim, suit, or proceeding
brought by a Third Party against a GSK Indemnitee arising out of or in
connection with
7.1.1 the Manufacture of the Product in accordance with this Supply
Agreement,
*** 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 Exchange Act
of 1934, as amended.
17
7.1.2 material breach by any ALLERGAN Indemnitee of any of ALLERGAN's
representations, warranties or obligations under this Supply Agreement,
7.1.3 any willful misconduct or negligent act or omission of any ALLERGAN
in performing ALLERGAN's obligations under this Supply Agreement, and/or
7.1.4 a recall of the Product attributable to the Manufacture of the
Product by ALLERGAN.
7.2 Indemnification by GSK. GSK shall indemnify, defend and hold harmless
ALLERGAN and its Affiliates and their officers, directors, agents and employees
(each and collectively an "ALLERGAN INDEMNITEE") from any Liabilities resulting
from a claim, suit or proceeding brought by a Third Party against an ALLERGAN
Indemnitee arising out of or in connection with (i) the material breach by any
GSK Indemnitee of any of its representations, warranties or obligations under
this Supply Agreement, (ii) any willful misconduct or negligent act or omission
of GSK in performing GSK's obligations under this Supply Agreement, or (iii) a
recall of the Product attributable solely to the negligence of GSK; except in
any case to the extent such Liabilities are the responsibility of ALLERGAN under
Section 7.1 (Indemnification by ALLERGAN) of this Supply Agreement.
7.3 Procedure. A party asserting a claim for indemnification under Section
5.9 or this Article 7 shall notify the indemnifying party in writing of any such
claims as follows: (a) within fifteen (15) days of receipt of service of process
of the commencement of suit, or (b) for non-litigated matters, within thirty
(30) days of receipt of notice thereof; provided, however, that failure to give
such notice shall not relieve the indemnifying party of its obligation to
provide indemnification hereunder except, if and to the extent that such failure
materially and adversely affects the ability of the indemnifying party to defend
the applicable claim, suit or proceeding. The indemnifying party shall be
entitled to assume sole control over the defense of any such claim at its own
cost and expense; provided, however, that the indemnitee shall have the right to
be represented by its own counsel at its own cost in such matters. Neither the
indemnifying party nor the indemnified party shall settle or dispose of any such
matter in any manner which would adversely affect the rights or interests of the
other party, require the other to be subject to an injunction, or require the
other to make any monetary payment, without the prior written consent of the
other party, which shall not be unreasonably withheld or delayed. Each party
shall reasonably cooperate with the other party and its counsel in the course of
the defense of any such suit, claim, or demand, such cooperation to include
without limitation using reasonable efforts to provide or make available
documents, information and witnesses.
7.4 Insurance. Each party, at its own expense, shall maintain commercial
general/product liability insurance including coverage for clinical trials with
a minimum limit of liability per occurrence of *** and *** in the annual
aggregate, or self insure for any such amounts, and, upon request, shall provide
the other party with a certificate of such insurance. Each party shall provide
at least thirty (30) days' notice to the other party prior to cancellation or
material change in the relevant party's insurance policy.
*** 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 Exchange Act
of 1934, as amended.
18
7.5 Limitation of Liability. With respect to any claim by one party against
the other arising out of the performance or failure of performance of the other
party under this Supply Agreement, the parties expressly agree that the
liability of such party to the other party for such breach shall be limited
under this Supply Agreement or otherwise at law or equity to direct damages
only. IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR ANY
INDIRECT, SPECIAL, PUNITIVE, EXEMPLARY, INCIDENTAL OR CONSEQUENTIAL DAMAGES,
INCLUDING WITHOUT LIMITATION, LOSS OF PROFIT, LOSS OF BUSINESS, LOSS OF SAVING
OR OTHER CONSEQUENTIAL LOSS. The limitations set forth in this Section 7.5 shall
not apply with respect to the obligations of ALLERGAN to indemnify GSK under
Section 7.1 or GSK to indemnify ALLERGAN under Section 7.2 in connection with a
Claim of a Third Party.
8. TERM AND TERMINATION
8.1 Term. The term of this Supply Agreement shall commence upon the
Effective Date and shall continue until the expiration or termination of the
License Agreement, unless extended by the mutual agreement of the parties or
terminated sooner pursuant to Sections 8.2, 8.3 or 8.4 (the "TERM").
8.2 Termination Due to Breach. In the event of a material breach or default
of this Supply Agreement by a party hereto that is not cured within *** after
receipt of notice thereof from the other party, the party not in material breach
or default shall be entitled to terminate this Supply Agreement by giving
written notice to the other party, such termination to take effect immediately.
The right to terminate this Supply Agreement shall not be affected in any way by
a waiver of, or failure to take action with respect to, any previous default.
8.3 Termination for Bankruptcy. Either party shall have the right to
terminate this Supply Agreement effective upon written notice to the other party
in the event the other party becomes insolvent or makes an assignment for the
benefit of creditors, or in the event bankruptcy or insolvency proceedings are
instituted against the other party or on the other party's behalf.
8.4 Termination for Safety or Quality Reasons; Material Regulatory
Interruption. GSK will have the right to immediately terminate this Supply
Agreement upon providing thirty (30) calendar days' written notice to ALLERGAN,
if (a) there is a Material Regulatory Interruption (as defined in the License
Agreement) which has lasted for at least *** during the Term; or (b) GSK
reasonably determines, after consultation with ALLERGAN, that there are
significant safety or quality concerns relating to Product that GSK considers
(in accordance with its corporate policies and procedures) justifying that
Product not be sold in the Territory.
8.5 Effect of Termination. Upon termination or expiration of this Supply
Agreement, each party shall promptly return to the other all Confidential
Information of the other party received solely under this Supply Agreement then
in its possession or in the possession of its Affiliates. Any Purchase Orders
received by ALLERGAN prior to the date of termination or expiration for delivery
within thirty (30) days of termination or expiration will be filled by ALLERGAN
and all other Purchase Orders shall be deemed cancelled; provided, however, that
if
*** 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 Exchange Act
of 1934, as amended.
19
this Supply Agreement is terminated due to a breach by GSK. GSK shall have one
hundred and eighty (180) days after expiration or termination (other than for
breach by GSK) of this Supply Agreement to sell off any Product remaining in its
inventory or the inventory of its Affiliates or sublicensees on the date of
expiration or termination. After the expiration of such 180-day period, or in
the event of a termination of this Supply Agreement due to a breach by GSK,
ALLERGAN shall, at its sole option, (A) repurchase any or all of the Products
still in the inventory of GSK, its Affiliates and sublicensees at the Purchase
Price paid by GSK for such Products, in which case GSK shall deliver such
Product to an address notified to it by ALLERGAN, with shipping paid by GSK, or
(B) require GSK to destroy all such inventory at GSK's cost and certify such
destruction in writing no later than thirty (30) days after ALLERGAN's written
instruction to destroy such inventory.
8.6 Survival. The provisions of Articles 6, 7, 9 and 10 and Sections 5.5,
5.6, 5.7, 5.8, 5.9, 8.5, 8.6 and 8.7 shall survive termination or expiration of
this Supply Agreement.
8.7 No Waiver of Remedies. Termination of this Supply Agreement shall not
preclude either party from (a) claiming any other damages, compensation or
relief that it may be entitled to upon such termination, (b) any right to
receive any amounts accrued under this Supply Agreement prior to the termination
date but which are unpaid or become payable thereafter and (c) any right to
obtain performance of any obligation provided for in this Supply Agreement which
shall survive termination.
9. CONFIDENTIALITY
9.1 Confidential Information. "CONFIDENTIAL INFORMATION" means, except as
provided below in this Section 9.1, the terms and conditions of this Supply
Agreement as well as confidential and proprietary information of a party,
whether in written, printed, verbal or electronic form, and whether disclosed
before or after the Effective Date, including research and development
activities, Product design details and specifications, technology and know-how,
sales and marketing plans, finances and business forecasts, procurement
requirements and vendor information, customer lists, personnel information and
strategic plans. Confidential Information will not include information that:
9.1.1 is now, or hereafter becomes generally known or available to the
public through no act or failure to act on the part of the receiving party;
9.1.2 was acquired by the receiving party before receiving such
information from the disclosing party through no breach of any duty of
confidentiality owed to the disclosing party and without restriction as to use
or disclosure;
9.1.3 is hereafter rightfully furnished to the receiving party by a
Third Party without any breach of any duty of confidentiality owed to the
disclosing party and without restriction as to use or disclosure; 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 Exchange Act
of 1934, as amended.
20
9.1.4 is information that the receiving party can document was
independently developed by the receiving party without any use of the disclosing
party's Confidential Information.
9.2 Non-Disclosure of Confidential Information. Each party, when it is the
receiving party agrees: (i) to hold the disclosing party's Confidential
Information in strict confidence and not to disclose such Confidential
Information to any other Third Party without the prior written consent of the
disclosing party; and (ii) not to use, at any time following the Effective Date,
any Confidential Information of the disclosing party for its own benefit or for
the benefit of any Third Party for any purpose other than for the express
purposes permitted under this Supply Agreement or any other agreement between
the parties and/or their respective Affiliates relating to the Product; and
(iii) to limit the disclosure of Confidential Information to Permitted Persons.
For purposes hereof, the term "PERMITTED PERSON" shall mean the receiving
officers and employees of the receiving party or an Affiliate of the receiving
party who have a need to know in order to carry out the obligations under this
Supply Agreement; provided each has agreed in writing to maintain the
confidentiality of the Confidential Information in a manner no less protective
than that set forth herein. The receiving party shall use Confidential
Information of a disclosing party solely to exercise its rights and perform its
obligations under this Supply Agreement (including without limitation the right
to use such Confidential Information in connection with obtaining Marketing
Authorizations in the Territory and to disclose such Confidential Information to
a Regulatory Authority in the Territory), unless otherwise mutually agreed in
writing. The receiving party shall take the same degree of care with
Confidential Information of a disclosing party that it uses to protect its own
confidential and proprietary information of a similar nature and importance (but
in any event no less than reasonable care).
9.3 Disclosure Required by Law. In the event a receiving party is required
to disclose Confidential Information of the disclosing party by any applicable
law, regulation, legal process, judicial order or by any applicable order or
requirement of any governmental or regulatory authority, it may do so only to
the extent required thereby; provided, however, that the receiving party will
(i) use reasonable efforts under the circumstances to provide advance notice to
the disclosing party of the required disclosure to allow the disclosing party an
opportunity to take steps to object to, prevent or limit its disclosure or
obtain a protective or other similar order with respect to the required
disclosure and (ii) restrict disclosure to only that portion of the Confidential
Information that is required to be disclosed.
9.4 Remedies. The receiving party agrees that its obligations hereunder are
necessary and reasonable to protect the disclosing party's business interests
and that the unauthorized disclosure or use of the disclosing party's
Confidential Information would cause irreparable harm and significant injury,
the degree of which may be difficult to ascertain. The receiving party further
acknowledges and agrees that in the event of any actual or threatened breach of
this Supply Agreement, the disclosing party may have no adequate remedy at law
and accordingly, that the disclosing party will have the right to seek an
immediate injunction enjoining any breach or threatened breach of this Supply
Agreement, as well as the right to pursue any and all other rights and remedies
available at law or in equity for such breach or threatened breach.
*** 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 Exchange Act
of 1934, as amended.
21
9.5 Return of Confidential Information. Upon the request of the disclosing
party, the receiving party will promptly return to the disclosing party or, upon
the disclosing party's written approval, destroy all material embodying
Confidential Information of the disclosing party in its possession or under its
control, including all copies thereof; provided that each party may, at such
party's expense, make and retain one (1) copy of the other party's Confidential
Information for legal archival purposes only.
9.6 Disclosure of Agreement, Publicity and Publications. Except as
expressly provided otherwise in Section 9.3 (Disclosure Required by Law),
neither GSK nor ALLERGAN shall release to any Third Party or publish in any way
any non-public information with regard to the terms of this Supply Agreement or
concerning their cooperation without the prior written consent of the other
party, which consent will not be unreasonably withheld or delayed.
Notwithstanding the foregoing, ALLERGAN will issue a press release, public
statement or disclosure regarding this Supply Agreement. Such press release,
public statement or disclosure will be mutually agreed upon by the parties.
Nothing in the foregoing, however, shall prohibit a party from making
disclosures to the extent deemed necessary under applicable federal or state
securities laws or any rule or regulation of any nationally recognized
securities exchange. In such event, however, the disclosing party shall use good
faith efforts to consult with the non-disclosing party prior to such disclosure
and shall request confidential treatment to the extent available. Each party
acknowledges and agrees that the other party shall have the right to submit
manuscripts relating to the Product for scientific publications, A copy of any
scientific abstract or manuscript of results from any clinical trial that is
submitted for publication will be provided by to the other party within thirty
(30) days after such submission. ALLERGAN acknowledges and agrees that GSK may
publish the results of clinical trials conducted by GSK with the Product after
the Effective Date on GSK's Clinical Trial Register and that such publication
will not be a breach of the confidentiality obligations provided in Section 9.2.
ALLERGAN agrees to cooperate with GSK in such effort as further determined in
accordance with the License Agreement, including using commercially reasonable
efforts to provide GSK with the protocols, results, data and other information
relating to all clinical trials conducted by GSK with the Product in ALLERGAN's
possession that GSK reasonably requires to be published on GSK's Clinical Trial
Register.
9.7 Allergan Data Protections. GSK agrees and understands that Confidential
Information of ALLERGAN, including but not limited to data, disclosed to GSK is
very sensitive and ALLERGAN would not enter into this Supply Agreement without
additional assurances from GSK with respect to GSK's use of such Confidential
Information or possible disclosure of such Confidential Information to
ALLERGAN's competitors. Accordingly GSK will not use any such Confidential
Information in connection with any botulinum toxin research and/or development
other than as provided under this Supply Agreement.
9.8 Termination. All obligations of confidentiality and non-use imposed
under this Article 9 will expire *** after the date of expiration or termination
of this Supply Agreement, except that Article 9 obligations of confidentiality
and non-use will continue thereafter with respect to manufacturing and
regulatory information, including without limitation filings with Regulatory
Authorities.
*** 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 Exchange Act
of 1934, as amended.
22
10. GENERAL PROVISIONS
10.1 Integration/Modification. This Supply Agreement, together with the
License Agreement, is both a final expression of the parties' agreement and a
complete and exclusive statement with respect to all of its terms. The Exhibits
referred to in this Supply Agreement are incorporated herein and made a part of
this Supply Agreement by this reference. This Supply Agreement supersedes all
prior and contemporaneous agreements and communications, whether oral, written
or otherwise, concerning any and all matters contained herein; provided,
however, that the confidentiality provisions of Article 9 are in addition to and
do not supersede the terms and conditions of the Confidential Disclosure
Agreement between Allergan Inc, an Affiliate of ALLERGAN, and GlaxoSmithKline
Research & Development Limited, an Affiliate of GSK, dated October 6, 2004, and
any amendments thereto. No rights or licenses are granted or deemed granted
hereunder or in connection herewith other than those rights or licenses
expressly granted in this Supply Agreement or in the License Agreement. No trade
customs, courses of dealing or courses of performance by the parties shall be
relevant to modify, supplement or explain any term(s) used in this Supply
Agreement. This Supply Agreement may not be modified or supplemented by any
purchase order (except as set forth herein), change order, acknowledgment, order
acceptance, standard terms of sale, invoice or the like. This Supply Agreement
may only be modified or supplemented in a writing expressly stated for such
purpose and signed by the parties to this Supply Agreement.
10.2 Relationship Between the Parties. The parties have no ownership
interest in the other and their relationship, as established by this Supply
Agreement, is solely that of independent contractors. This Supply Agreement does
not create any partnership, joint venture or similar business relationship
between the parties. No party is a legal representative of any other party, and
no party can assume or create any obligation, representation, warranty or
guarantee, express or implied, on behalf of any other party for any purpose
whatsoever.
10.3. Non-Waiver. The failure of a party to exercise, enforce or insist
upon strict performance of any provision of this Supply Agreement, or any right
arising out of this Supply Agreement, shall neither impair that provision or
right nor constitute a waiver of that provision or right, in whole or in part,
and will not be construed to be a waiver of such right or provision, or a waiver
by a party to thereafter enforce such right or provision or any other right or
provision hereunder. No waiver shall be effective unless made in writing and
signed by the waiving party.
10.4 Assignment. This Supply Agreement is binding upon and inures to the
benefit of the parties to it, and to their permitted successors and assigns. No
party may assign or delegate any or all of its rights or obligations under this
Supply Agreement without the prior written consent of the other party except to
an Affiliate. Any assignment or delegation, or any other transfer or change of
control by sale, acquisition, merger, or otherwise, or attempt at the same,
other than to an Affiliate, made in the absence of such prior written consent
shall be void and without effect; provided, however, that in the event of the
foregoing, such written consent shall not be unreasonably withheld. If a party
assigns this Supply Agreement to an Affiliate, such party will also promptly
inform the other party and guarantee the performance by its Affiliate of all of
such party's obligations under this Supply Agreement. Either party may, however,
with notice, but
*** 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 Exchange Act
of 1934, as amended.
23
without consent and at its sole discretion, assign all of the rights and
obligations under this Supply Agreement (excluding however, with regard to
ALLERGAN, any of its rights under Section 6.4) to a Third Party in connection
with the transfer or sale of all or substantially all of its business, or in the
event of its merger or consolidation or a change of control or similar
transaction.
10.5 No Third Party Beneficiaries. This Supply Agreement is neither
expressly nor impliedly made for the benefit of any Person other than those
executing it.
10.6 Severability. If, for any reason, any portion of this Supply Agreement
is adjudicated invalid, unenforceable or illegal by a court of competent
jurisdiction, such adjudication shall not affect or impair, in whole or in part,
the validity, enforceability or legality of any remaining portions of this
Supply Agreement. All remaining portions shall remain in full force and effect
as if the original Supply Agreement had been executed without the invalidated,
unenforceable or illegal portion.
10.7 Notices. Any notice to be given under this Supply Agreement must be in
writing and delivered either in person, by any method of mail (postage prepaid)
requiring return receipt, or by overnight courier or facsimile confirmed
thereafter by any of the foregoing, to the party to be notified at its
address(es) given below, or at any address such party has previously designated
by prior written notice to the other. Notice shall be deemed sufficiently given
for all purposes upon the earlier of: (a) the date of actual receipt; (b) if
mailed, three (3) calendar days after the date of postmark; or (c) if delivered
by overnight courier, the next business day the overnight courier regularly
makes deliveries.
If to GSK: Glaxo Group Limited
Glaxo Xxxxxxxx Xxxxx, Xxxxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxx,
XX0 0XX, Xxxxxxx
Attention: Company Secretary
Telephone: (x00) 00 0000 0000
Facsimile: (x00) 00 0000 0000
With a copy to: Legal Operations - GMS
GlaxoSmithKline
000 Xxxxx Xxxx Xxxx
Xxxxxxxxx, Xxxxxxxxx, XX0 0XX, XX
If to ALLERGAN: Allergan Pharmaceuticals Ireland
Xxxxxxxxxx, Xxxxxxxxx Xxxx
Xxxxxxxx Xx.
Xxxx Xxxxxxx
Attention: Colam O'Neil
Telephone No: 000 00 00000
Facsimile No: 353 98 27124
*** 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 Exchange Act
of 1934, as amended.
24
With a copy to: Allergan, Inc.
0000 Xxxxxx Xxxxx
Xxxxxx, Xxxxxxxxxx 00000 X.X.X.
Attention: General Counsel
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
10.8 Force Majeure. Without prejudice to any rights of GSK set out in the
License Agreement in relation to a Material Supply Interruption or Material
Regulatory Interruption, each party shall be excused from liability for the
failure or delay in performance of any obligation under this Supply Agreement by
reason of any event beyond such party's reasonable control which materially
impacts the performance of the relevant party's obligations under this Supply
Agreement including but not limited to acts of God, fire, flood, earthquake, or
other natural forces, war, terrorism, civil unrest, or any other event similar
to those enumerated above (a "FORCE MAJEURE EVENT"). Such excuse from liability
shall be effective only to the extent and duration of the Force Majeure Event
causing the failure or delay in performance and provided that the party has not
caused such Force Majeure Event to occur. Notice of a party's failure or delay
in performance due to Force Majeure Event must be given to the other party
within *** after its occurrence. All delivery dates and performance deadlines
under this Supply Agreement that have been affected by the Force Majeure Event
shall be suspended for the duration of such Force Majeure Event.
10.9 Disputes. If a dispute or controversy regarding any matter under this
Supply Agreement arises between the Parties which they are unable to resolve (a
"DISPUTE"), each of the Parties will (subject to any cure period as set forth in
this Supply Agreement), be entitled to submit to the other party written notice
of such Dispute, with such notice setting forth in reasonable detail the nature
of the Dispute (the "DISPUTE NOTICE"). For a period of thirty (30) calendar days
after the date of the receiving party's receipt of the Dispute Notice, the
Parties will seek to resolve such Dispute by good faith negotiation between the
President of GSK's Global Manufacturing and Supply Division for GSK or his/her
designee and the Senior Vice President, Global Technical Operations for ALLERGAN
or his/her designee. If at the end of such thirty (30) calendar day period the
Dispute remains unresolved, the Parties may seek relief for such Dispute using
any appropriate administrative or judicial mechanism which may be available,
subject to Section 10.11. The provisions of this Section 10.9 will not restrict
in any way the Parties' rights to seek preliminary injunctive or other equitable
relief from any court having jurisdiction.
10.10 Legal Fees. If any party to this Supply Agreement resorts to any
legal action in connection with this Supply Agreement, the prevailing party
shall be entitled to recover reasonable fees of attorneys and other
professionals in addition to all court costs which that party may incur as a
result.
10.11 Governing Law. Notwithstanding its place of execution or performance,
this Supply Agreement, and all claims arising out of or relating to this Supply
Agreement, shall be governed by and construed in accordance with the laws of the
State of New York, irrespective of its laws regarding choice or conflict of
laws. The Parties hereby agree that for the purposes 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 Exchange Act
of 1934, as amended.
25
resolving any Disputes hereunder, in accordance with Section 10.9, that the
Parties hereby submit to the exclusive jurisdiction of the courts of New York.
10.12 Interpretation.
(a) Captions & Headings. The captions and headings of clauses
contained in this Supply Agreement preceding the text of the articles, sections,
subsections and paragraphs hereof are inserted solely for convenience and ease
of reference only and shall not constitute any part of this Supply Agreement, or
have any effect on its interpretation or construction.
(b) Singular & Plural. All references in this Supply Agreement to the
singular shall include the plural where applicable, and all references to gender
shall include both genders and the neuter.
(c) Articles, Sections & Subsections. Unless otherwise specified,
references in this Supply Agreement to any article shall include all sections,
subsections, and paragraphs in such article; references in this Supply Agreement
to any section shall include all subsections and paragraphs in such sections;
and references in this Supply Agreement to any subsection shall include all
paragraphs in such subsection.
(d) Days. All references to days in this Supply Agreement shall mean
calendar days, unless otherwise specified.
(e) Ambiguities. Ambiguities and uncertainties in this Supply
Agreement, if any, shall not be interpreted against either party, irrespective
of which party may be deemed to have caused the ambiguity or uncertainty to
exist.
(f) Including. The word "including" or any variation thereof means
"including without limitation" and the word "including" or any variation thereof
will not be construed to limit any general statement which it follows to the
specific or similar items or matters immediately following it.
10.13 Counterparts. This Supply Agreement may be executed in one or more
counterparts (which may be delivered by facsimile), each of which shall be
deemed an original document, and all of which, together with this writing, shall
be deemed one instrument.
10.14 Further Assurances. Each party to this Supply Agreement shall, at its
own expense, furnish, execute, and deliver all documents and take all actions as
may reasonably be required to effect the terms and purposes of this Supply
Agreement.
10.15 Non-Solicitation. The parties hereto recognize that each party has a
substantial interest in preserving and maintaining confidential its Confidential
Information hereunder. Each party hereto recognizes that certain of the other
party's employees, including those engaged in the activities contemplated by
this Supply Agreement may have access to such Confidential Information of the
other party. The parties hereto therefore agree not to solicit or otherwise
induce
*** 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 Exchange Act
of 1934, as amended.
26
or attempt to induce for purposes of employment, any employees from the other
party involved in the activities contemplated by this Supply Agreement and for a
period of *** thereafter without the prior consent of the other party. For the
avoidance of doubt, the posting of open positions and other such general
recruiting efforts shall not be deemed to constitute direct solicitation.
10.16 Performance by Affiliates. The parties recognize that each party may
perform some or all of its obligations under this Supply Agreement, subject to
the Change Control procedure, through Affiliates, provided, however, that each
party shall remain responsible for the performance by its Affiliates and shall
cause its Affiliates to comply with the provisions of this Supply Agreement in
connection with such performance. Each party hereby expressly waives any
requirement that the other party exhaust any right, power or remedy, or proceed
against an Affiliate, for any obligation or performance hereunder prior to
proceeding directly against such party.
10.17 Compliance with Laws. Each party shall at all times comply with all
applicable laws and regulations in the country of Manufacture and the Territory
relating to its activities under this Supply Agreement.
10.18 No Use of Names. Except as otherwise required under applicable law,
or as otherwise permitted under this Supply Agreement, neither party will use
the name of the other in its advertising, press releases or promotional
materials without the prior written consent of such other party.
IN WITNESS WHEREOF, the parties, intending to be bound hereby, have
executed this Supply Agreement by their duly authorized representatives as of
the date first above written.
ALLERGAN PHARMACEUTICALS GLAXO GROUP LIMITED
IRELAND
By: /s/ COLAM O'NEIL By: /s/ XXXXXXXX DAY
--------------------------------- ------------------------------------
Name: Colam O'Neil Name: Xxxxxxxx Day
------------------------------- ----------------------------------
For and on behalf of
Edinburgh Pharmaceutical Industries
Limited
Title: Director Title: Corporate Director
------------------------------ ---------------------------------
*** 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 Exchange Act
of 1934, as amended.
27
EXHIBIT A
FORM OF CERTIFICATE OF ANALYSIS AND COMPLIANCE
ALLERGAN PHARMACEUTICALS IRELAND
WESTPORT CO. MAYO IRELAND
Telephone No: 000 00 00000
Facsimile No: 353 98 27124
Web Site: xxx.xxxxxxxx.xxx
ALLERGAN BOTOX IRELAND
CERTIFICATE OF ANALYSIS AND COMPLIANCE
(JAPAN)
MATERIAL: BOTOX(R) 100 Units EXPIRY DATE.: _____________
BATCH NO.: _______________________________________ FORMULA NO.: ______________
DATE OF FILL: ____________________________________ MATERIAL NO.: _____________
PRODUCTION LINE: _________________________________
DATE OF LAST VALID POTENCY TEST (MFG DATE): ______
CUSTOMER PRODUCT CODE: ___________________________
MARKETING AUTHORISATION NUMBER: __________________
TEST LIMITS RESULTS
---- ------ -------
*** ***
* Expiry date is calculated from the date of valid potency test plus approved
shelf life.
*** 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 Exchange Act
of 1934, as amended.
BATCH NO.: ___________ DATE OF FILL: _________________
I HEREBY CERTIFY THAT THE BATCH OR BATCHES OF API USED TO MANUFACTURE THIS BATCH
OF DRUG PRODUCT HAS BEEN MANUFACTURED, PACKED AND QUALITY CONTROLLED AT THE
REGISTERED SITES(S) IN FULL COMPLIANCE WITH CGMP REQUIREMENTS INCLUDING THOSE OF
FDA, ICHQ7A AND WITH THE REGISTERED MANUFACTURING PROCESS AND WITH THE
SPECIFICATIONS REGISTERED IN THE MARKETING AUTHORISATION OF THE PRODUCT AND ANY
OTHER APPLICABLE CONDITIONS IN ACCORDANCE WITH THE PHARMACEUTICAL AFFAIRS LAW OF
JAPAN. THE BATCH PROCESSING, PACKAGING AND ANALYSIS RECORDS WERE REVIEWED AND
FOUND TO BE IN COMPLIANCE WITH THE CGMP REQUIREMENTS.
SIGNED: DATE:
----------------------------- ----------------------------------
NAME:
-------------------------------
TITLE:
------------------------------
I HEREBY CERTIFY THAT THE ABOVE INFORMATION IS AUTHENTIC AND ACCURATE. THIS
BATCH OF PRODUCT HAS BEEN MANUFACTURED, PACKED AND QUALITY CONTROLLED AT THE
ABOVE MENTIONED SITES(S) IN FULL COMPLIANCE WITH THE GMP REQUIREMENTS OF THE
EUROPEAN COMMUNITY AND WITH THE SPECIFICATIONS REGISTERED IN THE MARKETING
AUTHORISATION OF THE PRODUCT AND ANY OTHER APPLICABLE CONDITIONS IN ACCORDANCE
WITH THE PHARMACEUTICAL AFFAIRS LAW OF JAPAN. THE BATCH PROCESSING, PACKAGING
AND ANALYSIS RECORDS WERE REVIEWED AND FOUND TO BE IN COMPLIANCE WITH THE GMP
REQUIREMENTS.
EXCEPTIONS (DEVIATIONS) NOTED DURING MANUFACTURING, PACKAGING (IF APPLICABLE)
AND TESTING:
___ NO
___ YES. EXCEPTION REPORT NUMBERS LISTED BELOW AND ATTACH REPORT.
THE ABOVE DRUG PRODUCT HAS BEEN RELEASED FOR SHIPMENT TO GLAXOSMITHKLINE K.K.,
JAPAN.
SIGNED: DATE:
----------------------------- ----------------------------------
NAME:
-------------------------------
TITLE:
------------------------------
(BOTOX(R) LOGO) DIRECTORS. Xxxxx Xxxxxxx; Xxxxxxx X. Xxxxxx (U.S.);
BOTULINUM TOXIN TYPE A Xxx Xxxx Xxx (U.S.); Colem O'Neil;
Purified Neurotoxin Complex Xxxxxxx X'Xxxxxxx.
Registered Dublin No. E 1969.
Registered Xxxxxx Xxxxxxx Xx. XX-000000.
V.A.T. No. IE 9Z68154G
*** 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 Exchange Act
of 1934, as amended.
EXHIBIT B
FORM OF PURCHASE ORDER
(To be supplied within 10 days after Effective Date)
*** 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 Exchange Act
of 1934, as amended.
EXHIBIT C
TESTING METHODS FOR PRODUCT
***
***
TESTING METHODS FOR API
***
*** 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 Exchange Act
of 1934, as amended.
EXHIBIT D
ALLERGAN COMPETITORS
***
*** 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 Exchange Act
of 1934, as amended.
EXHIBIT E
WIRE INSTRUCTIONS
***
*** 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 Exchange Act
of 1934, as amended.
EXHIBIT F
QUALITY OBLIGATIONS
1. OBJECT OF THIS EXHIBIT
This Exhibit defines the quality obligations to be applied by ALLERGAN and
GSK in addition to those defined in the Supply Agreement.
More detailed work processes and definition of responsibilities will be the
subject of a separate operating policy which will be agreed prior to the
transfer of the Regulatory Approval in the Territory to GSK.
2. RESPONSIBLE PERSONS AND CGMP
2.1 GSK and ALLERGAN will each designate senior quality staff to act as
points of contact for the purpose of this Exhibit.
2.2 ALLERGAN will designate an employee who shall have the necessary
experience, qualifications, independence and authority and who will
supervise overall quality assurance of the Manufacture of the Product
(the "Senior Quality Manager"). This includes ensuring that the terms
of this Exhibit and the Supply Agreement are communicated to the
relevant ALLERGAN staff, or staff of ALLERGAN's Authorised
Sub-Contractors (including API manufacturers), and ensuring operations
are performed in strict accordance with cGMP, applicable Regulatory
Approvals and any other applicable law.
2.3 The ALLERGAN Senior Quality Manager will collect and review the data
necessary to make recommendations on the disposition of Materials and
Lots of Product from the Manufacturing Facility. The ALLERGAN Senior
Quality Manager shall establish procedures for providing the
Certificate of Analysis and Compliance and such other information as
is necessary under cGMP, the Regulatory Approvals and applicable law
for GSK to make the final decision on release of Product for sale in
the Territory.
2.4 GSK will designate an employee in the Territory who shall have the
necessary experience, qualifications, independence and authority and
who will supervise acceptance, testing and final release of the
Product for sale in the Territory. This includes ensuring that the
terms of this Exhibit and the Supply Agreement are communicated to the
relevant GSK staff, or staff of GSK's Authorised Sub-Contractors
(including any Third Party that will test the Product in the
Territory), and ensuring such operations are performed in strict
accordance with cGMP, applicable Regulatory Approvals and any other
applicable law.
3. REFERENCE MATERIALS
3.1 Testing will be performed only with reference Materials that are
traceable to pharmacopoeial or other internationally recognised
standards. Use of secondary
*** 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 Exchange Act
of 1934, as amended.
reference Materials must be in accordance with ALLERGAN's validated
process for preparation, storage, maintenance and record keeping for
such secondary reference standards.
3.2 ALLERGAN will supply GSK with the approved and certified reference
Materials which are required by GSK in order to carry out testing of
the Products in the Territory.
4. STORAGE AND SHIPPING
4.1 Up to the delivery of Product to GSK's carrier, ALLERGAN will ensure
Materials and Product are shipped and stored such that the
environmental conditions are maintained, monitored and recorded as
appropriate to meet the conditions specified on the label, cGMP and
any other regulatory requirements.
4.2 From and after the delivery of Product to GSK's carrier, GSK will
ensure Product is shipped and stored such that the environmental
conditions are maintained, monitored and recorded as appropriate to
meet the conditions specified on the label, cGMP and any other
regulatory requirements.
5. NON-CONFORMANCES AND MAJOR PREVENTATIVE ACTIONS
5.1 ***
5.2 ALLERGAN will report to GSK in a timely manner any major improvement
actions that are required to prevent discontinuation of Manufacture,
importation or selling of the Product or that are required to ensure
that recall or disposal of the Product is not required.
5.3 GSK shall promptly report in writing to ALLERGAN regarding any Product
that does not test to Specifications or that is rejected by GSK. GSK
shall also provide a written report, not less often than ***
5.4 If GSK identifies (for example, from customer complaints, or Product
non-conformances) that improvement actions are required to operational
procedures or the Manufacturing Facilities, ALLERGAN must investigate
the matter and correct any issues ALLERGAN identifies as necessary to
meet the requirements of cGMP or address Product non-conformances.
6. ***
7. USE OF THIRD PARTY CONTRACTORS
7.1 For the purposes of this Exhibit F, the term "Authorised
Sub-Contractors" means third party contractors engaged by (i)
ALLERGAN, via validated procedures, to perform any part of ALLERGAN's
cGMP obligations under the License Agreement, Supply Agreement or this
Exhibit (including, but not limited to, laboratory testing services)
or (ii) GSK, via validated procedures, to perform any part of GSK's
testing with respect to the Product in the Territory.
7.2 ALLERGAN and GSK may only use Authorised Sub-contractors. To the
extent required by applicable law, any change to or appointment of a
new Authorised Sub-
*** 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 Exchange Act
of 1934, as amended.
contractors may not occur until GSK has obtained approval from the
Regulatory Authority for a change to the Regulatory Approval in the
Territory.
7.3 Any reference to responsibilities of a Party in this Exhibit is to be
read as applying to any Authorised Sub-contractor for any activities
that they perform on behalf of that Party. Each Party is responsible
for putting in place and enforcing appropriate management systems and
contractual agreements with the Authorised Sub-contractor to ensure
these responsibilities are met.
7.4 The contract with the Authorised Sub-contractor must specifically
include ***
8. RETENTION SAMPLES
ALLERGAN will take and retain representative samples of each Lot of
Materials and Products sufficient to comply with cGMP.
9. COMPLAINT MANAGEMENT
9.1 GSK will manage all communications with in the Territory and pass
Manufacturing related customer complaints to ALLERGAN for
investigation and testing.
9.2 ***
9.3 ***
9.4 Complaints that indicate an Adverse Drug Experience has occurred shall
be communicated and resolved in accordance with the Pharmacovigilance
Agreement.
10. STABILITY PROGRAM
10.1 ALLERGAN will conduct an ongoing stability program in accordance with
a validated procedure including storage conditions and testing
protocols for the Product necessary to meet the requirements of cGMP,
Regulatory Approvals and applicable law. ICH storage conditions will
be used, unless agreed otherwise by the parties.
10.2 Where Change Control identifies a need for additional supporting
stability data on validation batches, ALLERGAN will consult with GSK
on any additional programme and testing protocols.
10.3 Any non-conforming stability results or adverse trends must be
reviewed by ALLERGAN in a timely manner and if confirmed, ***
11. ANNUAL PRODUCT QUALITY REVIEWS
11.1 ALLERGAN will conduct an Annual Product Quality Review for each
Product in the Territory on an annual basis ***. GSK and ALLERGAN
shall agree on the format, content and schedule for Annual Product
Quality Review reports. ALLERGAN will review the data and identify to
GSK changes or improvements that ALLERGAN believes may be desirable as
part of the Annual Product Quality Review report.
11.2 GSK will review the data supplied and may make recommendations with
respect to any changes/improvements that GSK believes are necessary or
desirable. Any such changes
*** 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 Exchange Act
of 1934, as amended.
or improvements adopted by ALLERGAN shall be implemented under
appropriate Change Control procedures.
11.3 Items to be covered by the Annual Product Quality Review typically
include, but are not limited to, changes to facilities, equipment,
process or specification, non-conformances, complaints, rejections,
reworks, Product returns, recalls, trends in key control parameters,
summaries and trends of stability data, and summaries of validation
activities.
*** 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 Exchange Act
of 1934, as amended.
EXHIBIT G
EXAMPLE OF PRICE ADJUSTMENT AND RECONCILIATION PROCESS
YEAR ONE YEAR TWO YEAR THREE YEAR FOUR YEAR FIVE
-------- -------- ---------- --------- ---------
*** *** *** *** ***
*** 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 Exchange Act
of 1934, as amended.
EXHIBIT H
ETHICAL STANDARDS AND HUMAN RIGHTS
(A) ALLERGAN does not employ engage or otherwise use any child labour in
circumstances such that the tasks performed by any such child labour could
reasonably be foreseen to cause either physical or emotional impairment to
the development of such child;
(B) ALLERGAN does not use forced labour in any form (prison, indentured, bonded
or otherwise) and staff are not required to lodge papers or deposits on
starting work;
(C) ALLERGAN provides a safe and healthy workplace, presenting no immediate
risks to its staff. Any housing provided by ALLERGAN to its workers is safe
for habitation. ALLERGAN provides access to clean water, food, and
emergency healthcare to its workers in the event of accidents or incidents
at ALLERGAN's workplace;
(D) ALLERGAN does not discriminate against any worker on any ground (including
race, religion, disability or gender). ALLERGAN does not engage in or
support the use of corporal punishment, mental, physical, sexual or verbal
abuse and does not use cruel or abusive disciplinary practices in the
workplace;
(E) ALLERGAN pays each employee at least the minimum wage, or a fair
representation of the prevailing industry wage, (whichever is the higher)
and provides each employee with all legally mandated benefits;
(F) ALLERGAN complies with the laws on working hours and employment rights in
the countries in which it operates;
(G) ALLERGAN does not engage in any activities which may cause health and
safety harm to those living in the vicinity to its operations; and
(H) ALLERGAN is responsible for controlling its own supply chain and agrees
that it shall encourage compliance with ethical standards and human rights
by any subsequent supplier of goods or services used in the Manufacture of
the Product.
*** 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 Exchange Act
of 1934, as amended.
