Exhibit 10.27
Certain portions of this Exhibit have been
omitted pursuant to a request for confidentiality. Such
omitted portions, which are marked with brackets [ ]
and an asterisk*, have been separately filed with the
Commission.
ELAN PHARMA INTERNATIONAL LIMITED
AND
ACORDA THERAPEUTICS, INC,
ZANAFLEX SUPPLY AGREEMENT
Certain portions of this Exhibit have been
omitted pursuant to a request for confidentiality. Such
omitted portions, which are marked with brackets [ ]
and an asterisk*, have been separately filed with the
Commission.
THIS SUPPLY AGREEMENT
(this “Agreement”
) is made on July 21, 2004 (the “Effective
Date” )
BETWEEN:
(1)
ELAN PHARMA INTERNATIONAL LIMITED, a company incorporated in
Ireland (registered no. 222276) (“Elan”);
and
(2)
ACORDA THERAPEUTICS, INC., a Delaware corporation whose
registered office is at 15 Skyline Drive, Hawthorne, NY 10532
(“Buyer”).
RECITALS:
(A)
Pursuant to
that certain Asset Purchase Agreement between Buyer and Elan
Pharmaceuticals, Inc. ( “EPI” ), dated
July 21, 2004 (the “Purchase Agreement” ),
Buyer acquired (among other assets) the rights and authorisations
necessary to market and sell the Products (as defined below) in the
Territory (as defined in the Asset Purchase Agreement).
(B)
Elan has agreed to manufacture and supply the Products to Buyer,
and Buyer has agreed to purchase the Products for onward commercial
supply on the terms and conditions set out in this
Agreement.
NOW IT IS HEREBY AGREED AS
FOLLOWS:
1.
INTERPRETATION
1.1
In this Agreement:
“Affected
Item” shall have
the meaning given to such term in Clause 10.3;
“Affected
Obligation” shall
have the meaning given to such term in Clause 20.1;
“Affected
Party” shall have
the meaning given to such term in Clause 20.1;
“Affiliate” shall mean, with respect to any person or
entity, any other person or entity which Controls, is Controlled by
or is under common Control with such person or entity;
“Alternate
Manufacturer” shall
have the meaning given to such term in Clause 11.4;
“Beneficiary”
shall have the meaning given to such
term in Clause 13.8.2;
“Business
Day” shall mean a
day other than a Saturday or Sunday or public holiday in England
and Wales, and Ireland;
“cGMP”
shall mean current Good
Manufacturing Practice under the applicable laws and regulations in
the United States, Ireland and the European Union;
Certain portions of this Exhibit have been
omitted pursuant to a request for confidentiality. Such
omitted portions, which are marked with brackets [ ]
and an asterisk*, have been separately filed with the
Commission.
“Confidential
Information” shall
have the meaning given to such term in Clause 15.1;
“Control”
means (a) ownership (directly
or indirectly) of at least fifty percent (50%) of the shares of
stock entitled to vote for the election of directors in the case of
a company or corporation; or (b) the ability (directly or
indirectly) otherwise to direct and control the actions of a person
or entity.
“Covenantor” shall have the meaning given to such term in
Clause 13.8.2;
“Disclosing
Party” shall have
the meaning given to such term in Clause 17.1;
“Due Date”
shall have the meaning given to such
term in Clause 9.4;
“Elan’s
Facility” shall
mean Elan’s manufacturing facility located at Monksland,
Athlone, Co. Westmeath, Ireland or Elan’s Affiliate’s
manufacturing facility located at Gainesville, Georgia, U.S.A., or
such other manufacturing facility as Elan may from time to time
specify (provided that any facility so specified has received all
required Facility Licences and Elan has provided Buyer with advance
notice sufficient to amend its NDA to include such facility if Elan
intends to use a facility other than the one located at Monksland,
Athlone, described above);
“Ex Works”
and “EXW” shall
have the meaning as such term is defined in the ICC Incoterms,
2000, International Rules for the Interpretation of Trade
Terms, ICC Publication No. 560;
“Facility
Licences” means all
required licenses, approvals, permits and authorizations required
by any Governmental Authority or law or regulation to manufacture,
package or store Products, or, to the extent required for Elan to
perform under this Agreement, to ship or export
Products;
“Force Majeure
Event” means an
event beyond the control of the Affected Party which makes the
Affected Party’s performance of an obligation impossible (or
such an event that makes such performance so impractical as to be
reasonably to be considered impossible) including, without
limitation, strike, lock-out, labour dispute, act of God, war,
armed conflict, terrorism, riot, civil commotion, malicious damage,
explosion, earthquake, fire, flood, storm or other extraordinary
adverse weather conditions.
“Governmental
Authority” shall
mean each governmental and regulatory body, agency, department or
entity, whether or not located in the Territory, which regulates,
directs or controls commerce in or with any territory or
location;
shall mean the Irish consumer
price index or such other index as may replace it from time to
time; or if there is no replacement, such published Irish index as
Elan in its discretion considers to be the closest comparator to
the same;
“Initial
Term” shall have
the meaning given to such term in Clause 11.1;
2
Certain portions of this Exhibit have been
omitted pursuant to a request for confidentiality. Such
omitted portions, which are marked with brackets [ ]
and an asterisk*, have been separately filed with the
Commission.
“Knowledge” of a particular fact or other matter
means: (i) with respect to any individual; (A) the
actual knowledge of such individual concerning such fact or other
matter; and (B) the knowledge that a prudent individual would
be expected to discover or otherwise become aware of in the course
of conducting a reasonable investigation concerning the existence
of such fact or other matter; and (ii) with respect to Elan or
Buyer, the Knowledge concerning such fact or other matter of
(1) the officers of such party, (2) the directors of such
party, and (3) the senior managers of such party with
responsibility for, or supervision of, the relevant matters;
provided that under no circumstances shall Knowledge of Elan
include any knowledge not actually known to such persons but
imputed to such persons or Elan due to its or its Affiliates’
relationship with Novartis Pharma AG (“Novartis”) or
its representatives; and provided, further, that none of such
persons shall have any obligation as a result of entering into (or
any provision of) this Agreement, the Purchase Agreement or any
related Agreement to make any inquiries of Novartis or its
representatives regarding any matter.
“Loss”
shall mean any loss, liability, or
cost (including reasonable attorneys’ fees and expenses)
which is incurred by a party;
“Medical
Claim” shall have
the meaning given to such term in Clause 13.7;
“Minor Deficiencies and
Delays” shall mean
(i) shortfalls that are consistent with industry accepted
standards, but not to exceed 10% of the amount ordered
(ii) delays in delivery of the Products not exceeding 30 days
from the delivery date or such other period of delay as may be
agreed between the Parties;
“Monthly Forecast
Report” shall have
the meaning given to such term in Clause 4.1.1;
“Production
Licence” shall have
the meaning given to such term in Clause 11.4;
“Products”
means pharmaceutical products
containing tizanidine as their active pharmaceutical ingredients
and having a multi-particulate capsule formulation currently
approved by the FDA pursuant to NDA No. 21-447 to be marketed
in the Territory.
“Product
Specifications” shall mean the specifications for the Products
contained in the relevant Regulatory Approvals issued by the
authorities in the Territory, and such additional or amended
specifications for such Products as may be effected under the terms
of this Agreement;
“Regulatory
Application” shall
mean any application for a Regulatory Approval, which is filed in
the Territory following the Effective Date, including any
supplements or amendments thereto;
“Regulatory
Approval” shall
mean the final approval required from a governmental regulatory
authority to market a Product in the Territory, and any other
approval which is required to market or sell such Product or
otherwise necessary for Buyer to perform under this Agreement or
otherwise handle the Products;
3
Certain portions of this Exhibit have been
omitted pursuant to a request for confidentiality. Such
omitted portions, which are marked with brackets [ ]
and an asterisk*, have been separately filed with the
Commission.
“Relevant
Claim” shall have
the meaning given to such term in Clause 13.8;
“Renewal
Term” shall have
the meaning given to such term in Clause 11.1;
“Serious Failure to
Supply” shall mean
that in a period of a calendar year, for reasons other than Force
Majeure, a shortage of tizanidine caused by events or third parties
not under the control of Elan, or the default of Buyer, Elan fails
on at least two consecutive occasions to supply Buyer’s
properly forecasted and ordered requirements of the Products in
accordance with the terms of this Agreement, except for Minor
Deficiencies and Delays, and the cumulative shortfall for such
calendar year attributable to such failure(s) is at least 35% of
the aggregate amount properly forecasted and ordered from Elan for
delivery in such calendar year; provided that, for purposes of this
definition the timely supply of Products that breach the
representations and warranties made in Clause 13.2 (excluding such
Products with nonlatent defects) will be deemed not to be a failure
to supply Buyer’s properly forecasted and ordered
requirements of the Products in accordance with the terms of this
Agreement;
“Specified Delivery
Date” shall have
the meaning given to such term in Clause 4.3;
“Technical
Agreement” shall
have the meaning given to such term in Clause 3.9;
“Technological
Competitors” shall
mean those entities, including any entities that are subsidiaries
or successors in interest to such entities, set out in
Schedule 3;
“Term”
shall mean the Initial Term plus any
applicable Renewal Term;
“Territory” means the United States of America, its
territories and possessions and the Commonwealth of Puerto
Rico;
“VAT”
means; (a) any tax
imposed in compliance with the Sixth Directive of the Council of
the European Economic Communities (77/388/EEC); and (b) any
other tax of a similar fiscal nature, whether imposed in a member
state of the European Union in substitution for or in addition to
such tax, or imposed elsewhere;
“VAT
Amount” shall have
the meaning given to such term in Clause 10.2; and
“$”
and “US$” shall
mean United States Dollars.
1.2
In this Agreement a reference to:
1.2.1
the singular includes the plural and vice versa;
1.2.2
a “person”
includes a
reference to a corporation, corporate body, association or
partnership;
1.2.3
any reference to a “Clause” or “Schedule” , unless the context
otherwise requires, is a reference to a clause or schedule of
this Agreement; and
4
Certain portions of this Exhibit have been
omitted pursuant to a request for confidentiality. Such
omitted portions, which are marked with brackets [ ]
and an asterisk*, have been separately filed with the
Commission.
1.2.4
any person shall (where appropriate), in respect of any provisions
relating to VAT, be deemed at any time when such person is a member
of a group for the purposes of section 43 to 43C of the Value
Added Tax Act 1994 (or in relation to a jurisdiction other than the
United Kingdom, such legal term or concept as most closely
corresponds to it) to include a reference to the representative
member (or in relation to a jurisdiction other than the United
Kingdom, such legal term or concept as most closely corresponds to
it) of such group at such time.
1.3
The headings of this Agreement are for ease of reference only and
shall not affect its construction or interpretation.
1.4
In this Agreement, the expressions “include” , “includes” and “including” shall be construed without
limitation.
2.
EXCLUSIVE SUPPLY
2.1
During the Term, subject to Clause 11.4, (Buyer shall purchase
all of its (and its Affiliates) requirements of the Products in the
Territory exclusively from Elan, and Elan shall supply all such
Products under the terms of this Agreement.
3.
REGULATORY MATTERS
3.1
Following the transfer of the Regulatory Approvals to Buyer
pursuant to the terms of the Purchase Agreement, Buyer shall (at
its own expense) be responsible for obtaining and maintaining all
Regulatory Approvals for the Products with the appropriate
Governmental Authority. Subject and pursuant to the
provisions of the Purchase Agreement and Interim Services Agreement
between EPI and Buyer, Elan shall provide all information and
assistance reasonably requested by Buyer needed to transfer and
obtain such Regulatory Approvals.
3.2
Each of Elan and Buyer shall, without delay, provide to the other
party such copies of all Regulatory Approvals, Regulatory
Applications, Facility Licenses and communications with any
Governmental Authority to the extent necessary for such other party
to comply with its obligations under this Agreement.
3.3
Elan shall, at Elan’s expense, be responsible for obtaining
and maintaining any and all export or import licences or clearances
relating to the raw materials and any other intermediary products
contained in the Products, together with any and all Facility
Licenses. Elan shall provide Buyer copies of all such
Facility Licenses at Buyer’s request. Elan shall ensure
that each Elan Facility complies with all laws, regulations and
licensing requirements applicable to the manufacture of Products in
compliance with the Product Specifications and cGMP. At the
request of Buyer, Elan shall take the steps necessary to qualify
its Affiliate’s Gainesville, Georgia, U.S.A. facility to
manufacture the Product, including but not limited to obtaining all
required Facility Licenses; provided that
5
Certain portions of this Exhibit have been
omitted pursuant to a request for confidentiality. Such
omitted portions, which are marked with brackets [ ]
and an asterisk*, have been separately filed with the
Commission.
all reasonable
costs of Elan, its Affiliates or its consultants actually incurred
in connection with such qualifications shall be borne by Buyer (as
long as such costs are approved by Buyer in advance, such approval
not to be unreasonably withheld or delayed).
3.4
Buyer shall promptly provide to Elan the packaging and related
artwork for the Products, which packaging and artwork must comply
with the relevant Regulatory Approvals. Buyer shall be
responsible for granting final approval of the pre-press proofs of
such artwork.
3.5
Buyer shall be responsible for obtaining and maintaining any
necessary export or import licences or clearances in respect of the
Products. Elan shall provide to Buyer reasonable assistance
and any documents in its possession which are reasonably necessary
for that purpose.
3.6
Each party shall notify the other party as soon as possible (and in
no event later than 48 hours) of any notification received by
it from a Governmental Authority to conduct an inspection of the
facilities used hereunder in the development, manufacturing,
packaging, storage or handling of the Products. Each party
shall promptly provide to the other party copies of all
correspondence with a Governmental Authority relating to any such
notification or inspection received or sent by it to the extent
that such correspondence relates to the Products. Each party
shall have a duty to reasonably cooperate with the other party with
respect to such inspections at such other party’s
facilities.
3.7
Upon reasonable request, Elan shall make that portion of its
facility where the Products are manufactured, tested or stored,
including all record and reference samples, available for
inspection:
3.7.1
upon reasonable notice and during normal business hours, by
Buyer’s duly qualified employee or, with the consent of Elan
(not to be unreasonably withheld or delayed), by Buyer’s duly
qualified agent or contractor; or
3.7.2
by a relevant Governmental Authority.
An inspection under
Clause 3.7.1 shall be limited to determining whether there is
compliance with cGMP and other requirements of applicable
law.
3.8
To the extent that any or all of the raw materials or intermediary
products contained in the Products are not produced by Elan, Elan
shall ensure that such materials or products are suitable for
manufacturing the Products in compliance with applicable Regulatory
Approvals, Facility Licenses and the Product Specifications and
meet all other applicable legal and regulatory
requirements.
3.9
As soon as is practicable after the Effective Date. Elan and
Buyer shall enter into a mutually-agreeable technical agreement
(the “Technical Agreement”) relating
6
Certain portions of this Exhibit have been
omitted pursuant to a request for confidentiality. Such
omitted portions, which are marked with brackets [ ]
and an asterisk*, have been separately filed with the
Commission.
to quality
assurance, acceptance testing and other requirements to be agreed
by the parties.
4.
FORECASTS AND ORDERS
4.1
In order to permit Elan to allocate its manufacturing capacity and
to assist Buyer with its sales and marketing, Buyer shall provide
Elan with bona fide written forecasts of its requirements for each
of the Products as follows:
4.1.1
By thirty (30) days after the Effective Date, and thereafter each
calendar month not later than the 23rd of the month, an 18-month
forecast (commencing at the beginning of the following month),
broken down by month (each, a “Monthly Forecast Report”
);
and
4.1.2
not later than 1 July in each year, a two-year forecast,
broken down by year.
4.2
The aggregate amount of Products forecasted to be required in the
first twelve (12) months of each Monthly Forecast Report shall,
unless otherwise agreed by Elan, not increase or decrease by more
than twenty-five percent (25%) as compared to the first twelve (12)
months of the forecast three months prior; provided, however, that
until there exists a Monthly Forecast Report from three months
prior to the then-current Monthly Forecast Report, the initial
Monthly Forecast Report shall be used for purposes of such
comparison.
4.3
Buyer shall be bound to order one hundred percent (100%) of the
forecast required quantities of the Products in each respective
month of the period of five (5) months immediately following
each Monthly Forecast Report, but otherwise forecasts shall not be
binding. With respect to such orders, Buyer shall submit to
Elan a written purchase order for such required quantities of
Products, specifying the order quantity and the date on which
delivery of the order is required (the “Specified Delivery
Date,” which shall in no event be earlier than one hundred
fifty (150) days after the date of Elan’s receipt of such
written purchase order). For the avoidance of doubt, the
parties acknowledge and agree that, notwithstanding anything to the
contrary contained in this Agreement, other than pursuant to the
preceding two sentences Buyer shall not be obligated to place any
minimum number of orders under this Agreement.
4.4
Elan shall not be obligated to supply Products in excess of
Buyer’s requirements as forecast in accordance Clauses 4.1,
4.2 and 4.3.
4.5
Notwithstanding Clauses 4.1, 4.2, 4.3 and 4.4, Elan will use its
commercially reasonable efforts to fulfill Buyer’s
requirements in excess of forecasted amounts.
4.6
The order quantity shall be in whole number multiples of the
minimum batch size of the Products, which minimum batch size shall
be as set out in Schedule 1;
7
Certain portions of this Exhibit have been
omitted pursuant to a request for confidentiality. Such
omitted portions, which are marked with brackets [ ]
and an asterisk*, have been separately filed with the
Commission.
provided,
however, that upon the request of Buyer, Elan will discuss with
Buyer in good faith the reduction of minimum batch sizes set out in
Schedule 1 (and any related amendment to Schedule 1); and
provided, further, that all reasonable costs of Elan, its
Affiliates or its consultants actually incurred in connection with
the reduction of such minimum batch sizes shall be paid by Buyer
(as long as such costs are approved by Buyer in advance, such
approval not to be unreasonably withheld or delayed). Elan
shall have the right to refuse to fulfil any amount of an order
which does not conform with the provisions of this Clause
4.6. Where Elan in its sole discretion fulfils any order
which does not conform with the provisions of this Clause 4.6, the
fulfilment of such order by Elan shall not affect Elan’s
right to refuse to fulfil any subsequent order which does not
conform with the provisions hereof.
4.7
Buyer hereby agrees that it shall not use Products delivered to
Buyer in bulk capsule form for packaging into finished Products for
commercial sale.
4.8
To the extent that at any time during the Term Buyer notifies Elan
of its intention to sell finished Products that Buyer is then
holding in inventory as “safety stock”, (a) all
then current purchase orders shall remain in place, and
(b) Elan agrees to discuss in good faith with Buyer the
modification of the Monthly Forecast Report most recently submitted
by Buyer (including disregarding the provisions of Clause 4.2 with
respect thereto).
4.9
The terms of this Agreement are hereby incorporated by reference
into each written purchase order for Products submitted by Buyer
and accepted by Elan. In the event of any conflict between an
order or other written instructions and this Agreement, the terms
of this Agreement shall prevail.
5.
SUPPLY OF THE PRODUCTS
5.1
Elan shall supply the Products requested in each written purchase
order by the Specified Delivery Date (subject to the 30-day cure
period specified in Clause 11.2.1).
5.2
Each Product supplied by Elan to Buyer shall:
5.2.1
be in final market packaging in accordance with written standards
agreed by the parties from time to time;
5.2.2
be Ex Works Elan’s Facility;
5.2.3
be free from any liens or encumbrances;
5.2.4
conform to, and be manufactured in accordance with, the relevant
Product Specifications and all applicable laws and regulations,
including applicable cGMP;
8
Certain portions of this Exhibit have been
omitted pursuant to a request for confidentiality. Such
omitted portions, which are marked with brackets [ ]
and an asterisk*, have been separately filed with the
Commission.
5.2.5
be in suitable packaging in a sealed tamper-evident container and
labelled in accordance with Buyer’s reasonable requirements
communicated to Elan, in particular as required pursuant to any
Regulatory Approval and so as to permit safe storage and transport;
and
5.2.6
be accompanied by a certificate of analysis and a certificate of
release, in each case in a form conforming to industry standards as
mutually agreed between Elan and Buyer.
6.
CHANGES TO PRODUCT SPECIFICATIONS
6.1
If:
6.1.1
changes to the Product Specifications are required by law or by any
Governmental Authority; or
6.1.2
Buyer reasonably requests changes to the Product
Specifications;
Elan shall promptly implement any
such changes at Buyer’s sole cost (such cost to include but
not be limited to Elan’s internal and external costs relating
to changes to artwork and labeling and changes to raw materials,
intermediary products and components, in each case whether such
costs are out-of-pocket costs or write-off charges (to the extent
such write-off charges are actually incurred by Elan and Elan has
attempted in good faith to avoid such write-off charges by making
other use of the applicable materials, products or components);
provided, that Elan shall provide Buyer with advance notice of such
changes and the estimated costs thereof and Buyer shall have the
opportunity to discuss with Elan any of such changes or costs prior
to such changes being implemented for up to two (2) weeks
after Buyer receives such notice; and, provided, further, that with
respect to then-outstanding purchase orders submitted by Buyer
pursuant to Clause 4.3, to the extent that applicable law or any
Governmental or Regulatory Authority does not allow Elan to
manufacture and deliver to Buyer, or Buyer to sell, Products
ordered under such purchase orders, Elan shall be permitted to
delay delivery of Products ordered thereunder for an amount of time
equal to the actual delay in making the changes required by changes
in Product Specifications caused by compliance with this Clause 6.1
(it being understood and agreed by Buyer that it shall accept
Products ordered under such purchase orders despite such Products
being manufactured to Product Specifications that do not reflect
the changes required by this Clause 6.1, to the extent that
applicable law or any Governmental or Regulatory Authority allows
Elan to manufacture and deliver to Buyer, and Buyer to sell, such
Products). Otherwise, changes shall only be made to the
Product Specifications by agreement between the parties.
9
Certain portions of this Exhibit have been
omitted pursuant to a request for confidentiality. Such
omitted portions, which are marked with brackets [ ]
and an asterisk*, have been separately filed with the
Commission.
7.
DISPUTES AS TO SPECIFICATIONS
7.1
All claims for failure of any Product to conform to the Product
Specifications must be made by Buyer in writing within sixty (60)
days following delivery, except in the case of latent
defects. Claims for latent defects, not discovered during the
routine testing protocol (which is to be agreed between the parties
reasonably and in good faith), shall be made in writing within
forty-five (45) days of discovery. Except as described in the
preceding sentence, failure to make timely claims in the manner
prescribed in this Clause 7.1 shall constitute acceptance of the
delivery.
7.2
Where Products which have been delivered breach the representations
and warranties made in Clause 13.2 (and Clause 7.1 has been
complied with) and such non-conformity is attributable to acts or
omissions of Elan:
7.2.1
they shall be reworked (to the extent permitted by applicable law)
or replaced at Elan’s cost within ninety (90) days of the
receipt by Elan of the non-conforming Products; and
7.2.2
Elan shall reimburse Buyer in respect of the costs incurred by
Buyer in relation to any testing, handling, destruction or return
of the Products.
Notwithstanding Clause 11.2.1, no
cure period shall apply with respect to Products described in
Clause 7.2 other than that set forth in Clause 7.2.1. Other
than as expressly set forth elsewhere in this Agreement in Clause
13.6, and with respect to Serious Failures to Supply and Product
recalls, Buyer shall have no remedies in respect of Elan having
supplied Products that breach the representations and warranties
made in Clause 13.2 other than as set out in this Clause
7.2.
7.3
In the event of an unresolved dispute:
7.3.1
as to conformity of a Product with the relevant Product
Specifications pursuant to Clause 7.1 or 8.3; or
7.3.2
pursuant to clauses 8.5 or 13.4,
the parties shall appoint an
independent first-class laboratory or other appropriate,
independent expert to undertake the relevant testing, and its
findings shall be conclusive and binding upon the parties. If
the parties fail to agree on the appointment of an independent
first-class laboratory or expert, as appropriate, within thirty
(30) days after the parties first discuss such appointment, the
parties agree that an independent party designated by Elan and an
independent party designated by Buyer shall together select a
mutually-acceptable, appropriate, independent expert. Such
independent expert shall undertake the relevant analysis and/or
testing and report its findings within a reasonable time
of
10
Certain portions of this Exhibit have been
omitted pursuant to a request for confidentiality. Such
omitted portions, which are marked with brackets [ ]
and an asterisk*, have been separately filed with the
Commission.
appointment, which findings shall be
conclusive and binding upon the parties. All costs relating
to this process shall be borne solely by the unsuccessful
party.
8.
ADVERSE EVENTS AND PRODUCT RECALL
8.1
Each party shall, without delay, give notice to the other of any
occurrence that involves:
8.1.1
any complaint about the safety, quality, packaging or effectiveness
of a Product manufactured or supplied under this Agreement,
including a claim for death or injury following administration of
such Product (that is allegedly related to the administration of
such Product); and
8.1.2
any other matter in connection with a Product manufactured or
supplied under this Agreement or arising out of this Agreement that
must be reported to a Governmental Authority.
8.2
The parties agree that within sixty (60) days following the
Effective Date, representatives of each party with responsibility
for the safety, surveillance and pharmacovigilance of the Products
shall meet to develop detailed procedures regarding the format,
timing and content of the safety information to be exchanged
between the parties, and shall meet periodically thereafter to
update the procedures.
8.3
If a party:
8.3.1
is notified by a Governmental Authority that a recall of a Product
is required, requested or otherwise advisable; or
8.3.2
establishes a need to recall a Product for non-conformity with the
Product Specifications,
it shall promptly give to the other
party notice of the same with full details. Notwithstanding
any dispute between the parties as to whether the Product complies
with the Product Specifications, the recall shall commence but such
dispute shall be resolved in accordance with Clause 7.3.
8.4
Unless otherwise agreed or unless Elan elects to take over and
perform the recall of the Product pursuant to Clause 8.6.2, Buyer
shall take the lead/coordinating role in any recall of the Product
in a commercially reasonable manner, and Elan shall afford all
reasonable assistance to Buyer in respect of such recall. A
joint recall administration team shall be established to support
Buyer in such role with an equal number of nominated individuals
from each party participating. A final report shall be
completed by the recall administration team and delivered promptly
to both parties.
11
Certain portions of this Exhibit have been
omitted pursuant to a request for confidentiality. Such
omitted portions, which are marked with brackets [ ]
and an asterisk*, have been separately filed with the
Commission.
8.5
The costs of a recall of the Product, including the cost of
replacement quantities of such Product, shall be borne by Buyer
unless (a) the recall arises from Elan’s supply of
Product that breach the representations and warranties made in
Clause 13.2 or from the negligent acts or omissions of Elan in
manufacturing the Product, and (b) subject to Clause 13.6,
Buyer could not have discovered such failure or acts or omissions
prior to the sale of the Product by exercising reasonable diligence
in conducting acceptance testing pursuant to the Technical
Agreement, in which case Elan shall bear the actual costs of the
recall; provided that each party hereby agrees to use commercially
reasonable efforts to minimize any costs relating to any recall of
the Product that may be borne by the other party. If the
parties are unable to agree who should bear the cost of the recall,
the dispute shall be settled in the manner set forth in Clause
7.3.
8.6
In the event that Elan is required to bear the costs of any recall
of the Product in accordance with Clause 8.5, Elan
shall:
8.6.1
reimburse Buyer for all reasonable and actual costs and expenses
which Buyer incurs in connection with such recall; and
8.6.2
be entitled (but not obliged) to take over and perform the recall
of such Product.
9.
PRICE AND PAYMENT
9.1
The price of the Products shall be:
9.1.1
until the first anniversary of the Effective Date, the price set
out in Schedule 1;
9.1.2
thereafter, (and subject to Clause 9.2) at such price as Elan
notifies to Buyer from time to time, provided that during the Term
(including the Initial Term and any Renewal Term(s)) price
increases for the Products shall be limited to the percentage
increase in the Index, as compared to the most recent price
adjustment.
9.2
In addition to any price increases pursuant to Clause 9.1.2,
if:
9.2.1
the price which Elan must pay for the active ingredient of, or
other raw material used to produce, a Product increases by a
percentage in excess of the percentage increase in the Index (as
compared to the later of the Effective Date or the most recent
price adjustment pursuant to this Clause 9.2);
9.2.2
additional regulatory obligations are imposed on Elan by law or a
Governmental Authority; or
12
Certain portions of this Exhibit have been
omitted pursuant to a request for confidentiality. Such
omitted portions, which are marked with brackets [ ]
and an asterisk*, h