Exhibit 10.26
CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED AS "(CONFIDENTIAL TREATMENT
REQUESTED)" IN THE TEXT, 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.
SECOND AMENDED AND RESTATED
PRODUCTION AGREEMENT
BETWEEN
CARDINAL HEALTH 406, INC.
AND
MEDIMMUNE VACCINES, INC.
This
Second Amended and Restated Production Agreement (the
"Agreement" ) is made effective as of
December 31, 2003 (the "Effective Date" ) by and
between Cardinal Health 406, Inc., a Pennsylvania corporation
with offices at 3001 Red Lion Road, Philadelphia, Pennsylvania
19114 (hereinafter called "Cardinal Health" ); and
MedImmune Vaccines, Inc., a Delaware corporation with offices
at 35 West Watkins Mill Road, Gaithersburg, Maryland 20878
(hereinafter called "MedImmune" ). Cardinal Health
and MedImmune may be referred to herein as a " Party
" or, collectively, as " Parties ."
WITNESSETH
WHEREAS , Cardinal Health specializes in packaging for the
pharmaceutical industries and has certain technical and commercial
information and know-how relating to, among other things,
performing assembly functions and packaging of pharmaceutical
products.
WHEREAS , MedImmune is a corporation that develops,
registers, manufactures and markets pharmaceutical products, and is
the owner of certain proprietary technical and commercial
information and know-how relating to, among other things, the
formulation and development of such products.
WHEREAS , MedImmune desires to engage Cardinal Health to
provide certain services to MedImmune in connection with the
packaging of certain of MedImmune's products;
WHEREAS , Cardinal Health, formerly known as Packaging
Coordinators, Inc., and the predecessor-in-interest of
MedImmune, namely Aviron, a Delaware corporation, previously
entered into a Production Agreement, effective as of
October 31, 1997, providing for such packaging, and such
agreement was amended and restated effective as of August 1,
2000 (as so amended, the " First Amended and Restated
Production Agreement "); and
WHEREAS , the parties desire to reallocate the
responsibilities for such manufacture between them and to further
amend and restate the First Amended and Restated Production
Agreement in its entirety;
NOW, THEREFORE , in consideration of the premises and the
mutual promises contained herein and intending to be legally bound
hereby, the Parties agree as follows:
1.
DEFINITIONS
The following terms as used in this
Agreement shall have the meanings set forth in this Article unless
otherwise specifically provided herein:
1.1. "
Affiliate(s) " shall mean any corporation, firm,
partnership or other entity which controls, is controlled by or is
under common control with a Party. For purposes of this definition,
control shall mean the ownership of at least fifty (50%) percent of
the voting share capital of such entity or any other comparable
equity or ownership interest.
1.2. "
Agency " shall mean any governmental regulatory
authority involved in regulating any aspect of the development,
Manufacture, Storage and sale of the Product.
1.3 "
MedImmune Facility " shall mean the portion of the
Cardinal Health Facility that is subject to the Facility
Reservation Agreement and which is dedicated to Primary and
Secondary Production, or such other facility as my be mutually
agreed in writing by the Parties.
1.4 "
MedImmune Production Equipment " shall mean any
Secondary Production equipment purchased by MedImmune for use by
Cardinal Health pursuant to this Agreement.
1.5 "
cGMP " shall mean all the laws, regulations and
standards relating to Secondary Production, including but not
limited to, the United States Food And Drug Administration (FDA)
current Good Manufacturing Practices, as set forth in the Code of
Federal Regulations (CFR), and the EEC Good Manufacturing
Guidelines, Volume IV as such Regulations and Guidelines may be
revised from time to time, and any other applicable laws,
guidelines and regulation. If there should be a conflict between
the FDA and EEC standards, the more stringent of the two shall
apply. MedImmune shall be responsible to advise Cardinal Health of
cGMP and other Agency requirements which shall apply to Secondary
Production conducted hereunder.
1.6 "
Delivery Date " shall mean the date on which Product
is delivered from Cardinal Health to MedImmune pursuant to
Section 7.2.
1.7 "
Facility Reservation Agreement " shall mean that
certain agreement dated October 31, 1997, as amended from time
to time, relating to the build-out and use of the MedImmune
Facility.
1.8 "
FDA " shall mean the United States Food and Drug
Administration and any successor agency having substantially the
same function.
1.9 "
Materials " shall mean all components utilized in
Secondary Production except for the Primary Product.
1.10 "
Michigan " shall mean the Regents of the University
of Michigan, a constitutional corporation of the State of Michigan
with offices located at Wolverine Tower, Room 2071, 3003 South
State Street, Ann Arbor, Michigan, 48109-1280, USA.
1.11 "
Michigan Agreement " shall mean a certain Materials
Transfer and Intellectual Property Agreement between MedImmune and
Michigan dated 24 February 1995.
1.12 "
Packaging Specifications " shall mean the procedures,
Standard Operating Procedures, components specifications, test
results, requirements, quality standards data and other
documentation with respect to Materials, Secondary Production,
Product Production Equipment and Storage, including, without
limitation, those appended hereto as Appendix 2 , as
the same may be amended from time to time.
1.13 "
Cardinal Health Facility " shall mean Cardinal
Health's facility at 3001 Red Lion Road, Philadelphia,
Pennsylvania, or such other facility as may be mutually agreed in
writing by the Parties.
1.14 "
Cardinal Health Production Equipment " shall mean all
of the packaging, labeling and testing equipment purchased by
Cardinal Health as set forth in Appendix 1 , which may
be amended from time to time.
1.15 "
Primary Product " shall mean the product that is the
result of Primary Production.
1.16 "
Primary Production " shall mean the blending and
aseptic filling of Vaccine in a syringe.
1.17 "
Primary Product Specifications " shall mean the
procedures, Standard Operation Procedures, test results,
requirements, quality standards data and other documentation
developed by MedImmune with respect to Primary Product.
1.18 "
Product " shall mean the product which is the result
of Primary and Secondary Production.
1.19 "
Proprietary Information " shall have the meaning set
forth in Article 12.
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1.20 "
Secondary Area " shall mean the area at the MedImmune
Facility reserved for Secondary Production as designated by
MedImmune in consultation with Cardinal Health.
1.21 "
Secondary Production " shall mean assembly, labeling
and packaging of Primary Product and Storage, in accordance with
the Packaging Specifications.
1.22 "
Store " or " Storage " shall mean the
storage of Product, Materials and/or Stored Materials, as set forth
in the Packaging Specifications.
1.23 "
Stored Materials " shall mean all Materials, Syringes
and other supplies to be used by MedImmune in connection with
Primary Production (other than normal allantoic fluid and
vaccine).
1.24 "
Syringe " shall mean the unfilled sprayer and
stopper, as set forth in the Packaging Specifications.
1.25 "
Vaccine " shall mean the bulk cold-adapted influenza
vaccine, as set forth in the Packaging Specifications.
2.
REPLACEMENT OF FIRST AMENDED AND
RESTATED PRODUCTION AGREEMENT By
entering into this Agreement, the Parties hereby amend and restate
the First Amended and Restated Production Agreement in its
entirety. Except for rights and obligations accrued as of the
Effective Date, all rights and obligations arising thereunder are
hereby terminated as of the Effective Date.
3.
PRODUCTION EQUIPMENT
3.1.
Installation and Qualification.
Each Party will, at its sole expense,
provide, install in the Secondary Area, validate and qualify its
respective Production Equipment in compliance with cGMP. MedImmune
will perform process validation on the packaging line and Cardinal
Health will assist MedImmune in the validation process with its
operators and engineers.
3.2.
Maintenance.
Cardinal Health agrees to maintain and
operate the MedImmune and Cardinal Health Production Equipment used
for Secondary Production, in all material respects, in accordance
with (a) cGMPs, (b) applicable Agency requirements and
(c) the Packaging Specifications. As to the MedImmune
Production Equipment, Cardinal Health shall be responsible for
routine maintenance in accordance with the equipment manufacturers'
guidelines, cGMPs and other applicable laws and regulations, and
for other repairs required as a result of the negligence or
intentional misconduct of Cardinal Health or its employees.
MedImmune shall bear all other expenses incurred for the
maintenance (other than routine maintenance), repair and/or
replacement, of the MedImmune Production Equipment. MedImmune shall
be responsible for all expenses and maintenance (including routine
maintenance) for any other equipment, used in Primary Production,
including, without limitation, the freezer, but not including, in
any case, the building equipment required to be maintained by
Cardinal Health pursuant to the Facility Reservation Agreement. For
the purpose of this Agreement, routine maintenance shall mean
preventive maintenance and calibration, as set forth in the
Packaging Specification.
3.3.
Ownership
. MedImmune shall at all times hold all
right, title and interest in the MedImmune Production Equipment.
Cardinal Health shall not, at any time during the term of this
Agreement, encumber the MedImmune Production Equipment. Cardinal
Health shall at all times hold all right, title and interest in the
Cardinal Health Production Equipment. MedImmune shall not, at any
time during the term of this Agreement, encumber the Cardinal
Health Production Equipment. Upon the other Party's request, each
Party shall provide evidence to the other Party's reasonable
satisfaction indicating that Party's Production Equipment is
insured and that such insurance covers the other Party (as an
additional insured) for any loss or damage to the other Party, or
its property or employees, except where such loss or damage is a
result of the negligence or intentional misconduct of the other
Party or its employees.
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3.4.
Changes to Equipment
. As it relates to Secondary Production,
neither Party may modify, alter or otherwise use different
equipment other than that Party's Production Equipment without the
written consent of the other Party. The costs for any approved
changes to a Party's Production Equipment, including, but not
limited to, changes requiring validation or other associated costs,
will be borne by the Party making the request, except as otherwise
agreed upon by the Parties. Validation or re-validation of
Production Equipment after a change under this Section 3.4
will be performed by the owner of the Production Equipment subject
to the reasonable approval of the other Party and such other
conditions as the Parties may agree upon before implementing the
proposed change.
4.
COORDINATION; SUPERVISION WITHIN THE
SECONDARY AREA
4.1.
MedImmune Technical Representative
. MedImmune shall have the right to have one
or more representatives in the Secondary Area during Secondary
Production to (a) review Production Equipment and Secondary
Production, (b) review any relevant records in connection with
such Secondary Production and assess its compliance with cGMP and
quality assurance standards set forth in the Packaging
Specifications and (c) discuss any related issues with
Cardinal Health's management. MedImmune's technical
representatives, when in the Secondary Area, shall comply with
Cardinal Health's rules and regulations. MedImmune shall indemnify
and hold Cardinal Health and its Affiliates harmless from all
liability, including claims by MedImmune's technical
representatives for workers' compensation, resulting from the
presence of MedImmune's technical representatives at the MedImmune
Facility except for claims resulting from the negligent or willful
misconduct on the part of Cardinal Health and its employees or
breach by Cardinal Health of its obligations hereunder or under the
Facility Reservation Agreement.
4.2.
Responsibilities
. MedImmune's technical representative, if
present, shall not have responsibility for the supervision of
Cardinal Health's personnel conducting Secondary Production.
However, if at any time MedImmune's technical representatives feel
that Cardinal Health is operating in a manner inconsistent with
this Agreement, he/she is to notify Cardinal Health immediately to
cease operations until such condition is remedied. Cardinal Health
will immediately cease operations and will not recommence Secondary
Production operations without MedImmune's approval. Cardinal Health
shall use its best efforts to remedy any such condition and
MedImmune shall authorize Cardinal Health to resume Secondary
Production upon reasonable satisfaction that such condition has
been remedied. Nothing herein shall amend or alter the status of
Cardinal Health as an independent contractor.
4.3.
Coordination of Primary and Secondary
Production . MedImmune and Cardinal
Health shall mutually agree in writing upon and arrange for each of
the following activities and any additional activities that are
necessary or useful to permit MedImmune to undertake Primary
Production at the MedImmune Facility or to permit the Parties to
coordinate Primary Production with Secondary Production:
(a) Provision
for the delivery of materials and equipment for Primary
Production;
(b) Transfer
of Primary Product at designated times from MedImmune to Cardinal
Health in a manner that ensures Storage in compliance with the
Packaging Specifications at all times;
(c) Delivery
of Product pursuant to Section 7.2 in a manner that ensures
Storage in accordance with the Packaging Specifications;
(d) Communication
as to other issues arising from MedImmune's conduct of Primary
Production, Cardinal Health's conduct of Secondary Production,
other activities of Cardinal Health at the MedImmune Facility
pursuant to the Facility Reservation Agreement, or coordination of
Primary and Secondary Production; and
(e) Designation
of a representative of each party to coordinate and facilitate the
activities of (a) to (d).
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5.
FORECAST, PURCHASE AND SUPPLY OF
PRODUCT
5.1.
Secondary Production
. During the term of this Agreement,
Cardinal Health shall perform Secondary Production of such
quantities of Product as may be set forth on orders placed by
MedImmune under this Agreement. All Secondary Production and
deliveries of Product hereunder shall be governed by the terms of
this Agreement which shall supersede any inconsistent provisions in
any order delivered by MedImmune to Cardinal Health.
5.2.
Forecasts
. On or before (CONFIDENTIAL TREATMENT
REQUESTED) of each year during the term of this Agreement,
MedImmune will provide Cardinal Health with a written (CONFIDENTIAL
TREATMENT REQUESTED) forecast, to be updated in (CONFIDENTIAL
TREATMENT REQUESTED) intervals, of the quantity of Product which
MedImmune expects to require form Cardinal Health during each of
the next (CONFIDENTIAL TREATMENT REQUESTED). The first
(CONFIDENTIAL TREATMENT REQUESTED) of the first such rolling
forecast shall be binding upon MedImmune, subject to the provisions
of Section 5.6 below. MedImmune's first forecast shall include
(a) the required Delivery Date for the binding portion of the
forecast and (b) the quantity of Product to be
delivered.
5.3.
Orders
. According to the forecast, MedImmune will
provide Cardinal Health with one or more orders at (CONFIDENTIAL
TREATMENT REQUESTED) intervals. Each such order will set forth
(a) the quantity of Product ordered for delivery during the
(CONFIDENTIAL TREATMENT REQUESTED) after the date on which the
order is deemed to be received, (b) the requested Delivery
Date for such order, (c) the quantity of Product to be
delivered to MedImmune as a quality control sample and (d) the
quantity of Product to be delivered on the Delivery Date in each
form of packaging. Such order shall be delivered no later than
(CONFIDENTIAL TREATMENT REQUESTED) days prior to the earliest
requested Delivery Date.
5.4.
Confirmation; Orders Greater than
Forecast . Within fifteen (15) days
of receipt of any order, Cardinal Health shall confirm in writing
such order and the Delivery Date therefore. Cardinal Health shall
use reasonable commercial efforts to supply the quantity of Product
ordered, regardless of the quantity forecast by MedImmune, subject
to the capacity limitations of the MedImmune and Cardinal Health
Production Equipment and to the ability of MedImmune to supply
Primary Product to Cardinal Health pursuant to Section 6.2. In
the event that Cardinal Health is unable to fill any order,
Cardinal Health shall so notify MedImmune in its written
confirmation.
5.5.
Amendment of Orders
. Cardinal Health will use best efforts to
accommodate a request to amend an order to increase or decrease the
quantity of Product to be delivered.
5.6.
Cancellations
. MedImmune may cancel any order by
providing Cardinal Health written notice at any time prior to the
confirmed Delivery Date. In the event that MedImmune cancels any
order for Product, MedImmune shall pay Cardinal Health at the rates
set forth in Section 13.1 for (CONFIDENTIAL TREATMENT
REQUESTED) Cardinal Health in connection with performance of such
order up to the time of receipt of such notice, including, without
limitation, (CONFIDENTIAL TREATMENT REQUESTED) prior to the
confirmed Delivery Date, based upon MedImmune's binding forecast
(as set forth in Section 5.2 above).
5.7.
Supply Commitments
. Subject to the limitations set forth in
Section 5.4, Cardinal Health represents and warrants that it
has the ability to, and hereby covenants that it will, supply the
quantity of Product ordered by MedImmune.
5.8.
Limited Warranty
. CARDINAL HEALTH WARRANTS THAT PRODUCT
DELIVERED HEREUNDER WILL (a) BE PACKAGED BY CARDINAL HEALTH IN
ACCORDANCE WITH cGMP AND OTHER APPLICABLE FEDERAL, STATE AND LOCAL
LAWS AND REGULATIONS, INCLUDING BUT NOT LIMITED TO FDA REGULATIONS,
(b) BE PACKAGED IN ACCORDANCE WITH THE PACKAGING
SPECIFICATIONS AND
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(c) CONFORM AS OF THE DELIVERY DATE TO THE
APPLICABLE PACKAGING SPECIFICATIONS, AS THEN IN EFFECT, SUBJECT TO
NONCONFORMITIES IN PRIMARY PRODUCT EXISTING AT THE TIME OF DELIVERY
TO CARDINAL HEALTH. EXCEPT AS SET FORTH HEREIN, CARDINAL HEALTH
MAKES NO WARRANTIES, EXPRESS OR IMPLIED, CONCERNING THE PRODUCTS,
INCLUDING WARRANTIES OF MERCHANTABILITY AND FITNESS FOR ANY
PARTICULAR PURPOSE.
6.
SUPPLY AND PROCESSING OF PRIMARY
PRODUCT, SYRINGES AND MATERIALS
6.1.
License; Inventions
.
(a) MedImmune
hereby grants to Cardinal Health, during the term of this
Agreement, a non-exclusive, non-transferable, royalty-free license
during the term of this Agreement to use the data, information and
technology provided by MedImmune related to the Vaccine and the
Primary Product for the limited purpose of assisting Cardinal
Health in carrying out its obligations set forth in this
Agreement.
(b) Cardinal
Health agrees that any and all idea, improvements, inventions and
works of authorship conceived, written or first reduced to practice
whether by Cardinal Health's employees alone or in conjunction with
MedImmune, if any, that are related to the Vaccine or Primary
Production (the " MedImmune Inventions ") shall be
the sole and exclusive property of MedImmune and Cardinal Health
hereby assigns to MedImmune all right, title and interest in and to
any and all such MedImmune Inventions.
(c) MedImmune
agrees that any and all ideas, improvements, inventions and works
of authorship conceived, written or first reduced to practice in
the performance of this Agreement that are related to Secondary
Production (the " Cardinal Health Inventions ") shall
be the sole and exclusive property of Cardinal Health and MedImmune
assigns all right, title and interest in and to any and all such
Cardinal Health Inventions. Cardinal Health hereby grants to
MedImmune a non-exclusive, worldwide, royalty-free license to use
and practice such Cardinal Health Inventions for the manufacture,
by or for MedImmune of any of MedImmune's products. Such license
shall survive the termination or expiration of this
Agreement.
6.2.
Supply of Primary Product
. MedImmune shall, at MedImmune's expense,
on a timely basis, deliver or cause to be delivered to the
Secondary Area or made available at the MedImmune Facility,
sufficient quantities of Primary Product meeting the Primary
Product Specifications such that Cardinal Health can fill orders
for the Product submitted pursuant to Section 5.3.
6.3.
Risk of Loss of Primary Product
.
(a) Subject
to the limitations set forth in Section 6.3(c) and
Section 9.2(a), Cardinal Health will bear risk of loss for
Primary Product delivered or made available to Cardinal Health
under Section 6.2 and for Stored Materials, which loss results
from Cardinal Health's failure to comply with the Packaging
Specifications or from the negligence or intentional misconduct of
Cardinal Health or its employees. Cardinal Health shall issue
MedImmune a credit for such losses for which Cardinal Health bears
the risk of loss as described in the preceding sentence. This
credit will be applied against any amounts owed Cardinal Health by
MedImmune at the time the credit is issued and to the extent the
credit exceeds the amount due, the remaining portion of the credit
will be carried over and applied to the next payments due to
Cardinal Health from MedImmune under this Agreement until all such
credits (or remainders) are exhausted. If the Agreement terminates
or expires and there is a credit remaining, Cardinal Health shall
apply such credit against any sums owed Cardinal Health by
MedImmune, and, to the extent there is a credit balance remaining,
shall pay MedImmune the difference.
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(b) Subject
to the limitations set forth in Section 6.3(c) and
Section 9.2(a), Cardinal Health will also bear the risk of
loss for normal manufacturing losses of commercial Primary Product
containing active ingredients ( i.e. excluding media fills)
("Commercial Primary Product") from the entire packaging line as it
exists on June 1, 2003, in excess of (CONFIDENTIAL TREATMENT
REQUESTED) of all Commercial Primary Product delivered or made
available to Cardinal Health by MedImmune during any Production
Year (as defined in Article 13). Losses shall not include
inspection booth rejects, quality assurance testing and challenges
and retained samples. If equipment is added to or removed from the
packaging line, the Parties shall negotiate a new normal
manufacturing loss percentage. Losses shall be calculated promptly
following the conclusion of the Production Year. At the conclusion
of each Production Year, Losses will be reviewed and the allowable
loss percentage adjusted accordingly. Cardinal Health shall issue
MedImmune a credit for such losses for which Cardinal Health bears
the risk of loss as described in the preceding sentences. This
credit will be applied against any amounts owed Cardinal Health by
MedImmune at the time the credit is issued and to the extent the
credit exceeds the amount due, the remaining portion of the credit
will be carried over and applied to the next payments due to
Cardinal Health from MedImmune under this Agreement until all such
credits (or remainders) are exhausted. If the Agreement terminates
or expires and there is a credit remaining, Cardinal Health shall
apply such credit against any sums owed Cardinal Health by
MedImmune, and, to the extent there is a credit balance remaining,
shall pay MedImmune the difference. The parties shall work together
to reduce manufacturing Losses.
(c) Cardinal
Health's liability for Primary Product losses under this Agreement,
including without limitation under Section 6.3(a),
Section 6.3(b) and Section 7.5 will not exceed
(CONFIDENTIAL TREATMENT REQUESTED) For lots equal to or exceeding
(CONFIDENTIAL TREATMENT REQUESTED), the cap on Cardinal Health's
liability for Primary Product losses set forth in the preceding
sentence will be $(CONFIDENTIAL TREATMENT REQUESTED). For less than
full lot quantities, those respective caps will be pro-rated.
MedImmune will bear all risk of loss and responsibility to insure
for losses of the Primary Product other than as such risk is
specifically assumed by Cardinal Health under this Agreement and
above loss limit set forth herein.
(d) The
Parties agree to work together on process improvements to improve
production efficiency and reduce packaging waste.
6.4.
Supply of Materials and Inventories
. Cardinal Health shall purchase all
Materials, including but not limited to those set forth in the
Packaging Specifications, required to complete the Secondary
Production of the Product. Cardinal Health shall provide MedImmune
with any inventory of all stored Materials and Product on a regular
schedule, and shall develop computer systems to enable MedImmune to
track and monitor inventories, all as required by MedImmune.
Detailed inventory transaction reports will be provided to
MedImmune by Cardinal Health on a schedule to be agreed upon by the
parties. In the event MedImmune desires to obtain the Materials
(other than the cartons, inserts or lids) from sources other than
Cardinal Health, it shall have the right to do so, at its own
expense, provided MedImmune notifies Cardinal Health at least
ninety (90) days in advance. In the event MedImmune is able to
obtain cartons, inserts or lids (in accordance with the Packaging
Specifications) at a cost less than the prices then in effect from
Cardinal Health, MedImmune shall notify Cardinal Health and
Cardinal Health shall have an opportunity to agree to match such
lower prices. In the event Cardinal Health does not agree to such
lower prices, MedImmune shall be permitted to obtain such Materials
from sources other than Cardinal Health, provided MedImmune
notifies Cardinal Health at least ninety (90) days in advance.
In the event MedImmune purchases such Materials itself, the price
for Product shall be adjusted as set forth in
Section 13.
6.5.
Labels and Secondary Production
.
(a) Thirty
(30) days prior to the intended date of commencement of
commercial production, MedImmune shall provide Cardinal Health
with: (i) any particular Packaging Specifications it may
have
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with respect to labels and
packaging materials and (ii) camera-ready artwork for
reproduction on labels, package inserts and packaging materials.
Such information shall include, but need not be limited to, the
quality, weight and color of the packaging materials and labels,
the type and colors of ink to be used in printing for the labels or
packaging materials and any special requirements for the labels or
packaging for the Product to be delivered to specific countries.
The method to assign lot numbers will be set forth in the Packaging
Specifications.
(b) Cardinal
Health shall reproduce the artwork on the labels, packages inserts
and packaging materials and imprint the appropriate lot number on
each individual unit and each carton of Product in accordance with
the designated lot numbers. Cardinal Health shall conduct all
Secondary Production in accordance with the Packaging
Specifications.
(c) In
the event that MedImmune desires to change any label, packaging
insert or packaging Material for all or any portion of the Product,
MedImmune shall supply Cardinal Health with new camera-ready
artwork and work with Cardinal Health to promptly coordinate the
use of such new artwork into Secondary Production process. In such
event, MedImmune shall purchase from Cardinal Health, at a price
equal to Cardinal Health's cost, all Materials in Cardinal Health's
inventory made obsolete by such changes.
6.6.
Secondary Production of Product
.
(a) Cardinal
Health shall conduct Secondary Production in accordance with the
Packaging Specifications and applicable federal, state and local
laws and regulations including, without limitation, cGMP. Cardinal
Health shall notify MedImmune of any difficulty in meeting
Packaging Specifications or any deviation therefrom immediately
upon discovery of such difficulty. Cardinal Health shall not
conduct Secondary Production nor Store Stored Materials or Product
at any other location other than the MedImmune Facility without the
prior written approval of MedImmune, and shall keep all Product
within the Secondary Area. Before, during and after Secondary
Production of each batch of Product, Cardinal Health shall monitor
the Secondary Production and Storage environments (other than the
freezers) and keep such records as all of the foregoing are
required by the Packaging Specifications and cGMP. Each Party shall
promptly notify the other of any new instructions or specifications
required by the FDA or the United States Federal Food, Drug and
Cosmetic Act, and of other applicable rules and regulations, and
shall confer with each other with respect to the best means to
comply with such requirements and shall allocate any costs of
implementing such changes on an equitable basis.
(b) The
Parties agree that it is their intention to identify ways in which
to enhance efficiencies in the Secondary Production and so reduce
production costs (" C ost Reduction Measures "). In
the event Cardinal Health expends amounts in undertaking Cost
Reduction Measures, including, for example, the purchasing of
additional production equipment and provided such costs are agreed
upon in advance by the parties in writing, MedImmune shall
reimburse Cardinal Health for such amounts. Any additional
equipment paid for by MedImmune under this Section 6.6(b)
shall be deemed MedImmune Production Equipment.
6.7.
Product Specifications; Testing
.
(a) Certain
of the Packaging Specifications are appended to this Agreement as
Appendix 2 . The Parties acknowledge that those
Packaging Specifications set forth in Appendix 2 which
are specific to the Secondary Production under this Agreement,
namely those procedures 211.MedImmune.1 through 211.MedImmune.12
and V0008 and V0014, may need to be refined and modified as the
Parties gain experience with Secondary Production, testing and use
of Product. Accordingly, the Parties agree to negotiate in good
faith to modify those MedImmune specific procedures from
time to time as the Parties' experience with Secondary Production,
testing and use of Product warrant; and Cardinal Health further
agrees that it will facilitate changes to Appendix 2
that are necessary or appropriate in light of FDA or
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other regulatory requirements.
The Parties agree to allocate on an equitable basis any special
costs of developing and implementing revised procedures.
(b) Product
supplied hereunder will conform to the Packaging Specifications,
and such conformance will be verified in accordance with the
testing standards and procedures specified therein. Cardinal Health
will forward a sample of each batch of Product to MedImmune for
testing and will supply MedImmune with a certificate of release ("
Certificate of Release ") confirming that such
Product produced meets the Packaging Specifications.
(c) The
Parties agree to work together in good faith to develop more
efficient packaging and testing procedures.
6.8.
FDA and Regulatory Support
.
(a) Cardinal
Health agrees to provide MedImmune with letters of access to any
files and documents required by the FDA or regarding Secondary
Production. MedImmune shall have sole responsibility for obtaining
from any Agency all permits and/or licenses necessary or required
for the sale, marketing or commercialization of Product. MedImmune
shall be responsible for all other filings necessary for approval
and import of Product into countries outside the United States.
Cardinal Health further agrees to use reasonable commercial efforts
to assist MedImmune in obtaining any government or Agency approval
that may be required for the marketing of Product in any country.
MedImmune shall provide Cardinal Health with written notice of any
additional regulatory requirements of countries other than the
United States that relate to Secondary Production. Cardinal Health
shall use its reasonable commercial efforts to comply
with
