Plasma Supply Agreement - DCI Management Group Inc. and MedImmune Inc.
PLASMA SUPPLY AGREEMENT
This Plasma Supply Agreement, dated effective as of the
6th day of February, 1996 by and between DCI Management
Group,Inc., a New Mexico Corporation, c/o G.W. Matlin, 71 South
Bedford Road, Mount Kisco, New York, ("Supplier") and
Medimmune, Inc., a Delaware corporation with offices at 35
West Watkins Mill Road, Gaithersburg, Maryland 20878
("Purchaser").
WITNESSETH:
WHEREAS, Purchaser desires to purchase Source Plasma (as
defined by Title 21 CFR 600.01 et seq) from Supplier in
connection with a program requiring plasma with acceptable
neutralizing titers for respiratory syncytial virus (RSV)
(hereafter termed "Product"); and
WHEREAS, Supplier is willing to supply Purchaser's
requirements for Product, up to specified levels;
NOW THEREFORE, in consideration of the premises and of
the mutual covenants and agreements herein set forth, the
parties hereto agree as follows:
1.0 TERM AND RENEWAL
1.1 The initial term (the "Initial Term") of this
Agreement shall begin on the effective date noted above and
unless sooner terminated as provided herein shall continue
for a period of three (3) years from the date of this
Agreement. In anticipation of the parties extending this
Agreement beyond the Initial Term, the parties agree that
during the month of November, 1996 and annually thereafter
they shall meet for the purpose of negotiating volumes and
prices for the 12-month period three years into the future.
For example in November, 1996 the parties shall meet to
discuss volumes and prices for months 37-48.
2.0 PRODUCTS AND PRICES
2.1 Supplier shall supply to Purchaser for the Initial
Term, and any extension thereof, Product in accordance with
the specifications attached as Exhibit A hereto (hereafter
the "Specifications") .
2.2 During the first twelve months of this agreement,
Purchaser shall pay for Product purchased hereunder at a
price equal to (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) per
liter of plasma, F.O.B. Louisville, KY or Aberdeen, MD, or any
destination in continental U.S. as directed by Purchaser. The
price for months 13-24 will be reviewed on or before November 1,
1996, and on or before November 1, 1997 for months 25-36 of the
contract. Based on existing plasma market prices for all
source plasma types in the domestic and international market
places there shall be a price increase each year. The minimum
increase of the price hereunder for each 12 month period
shall be the percentage change in the Consumer Price Index
(All Urban Consumers CPI-U/United States City Average/All
Items Indexed) over the previous twelve month period as
determined and published by the United States Department of
Labor/Bureau of Labor Statistics and the maximum shall be
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED). In no event shall
the price ever be less than the initial price hereunder. The
parties shall negotiate such price increase in good faith. If the
parties cannot agree by December 15th on a new price, each party
shall select a proposed price within the above parameters for
submission to an arbitrator who shall select one party's
proposal. The arbitrator shall be selected by the parties, and
the arbitration shall be conducted, according to the rules of the
American Arbitration Association, and the arbitrator's decision
shall be final and non-appealable. Each party shall pay its own
costs and expenses, including attorneys fees and costs incurred
in any proceedings in court to confirm the arbitration decision.
Pending the decision of the arbitrator, Purchaser shall pay one-
half of Supplier's proposed price increase per liter for each
liter of plasma purchased during the year and upon determination
by the arbitrator of the applicable price for such year the
parties shall promptly adjust their accounts retroactively,
including interest on the amount owed at the prime rate as
published daily in the Wall Street Journal (the "Prime Rate").
The actual price paid by Supplier for any tests required or
recommended by the US FDA or adopted by the Plasma Industry which
are not set forth in Section 5.2 shall be added to the agreed
upon price and shall not be considered as part of the price
increase for purposes of this Section. Such additional test costs
which may occur during any period where the price has already
been established shall automatically be added to the price per
liter effective on test implementation date. Supplier shall use
its best efforts to keep such cost to a minimum.
3.0 PAYMENT
3.1 Purchaser shall pay for Product at the price set
forth in Section 2.2 Terms of payment are net thirty (30)
days from date of shipment.
3.2 The price set forth in Section 2.2 includes
manufacturing, packaging, quality control and holding of
Product and does include the cost of shipment to the F.O.B.
point.
3.3 Each invoice will include the following details:
a) shipment number
b) cost per shipment
c) volume per shipment
d) bill of lading number of each shipment
e) center name
f) number of cartons
g) carton sequence
h) cost per liter
i) total volume
j) total cost for the invoice
4.0 ORDER AND DELIVERY
4.1 Supplier shall provide Purchaser (through
Purchaser's designee laboratory) at no cost to Purchaser
plasma samples in amounts and at times mutually agreed upon
by Purchaser and Supplier. In the event that a Plasmapheresis
center is supplying plasma for two (2) of the Purchaser's
plasma programs, the Supplier shall, as directed by the
Purchaser provide two (2) separate plasma samples, one for
each program to the same or different locations as designated
by Purchaser. These samples shall enable Purchaser to test
and identify plasma donors and/or plasma lots suitable for
producing Product for Purchaser in accordance with the
Specifications.
4.2 All sales of Product by Supplier to Purchaser
hereunder shall be subject to the provisions of this
Agreement and shall not be subject to the terms and
conditions contained in any purchase order of Purchaser or
confirmation of Supplier except insofar as any such purchase
order or confirmation establishes Product ordered or sold
thereunder and the delivery date and carrier thereof.
4.3 During the initial 24-month term of this Agreement
Purchaser shall accept all material from identified
acceptable RSV donors up to the following maximum volumes:
for the period covering months 1 thru 12 -(CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED); for the period covering months 13 thru 24 -
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)and for the period
covering months 25 thru 36- (CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED). Notwithstanding the aforesaid, after the initial 24
month period if Purchaser determines that its total annual
volume needs of RSV plasma is less than the amount then
currently being supplied by Supplier, Purchaser shall notify
Supplier in writing of its anticipated total volume
requirement from all vendors for months 25-36 of the Initial
Term of the Agreement and in such event Supplier shall cease
sending new donor samples for screening to Purchaser's
laboratory in order to limit growth in RSV plasma production.
Purchaser however, shall continue to purchase all material
produced from previously approved donors for the period
covering months 25 thru 36 up to a maximum of(CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED). If at any time during the 25th -
36th months the average volume of plasma produced from previously
approved donors drops below (CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED)of the needed total volume of material required by
Purchaser from all Suppliers, then in such event Supplier shall
resume sending samples of new donors plasma to Purchaser's
laboratory for testing and approval, and Purchaser shall accept
such RSV plasma from Supplier up to a level equal to
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) of Purchaser's total
RSV annual volume requirements.If at any time during the initial
36-month period of thiscontract or any extension period Purchaser
is unable toproduce finished product from the RSV plasma being
suppliedas a result of U.S. Food and Drug Administration
suspension or revocation of Purchaser's license or Purchaser's
voluntary withdrawal of all finished product from the market
place,then in such event Purchaser may elect to suspend this
Agreement until such time as the production and sale of
finished product is reinstated provided Purchaser accepts and
timely pays for all RSV plasma from approved donors which
was drawn from donors prior to the date of the Food and Drug
Administration's suspension or revocation of Purchaser's
license or Purchaser's voluntary withdrawal of all finished
product from the market place. This paragraph shall not be
interpreted as in any way being in conflict with Section 16.0
of this Agreement.
4.4 Supplier shall arrange insured common carrier
transportation of Product to Purchaser's designated
destination. Such carrier shall be a qualified shipper of
perishable medical products and shall be approved in advance
by both Purchaser and Supplier. Title to and risk of loss of
Product shall pass to Purchaser at the time of delivery to
the carrier at the F.O.B. point. Supplier shall use its best
efforts to deliver quantities of the Product specified
herein, it being understood that Purchaser shall accept
Supplier's total RSV production from acceptable approved
donors during the initial period of this contract up to the
maximum herein before set forth sub section 4.3. Supplier's
failure to supply quantities of RSV plasma equal to
Purchaser's production needs or maximum volumes herein before
set forth shall not be deemed a breach of contract, it being
understood and agreed that the Supplier has no control over
the volume of RSV plasma to be collected at various
facilities. Supplier shall invoice Purchaser for Product no
earlier than the date of shipment.
4.5 Supplier shall schedule the timely shipment of
Product pursuant to Purchaser's requirements as established
by Purchaser in writing. For the purpose of this Agreement, a
timely shipment shall be a shipment that leaves the F.O.B.
point not later than two weeks after approval from Purchaser
to ship product. No shipment, however, shall be for less than
40 liters of material. It is also agreed that Supplier can
ship prior to receipt of shipping authorization from
Purchaser's designee laboratory; conditioned upon the
following:
A - Purchaser pays for material when units are
authorized. Supplier can bill without authorization if
authorization has not been received three (3) weeks from date
of shipment of samples.
B - Supplier will issue a credit memo to Purchaser for
any unauthorized units that are shipped in error.
4.6 Supplier shall supply Purchaser a list of all
centers covered by this Agreement. (Exhibit B) Supplier shall
have the right to add additional centers to said list with
prior written approval of Purchaser, so long as Purchaser is
not then currently purchasing plasma from said additional
centers.
5.0 QUALITY CONTROL
5.1 Supplier and its subcontractors and vendors shall
manufacture Product in accordance with the Specifications.
All plasma collection facilities shall be currently QPP
certified by the American Blood Resources Association.
5.2 Plasma shipments will be accompanied by a plasma
packing list that records for each unit shipped a unit
number, donor identification number, draw date, volume and
test results for HBsAg, ALT, Anti HIV I & II and Anti HCV. A
six-month "look back" program on Donors reactive to HBsAg and
Anti HIV I & II will remain in effect on all units shipped to
Purchaser. The tests used for screening plasma shipped to
Purchaser shall conform to the most current technology
available for use in the plasma collection industry and shall
conform to FDA requirements for such tests.
5.3 Supplier agrees that all Product supplied hereunder
and the manufacture and delivery thereof shall be in
compliance with all applicable laws and regulations (21 CFR
211.606 and 640).
5.4 Supplier shall provide Purchaser's Quality Control
Department with a reasonable number of production samples of
Product for QC testing by Purchaser.
5.5 All product manufactured and sold hereunder is
subject to Purchaser's inspection, prior to acceptance
pursuant to Section 6.1.
5.6 Purchaser shall have the right upon reasonable
advance notice during normal business hours to inspect each
facility at which Product is produced for the purpose of
observing production and quality control and inspecting all
documents applicable to manufacture, processing and holding
of Product. Such inspections shall be limited to a frequency
of no more than once every 12 months unless quality deviations
occur, in which case Purchaser shall have the right to
inspect more often. All source documents concerning
laboratory testing shall be retained in accordance with FDA
regulations and they shall be available for inspection by
Purchaser.
5.7 Purchaser and Supplier shall immediately notify
each other with respect to any "Look Back" and adverse Drug
Reaction Reports with respect to Acceptable Donors and
resulting Product.
6.0 ACCEPTANCE AND REJECTION
6.1 If upon receipt and inspection of Product by
Purchaser at the destination specified in the shipping
instructions, the shipment, or any portion thereof, does not
conform to the order or the Specifications, Purchaser shall
promptly notify Supplier of such condition and afford
Supplier a reasonable opportunity to inspect the Product and
make any appropriate adjustment or replacement. Supplier
shall complete the adjustment or replacement within sixty
(60) days of notification by Purchaser. The cost of any
replacement shall be at the sole expense of Supplier
including any return shipment or reshipment. During this
period and at all times prior to shipment by Supplier, plasma
is to remain stored at temperatures specified by FDA
regulations.
6.2 In the event Purchaser experiences an over supply
of Product resulting in excess inventory, upon reasonable
written request by Purchaser, Supplier shall use its best
efforts to assist Purchaser in selling such excess Product
through Supplier's existing distribution channels.
7.0 COLLECTION SITES
7.1 Supplier and Purchaser will determine by mutual
agreement the plasmapheresis locations which will provide
samples and/or plasma for the program herein mentioned.
Centers chosen will remain in the program until all Donors
from a center are removed from the program due to antibody
titer loss or the program comes to an end. Before admittance
to the program all centers must provide to the Purchaser a
completed Plasmapheresis Center Information Form, as supplied
by the Purchaser or Purchaser's designee laboratory. It is
agreed that no proprietary questions will be answered by
Supplier. In addition, it is agreed that a general company
overview can be utilized to answer questions that have the
same answers for all centers. It is understood and agreed
that the identification of donors by Purchaser as meeting
Purchaser's specification for production of RSV Hyperimmune
Globulin is proprietary information and that although
Supplier does not know Purchaser's exact specifications
Supplier is aware that once a donor has been identified as
meeting such specifications, such plasma could potentially be
sold to third parties for manufacture by such third parties
into RSV Hyperimmune Globulin. Accordingly, it is agreed that
supplier will not, during the term of this agreement and for
twelve months thereafter, knowingly sell plasma from any
approved donor identified by Purchaser as having RSV Antibody
to any other purchaser for the intended use by such other
purchaser in the manufacturing of RSV Hyperimmune Globulin.
8.0 TERMINATION
8.1 In addition to any other remedy it may have, either
party shall have the right to terminate this Agreement if the
other party fails to remedy and make good any material
default in the performance of any material condition or
obligation under this Agreement within sixty (60) days of
written notice thereof.
8.2 The failure of either party to terminate this
Agreement by reason of the breach of any of its provisions by
other party shall not be construed as a waiver of the rights
or remedies available for any subsequent breach of the terms
or provisions of this Agreement.
8.3 The exercise of one remedy by a party shall not
preclude such party from exercising additional remedies.
8.4 Upon termination of this Agreement, Purchaser must
pay for any Product already delivered.
8.5 Either party may terminate this Agreement effective
immediately upon giving notice of termination, if the other
party shall file a petition in bankruptcy, shall be
adjudicated as bankrupt, shall take advantage of the
insolvency laws of any state, territory or country, shall
make an assignment for the benefits of creditors, shall be
voluntarily dissolved, or shall have a receiver, trustee or
other court officer appointed for its property.
8.6 Purchaser further covenants and agrees that during
the term of this Agreement and any renewal or extension
period and for twelve (12) months thereafter, Purchaser shall
not, without the express written consent of Supplier
purchase any plasma of the same or similar specifications as
set forth in Exhibit "A" directly or indirectly from any
parties who have supplied such plasma to Supplier and which
Supplier sold to Purchaser. It is agreed and understood that
any breach by Purchaser of this covenant set forth in this
sub paragraph 8.6 shall cause irreparable harm to Supplier
and Supplier shall be entitled to obtain an injunction
against Purchaser in addition to any other legal or equitable
remedies available to Supplier.
9.0 WARRANTIES AND INDEMNIFICATIONS
9.1 Supplier warrants and represents that at the time
of shipment, Product covered by this Agreement shall conform
to the applicable Specifications and the other requirements
expressly set forth in this Agreement and that the Supplier
shall deliver Product to Purchaser free from claims or liens
of third parties that may affect title to the Product.
9.2 Purchaser shall indemnify and hold Supplier
harmless from any and all third party claims of disease
related liability arising from the use in manufacturing of
Product provided by Supplier, except those which result from
Supplier's negligence or willful misconduct. Supplier shall
promptly notify Purchaser of any such claims. Where Purchaser
acknowledges that the indemnification is applicable with
respect to such claims Purchaser shall control the defense,
settlement or compromise of any such claims.
10.0 NOTICES
10.1 Any and all notices permitted or required to be
given hereunder shall be sent by registered or certified
mail, postage and fees paid, with return receipts requested,
addressed as on the first page of this Agreement or at such
other address as to which a party gives notice under this
Section 10.1. Notice shall be deemed given as of the date of
mailing.
11.0 ASSIGNMENT
11.1 Neither party shall assign this Agreement in whole
or in part other than as part of the sale of all or
substantially all of its business assets without the prior
written consent of the other. Upon a permitted assignment,
all of the provisions of this Agreement and all rights and
obligations of the parties hereunder shall be binding upon
and inure to the benefit and be enforceable by the successors
and assigns of Supplier and Purchaser.
12.0 ENTIRE AGREEMENT
12.1 This Agreement, including the Exhibits attached
hereto constitutes the sole and entire Agreement between the
parties with respect to the sale of Product by Supplier to
Purchaser and may not be altered or modified except in
writing and signed by duly authorized officers of both
parties.
13.0 INDEPENDENT CONTRACTOR
13.1 In all activities under this Agreement, Supplier
shall act and be deemed an independent contractor with no
authorization to in any way obligate or bind Purchaser. This
Agreement shall not be deemed held or construed as creating a
copartnership between Supplier and Purchaser for any purpose
whatsoever.
14.0 SEVERABILITY
14.1 If any terms or provisions of this Agreement shall
be invalid or unenforceable, the remaining terms hereof shall
not be affected, but shall be valid and enforced to the
fullest extent permitted by law, unless such invalid or
unenforceable term or provision materially affects a party's
rights or expected rights under this Agreement.
15.0 HEADINGS
15.1 The headings used in this Agreement are intended
for guidance only and shall not be considered part of the
written understanding between the parties hereto.
16.0 FORCE MAJEURE
16.1 Neither party shall be liable for non-performance
caused by factors beyond that party's direct control, said
factors including but not being limited to:
(i) natural disasters or other "Acts of God";
(ii) riots, wars, or insurrection; or
(iii) actions of any governmental agency, including
rules, laws, orders, regulations and
restrictions.
17.0 APPLICABLE LAW
17.1 This Agreement shall be construed and enforced in
accordance with the law of the State of New York without
reference to choice of law principles.
IN WITNESS WHEREOF, the parties have caused this
Agreement to be executed by their duly authorized officers
as of the day and year first above written.
MEDIMMUNE, INC. DCI MANAGEMENT GROUP, INC.
BY: David M. Mott BY: Ira London
President Secretary
2/7//96 2/7/96
EXHIBIT A
SPECIFICATIONS FOR RSV SOURCE PLASMA
1. PURCHASER'S DESIGNEE
Plasma samples and plasma units are to be shipped for
screening and processing to such persons or entities
designated by Purchaser from time to time. Purchaser's
designee for receipt of plasma samples shall be the
Massachusetts Public Health Biologics Laboratory
(MPHBL). Purchaser shall notify Supplier in writing of
any change in such designee.
2. LICENSES
Supplier shall supply Medimmune and its designee with
documentation that each Source Plasma center of Supplier
selected by Supplier for producing Product is currently
licensed by the FDA for collection of Source Plasma
(i.e. copy of FDA license).
3. PLASMA SAMPLES
A 0.5 ml sample of plasma from each donation from donors
for whom Supplier seeks qualifications must be submitted
and received by Medimmune or its designee.
4. ACCEPTABLE RSV DONORS
Medimmune or its designee will advise Supplier of donor
acceptable for contributing to the RSV plasma supply
program ("Acceptable Donors") based on the donor's RSV
antibody titers. Acceptable Donors must also meet the
FDA requirements for Source Plasma. Acceptable Donors
will continue to remain acceptable based on their RSV
titers until Medimmune or its designee notifies Supplier
in writing that the donor is no longer acceptable.
Acceptable Donors shall be removed from the RSV program
immediately upon receiving such notification from
Medimmune or its designee. Plasma from Acceptable Donors
drawn up to the day after notification date will be
accepted.
5. ACCEPTABLE RSV PLASMA UNITS
All plasma drawn from Acceptable Donors (see item #4
above) will be accepted as long as the Donor remains an
Acceptable Donor and the plasma meets all FDA
requirements for Source Plasma. If a Donor becomes
unacceptable, all plasma units collected up to the day
after notification will be accepted but units drawn
after that date will not be accepted (see item #4
above). Before shipping plasma units, Supplier must send
a copy of the proposed "Plasma Packing List" (see item
#6 below) to Medimmune or its designee for verification.
6. LABELLING AND TESTING
Plasma shipments must be accompanied by a "Plasma
Packing List" that records for each unit shipped in
identification (i.e. "Control") number of the unit, a
donor identification number, signature of pheresis
center Manager, date plasma was drawn, volume and
results of the HBsAg, Anti HIV I & II and Anti HCV, and
ALT tests.
7. "LOOK BACK"
Purchaser must be informed of any donor becoming
positive for Anti HIV I & II or HBsAg, if plasma from
that donor has been shipped to Purchaser anytime during
the preceding 6 months, so the Purchaser can judge if
previous donations are acceptable for fractionation.
8. DELIVERY AND SHIPPING
A. Until Supplier is notified otherwise as
contemplated in item #1 above, plasma should be
shipped to:
Baxter Hyland Protein Control
4501 Colorado Blvd.
Los Angeles, CA 90039
B. Invoice should be sent to:
Medimmune, Inc.
35 West Watkins Mill Road
Gaithersburg, MD 20878
C. Plasma should be shipped frozen in suitable
containers so that the plasma is maintained at
temperatures specified by FDA regulations or
required for product integrity. The requirement for
product integrity of RSV is minus 20 degrees
Celsius.
D. Plasma is to be shipped in containers with
cardboard dividers. Each case will have a barcode
affixed on the outside of the carton. The exact
details of information on barcode will be mutually
agreed to.
E. DCI will provide Medimmune a copy of Bill of Lading
and Packing List for each unit within 48-hours of
shipment.
F. DCI will have management reports for Medimmune to
review material expected, material received,
material processed, and material cleared for
shipment. It is agreed that DCI and MedImmune's MIS
staff will review the best format for reports. DCI
and MedImmune will review the ability for MedImmune
to have access to certain data on the RSV computer
system. At a minimum the information required would
include, but not be limited to, the following data
which might be accessed either weekly, monthly or
quarterly: number of screens sent, number of donors
enrolled, number of units authorized, number of
units picked up/sent (broken down by shipment and
volume), number of new donors enrolled, number of
screens sent to enroll those donors, number of
donors dropped from the program, enrollment dates,
number of units sent since enrollment, date dropped
from the program, and number of units sent weekly,
monthly and/or quarterly. Data will be provided on
any kind of ASCii file, preferably, delimited, with
a standard output that is on PC accessible media.
It is agreed that all donor information is
confidential in addition, it is agreed that all
software design, including Data Base structures and
other proprietary information be confidential to
the extent that such information is not already in
Purchaser's possession or is not now hereafter
entered in the public domain, such information is
supplied only for Purchaser's internal use. At no
time can it be discussed with any Third Party
without prior written approval of Supplier.
9. The following are the procedures to cover all RSV
Plasma collected from approved donors.
A. DCI will send RSV confirm samples and paperwork for
complete cartons only. The samples will be sent
with an electronic packing form disk.
B. The cover sheet will be modified (example attached)
to indicate the number of cartons, individual
carton numbers, and total units from each
individual center.
C. Mass Laboratory will inspect each incoming sample
shipment and advise if the shipment was complete or
which units are missing sample tubes. There will be
a place on the coversheet for Mass Lab to confirm
the number of samples received from each center. If a
sample is missing, Mass will indicate in the space
provided, the details indicating which bleed is
missing a sample. It is understood that Mass has
agreed that it will confirm within three days from
receipt of the samples.
D. DCI will give its best effort to obtain the missing
sample and send it with the following weeks
confirmed samples package. It is agreed that the
packing list for the entire carton will be sent
with the sample. Mass has agreed to give their best
effort to release single unit shipments at the same
time as the entire lot.
E. Mass will advise DCI of any problem units within
any individual carton. DCI will arrange for the
corrected paperwork for the individual carton
involved to be faxed to Mass.
F. Within a two week period, it is Purchaser's and
Supplier's understanding Mass will issue to DCI
confirmation shipment verification. The
verification will reflect the details of the
original paperwork or the paperwork with any
changes that were required by Mass prior to
verification. We expect Mass to issue confirmation
by entire lots, same as they receive them,
confirmation including lot numbers.
G. DCI Centers will ship to Bio Med when confirmation
shipment verification is received. All paperwork
will be modified if required to remove any problem
units. The paperwork will be sent with shipping
disk the same as always. A copy of the Bill of
Lading will be included with paperwork.
H. All Nabi and contract centers will send in modified
paperwork to reflect any changes required by Mass
prior to receipt of verification. Upon verification
notice, DCI will submit corrected paperwork and
shipping disk to Mass. The actual shipment will not
leave the Queens Village warehouse until shipping
approval is received. It is Purchaser's and
Supplier's understanding that Mass will issue
shipping approval within a two week period after
date of shipment of samples to Mass. DCI may ship
and bill MedImmune if approval is not received
within the time period defined in section 4.5A of
the RSV Agreement.
EXHIBIT B
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)