EXHIBIT 10.195


 


Certain confidential information contained in
this document, bracketed in the text and marked as confidential, 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.


 


MASTER AMENDMENT AGREEMENT


 


This Master Amendment Agreement (the “Master
Amendment”), is entered into as of September 30, 2003 (the “Master Amendment Effective Date”), by and
between MedImmune Vaccines, Inc. (formerly
Aviron), a Delaware corporation (“MedImmune”),
and Wyeth  (formerly
known as American Home Products Corporation), a Delaware corporation acting
through its Wyeth Pharmaceuticals division (“Wyeth”).


 


Recitals:


 


A.                                    Wyeth and the predecessor-in-interest of
MedImmune entered into that certain United States License and Co-Promotion
Agreement dated as of January 11, 1999, as amended October 23, 2002
(the “U.S. Agreement”), regarding
the development, manufacture (to the extent set forth in the Supply Agreement
(as defined below)), distribution, use, marketing and co-promotion of
MedImmune’s proprietary intranasally delivered cold-adapted vaccine formulation
against influenza and influenza-associated illnesses, including otitis media
infection, known as FluMistTM or FluEnzTM (collectively, “FluMist”), in the United States and its
territories and possessions.


 


B.                                    Wyeth also has the right, pursuant to that
certain International FluMistTM License Agreement, dated as  of January 11, 1999 (the “International Agreement”), by and between
Wyeth and the predecessor-in-interest of MedImmune, to exclusively develop,
manufacture (to the extent set forth in the Supply Agreement), distribute, use,
market and sell FluMist in certain territories outside of the United States and
its territories and possessions.


 


C.                                    That certain FluMistTM Supply
Agreement between Wyeth and the predecessor-in-interest of MedImmune dated
January 11, 1999, as amended January 1, 2001 and October 23,
2002 (the “Supply Agreement”),
provides for the manufacture and supply of the Frozen Product and the Liquid
Product (as such terms are defined in the Supply Agreement) for distribution
and sale by Wyeth under the terms and conditions of the U.S. Agreement and
International Agreement.


 


D.                                    The parties desire to amend the U.S. Agreement,
the International Agreement, the Supply Agreement and the related letter
agreement executed by the parties as of October 23, 2002 (the “Letter Agreement,” and all such agreements
collectively, the “Agreements”) to
clarify the understanding and intent of the Agreements and to amend the
Agreements as detailed below.


 


In consideration of the foregoing recitals and the mutual covenants and
agreements contained in this Master Amendment, the parties hereby agree as
follows:


 


Agreement:


 


1.                                      Definitions.  All defined
terms used and not otherwise defined in this Master Amendment have the meanings
ascribed to such terms in the Agreements. 
Provisions of this Master Amendment that reference terms that are
defined in more than one Agreement will be deemed to be applicable to the
particular Agreement or Agreements that the provision amends.


 


2.                                      Forecasts; Pricing and
Payment for MedImmune-Manufactured Product.  This Section 2
supercedes conflicting provisions of each of the Agreements.  Without limiting the scope of the preceding
sentence, Sections 7.1, 7.2 and 7.3 of the Supply Agreement (set forth in the
Second


 


1

















 


Amendment of the Supply Agreement) are hereby deleted (except for
Sections 7.2(b) and 7.3(b) which will survive with the amendments set forth in
the next sentence) and superceded by this Section 2.  As conforming changes,


 


(a)                                  the term “Late Doses” as used in the Supply
Agreement will continue to be defined as “doses of MedImmune-Manufactured
Product delivered to Wyeth later than the month in which such doses are to be
delivered under the applicable Forecast for the applicable Flu Season;


 


(b)                                 the third sentence of Section 7.2(b) of
the Supply Agreement is superceded as follows: 
“With respect to any Late Doses during the applicable Flu Season, the
amount due to MedImmune with respect to those doses in the interim and final
reconciliation calculations for that Flu Season (as set forth in Section 2.3(c)
of the Master Amendment) will be equal to (CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED) of the Net Sales attributable to the Late Doses sold and not
subsequently returned in that Flu Season.”


 


(c)                                  the third sentence of Section 7.3(b) of
the Supply Agreement is superceded as follows: 
“With respect to any Late Doses during the applicable Flu Season, the
amount due to MedImmune with respect to those doses in the interim and final
reconciliation calculations for that Flu Season (as set forth in Section 2.4(c)
of the Master Amendment) will be equal to (CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED) Of the Net Sales attributable to the Late Doses sold and not
subsequently returned in that Flu Season.”; and


 


(d)                                 the first sentence of Section 7.5 of the
Supply Agreement is superceded as follows: 
“MedImmune shall have the right to audit Wyeth’s records in order to
confirm its calculation of the payments owed to MedImmune under the Agreements,
as amended by this Master Amendment.”


 


For
clarity, Sections 7.2(b) (as modified by clause (b) of the preceding sentence),
7.3(b) (as modified by clause (c) of the preceding sentence), 7.4 and 7.5 (as
modified by clause (d) of the preceding sentence) of the Supply Agreement will
remain in full force and effect.  For
clarity, the terms “MedImmune Vaccines-Manufactured Product” and “MedImmune-Manufactured
Product” are to be used interchangeably and have the meaning ascribed to the
term “MedImmune Vaccines-Manufactured Product” in the Supply Agreement.  The parties agree that this Section 2
describes only those payments due to MedImmune with respect to the delivery to
and acceptance by Wyeth of MedImmune Manufactured Product.  This Master Amendment is in no way meant to
alter, amend or otherwise modify any royalty or milestone payment due to MedImmune
under the Agreements, except to the extent set forth in Sections 4.1 and
4.3(b).


 


2.1                               Certain Definitions; Rules
of Construction.


 


(a)                                  Doses Sold, Returned or
Unsold.  For the purposes of this Section 2,
doses “sold” by Wyeth will mean doses of Product accepted by Wyeth and sold by
Wyeth to a Third Party whether or not those doses are subsequently
returned.  Doses sold that are
“subsequently returned” or doses “returned” will mean doses of Product that are
accepted by Wyeth and initially sold by Wyeth to a Third Party but then are
later returned (in accordance with Wyeth’s returned goods policy applicable to
the Product) and are not resold during the applicable Flu Season.  “Unsold” doses are doses of Product that are
accepted by Wyeth but not sold to a Third Party.  “Accepted” doses are those doses of MedImmune-Manufactured
Product delivered to Wyeth by MedImmune and accepted by Wyeth in accordance
with Section 6.3 of the Supply Agreement.


 


(b)                                  Determinations of
MedImmune-Manufactured Product.  To the extent any Product is not
manufactured by MedImmune and therefore one or more of the calculations in


 


2

















 


this Section 2 require determining the amount of
MedImmune-Manufactured Product sold, returned or unsold, such amount will be
determined by multiplying the number of doses of Product sold, returned or
unsold, as applicable, by the ratio of (1) MedImmune-Manufactured Product
accepted by Wyeth divided by (2) the sum of (A) Product (other than
MedImmune-Manufactured Product) produced for the applicable Flu Season and
released for distribution plus (B) doses of MedImmune-Manufactured
Product accepted by Wyeth (such ratio, the “MedImmune-Manufactured
Product Ratio”).


 


(c)                                  Determinations of Net Sales
Attributable to MedImmune-Manufactured Product.  To
the extent any Product is not manufactured by MedImmune and therefore one or
more of the calculations in this Section 2 require determining the
amount of Net Sales attributable to MedImmune-Manufactured Product, such amount
will be determined by multiplying Net Sales for the applicable Flu Season by
the MedImmune-Manufactured Product Ratio. 
The parties agree that for the purposes of this Section 2,
Net Sales will include only those Product sales in the Territory (as defined in
the U.S. Agreement).  If and when
MedImmune produces Finished Product under Section 18.8(a)(iii) of
the International Agreement and that Product is MedImmune-Manufactured Product,
then the parties agree that separate calculations under this Section 2
will be made for sales in the Territory (under the International Agreement) and
in such case Net Sales will include only those Product sales in the Territory
(as defined in the International Agreement).


 


2.2                               2003-2004 Flu Season.  The
parties agree that the JCC Forecast and the U.S. Frozen Forecast for the
2003-2004 Flu Season are both 4,100,000 doses. 
Because the JCC Forecast for the 2003-2004 Flu Season is in excess of
4,000,000 doses and Regulatory Approval for the Frozen Formulation in the
Territory was obtained before June 30, 2003, Wyeth agrees that MedImmune
has earned and Wyeth will pay the $12,500,000 milestone described in
Section 8.3(a)  of the U.S.
Agreement no later than December 31, 2003.


 


2.3                               Payments for First Four Flu
Seasons.


 


(a)                                  Generally.  The total
transfer amount due to MedImmune in respect of the MedImmune-Manufactured
Product accepted by Wyeth during any of the first four Flu Seasons will be the
transfer price for those doses as described in this Section 2.3.  Upon acceptance of each shipment of doses of
MedImmune-Manufactured Product for each of the first four Flu Seasons, Wyeth
will make an estimated transfer price payment to MedImmune in respect of such
doses.  No later than April 30 of
each Flu Season, Wyeth will provide MedImmune with a written description of the
interim aggregate actual transfer price due to MedImmune for that Flu Season  as of that date describing Wyeth sales of
the Product (i.e., indicating the
number of doses sold, the number doses returned and the number of unsold
doses), with a detailed description of the applicable reconciliation
calculation. If the reconciliation calculation indicates that any amount is
owed to MedImmune, Wyeth will pay MedImmune that amount within 30 days after
receiving the reconciliation calculation. 
If the reconciliation calculation indicates that any amount is owed to
Wyeth, MedImmune will pay Wyeth that amount within 30 days after receiving the
reconciliation calculation.  No later
than 30 days after the end of each Flu Season, but in any event by July 31
of the applicable Flu Season, Wyeth will provide MedImmune with a written
description of the final aggregate actual transfer price due to MedImmune for
that Flu Season  describing Wyeth
sales of the Product (i.e.,
indicating the number of doses sold, the number doses returned and the number
of unsold doses), and a detailed description of the applicable reconciliation
calculation.  If the reconciliation
calculation indicates any amount is owed to MedImmune, Wyeth will pay MedImmune
that amount within 30 days after receiving the reconciliation calculation. If
the reconciliation calculation indicates that any amount is owed to Wyeth,
MedImmune will pay Wyeth that amount within 30 days after receiving the
reconciliation calculation.  For the
purpose of this Section 2.3(a), the estimated transfer price
payment


 


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for each shipment will be calculated as set forth in Section 2.3(b),
and the aggregate actual transfer price and reconciliation for the applicable
Flu Season  will be calculated as
set forth in Section 2.3(c).


 


(b)                                  Estimated Transfer Price
Payment Calculations.  For the purpose of Section 2.3(a),
the estimated transfer price payment per shipment of doses accepted by Wyeth
will be calculated as follows:


 


TPe = Das  ́ Pe


 


where:


 


TPe is the estimated transfer price per shipment;


Das is the number of doses of MedImmune-Manufactured Product accepted by
Wyeth in the shipment; and


Pe is the estimated average transfer price per
dose, which is constant throughout any given Flu Season and calculated as
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) of (1) the estimated Net Sales
attributable to MedImmune-Manufactured Product for the Flu Season divided by
(2) the Forecast of MedImmune-Manufactured Product for that Flu Season less
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)of the estimated number of returned
doses of MedImmune-Manufactured Product for that Flu Season.


 


For
the purpose of determining the estimated average transfer price per dose (Pe) for a
particular Flu Season, Wyeth and MedImmune agree that Pe for the
2003-2004 Flu Season is (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED). For all
subsequent Flu Seasons, the JCC (or ICC, as applicable) will calculate and
provide the parties with the Pe for that Flu Season no later than 90 days
before the beginning of the applicable Flu Season.  For the purpose of this Section 2.3(b), the beginning
of the Flu Season in the case of the Northern Hemisphere will be deemed to be
September 1  and for all other
regions will be determined by mutual agreement of the parties.


 


(c)                                  Reconciliation; Aggregate
Actual Transfer Price Calculations.  For the purpose of Section 2.3(a),
the aggregate actual transfer price for the applicable Flu Season  will be calculated as follows:


 


TPa = Da  ́ Pa


 


where:


 


TPa is the aggregate actual transfer price for the applicable Flu Season (i.e., the total payment due to MedImmune);


Da is the total number of doses of MedImmune-Manufactured Product
accepted by Wyeth during the Flu Season; and


Pa is the actual average transfer price per
dose, which is calculated as (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) of (1)
the actual Net Sales attributable to MedImmune-Manufactured Product for the Flu
Season divided by (2) the total number of doses of
MedImmune-Manufactured Product sold by Wyeth during the Flu Season less
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) the number of doses of
MedImmune-Manufactured Product sold by Wyeth during the Flu Season and
subsequently returned.


 


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If the interim payment due to MedImmune under this Section 2.3(c)
for a Flu Season (i.e., TPa)
exceeds the estimated payment made to MedImmune under Section 2.3(b)
for that Flu Season (i.e., TPe) then
the amount due to MedImmune at the interim payment period will be TPa  minus TPe.  Conversely, if TPe exceeds TPa then the amount due to
Wyeth will be TPe  minus TPa.


 


If the final payment due to MedImmune under this Section 2.3(c)
for a Flu Season exceeds the estimated payment made to MedImmune under Section 2.3(b)
for that Flu Season (as adjusted to reflect any interim payment), then that
excess will be the amount due to MedImmune at the final payment date.  Conversely, if the estimated payment made to
MedImmune under Section 2.3(b) for that Flu Season (as adjusted to
reflect any interim payment) exceeds the final payment due to MedImmune under
this Section 2.3(c), then that excess will be the amount due to
Wyeth at the final payment date.


 


To the extent any amount is due to MedImmune in respect of Late Doses,
such amount will be added to TPa in the interim and reconciliation
calculations above.


 


2.4                               Payments for Fifth and
Subsequent Flu Seasons.


 


(a)                                  Generally.  The total
transfer amount due to MedImmune in respect of the MedImmune-Manufactured
Product accepted by Wyeth during any of the fifth and subsequent Flu Seasons
will be the transfer price described in this Section 2.4 plus
payments for unsold and returned doses (also described in this Section 2.4).  Upon acceptance of each shipment of doses of
MedImmune-Manufactured Product for each of the fifth and subsequent Flu
Seasons, Wyeth will make an estimated transfer payment (including an estimate
of the payments for unsold and returned doses) to MedImmune in respect of such
doses.  No later than April 30 of
each Flu Season, Wyeth will provide MedImmune with a written description of the
interim aggregate transfer payments due to MedImmune for that Flu Season  as of that date describing Wyeth sales of
the Product (i.e., indicating the
number of doses sold, the number doses returned and the number of unsold
doses), with a detailed description of the applicable reconciliation
calculations. If the reconciliation calculation indicates that any amount is
owed to MedImmune, Wyeth will pay MedImmune that amount within 30 days after receiving
the reconciliation calculation.  If the
reconciliation calculation indicates that any amount is owed to Wyeth,
MedImmune will pay Wyeth that amount within 30 days after receiving the
reconciliation calculation.  No later
than 30 days after the end of each Flu Season, but in any event by July 31
of the applicable Flu Season, Wyeth will provide MedImmune with a written
description of the final aggregate transfer payments due to MedImmune for that
Flu Season  describing Wyeth sales
of the Product (i.e., indicating
the number of doses sold, the number doses returned and the number of unsold
doses), and a detailed description of the applicable reconciliation
calculations.  If the reconciliation
calculation indicates any amount is owed to MedImmune, Wyeth will pay MedImmune
that amount within 30 days after receiving the reconciliation calculation. If
the reconciliation calculation indicates that any amount is owed to Wyeth,
MedImmune will pay Wyeth that amount within 30 days after receiving the
reconciliation calculation.  For the
purpose of this Section 2.4(a), the estimated transfer price
payment for each shipment will be calculated as set forth in Section 2.4(b),
and the aggregate actual transfer price and reconciliation for the applicable
Flu Season  will be calculated as
set forth in Section 2.4(c).


 


(b)                                  Estimated Transfer Price
Payment Calculations.  The estimated transfer price payment per
shipment of doses accepted by Wyeth  will
be calculated as follows:


 


TPe = Das  ́ Pe


 


where:


 


TPe is the estimated transfer price per shipment;


 


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Das is the number of doses of MedImmune-Manufactured Product accepted by
Wyeth in the shipment; and


Pe is the estimated average transfer price per
dose, which is constant throughout any given Flu Season and calculated as
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) of the estimated Net Sales
attributable to MedImmune-Manufactured Product for the Flu Season divided by
the Forecast of MedImmune-Manufactured Product for that Flu Season.


 


The
total estimated payment amount due upon acceptance of any shipment will be the
estimated transfer price payment for that shipment (TPe) plus
the estimated payment for unsold and returned doses for that shipment (to be
determined by mutual agreement of the parties as a reasonable estimate of the
corresponding actual amounts to be calculated under Section 2.4(c)).  For the purpose of determining the estimated
average transfer price per dose (Pe) for a particular Flu Season,
the JCC (or ICC, as applicable) will calculate and provide the parties with the
Pe
for that Flu Season no later than 90 days before the beginning of the
applicable Flu Season.  For the purpose
of this Section 2.4(b), the beginning of the Flu Season in the case
of the Northern Hemisphere will be deemed to be September 1  and for all other regions will be
determined by mutual agreement of the parties.


 


(c)                                  Calculations of Aggregate
Actual Transfer Price, Unsold Price and Return Price Payments; Reconciliation.  The total
amount due to MedImmune for each Flu Season starting with the fifth Flu Season
will be the aggregate actual transfer price payment plus the unsold price
payment plus the return price payment as calculated in accordance with this Section 2.4(c)
(i.e., TPa + UP + RP, as such terms are
defined below in this Section 2.4(c)).


 


(1)                                 Aggregate Actual Transfer
Price.  The
aggregate actual transfer price payment for the applicable Flu Season  will be calculated as follows:


 


TPa = Ds  ́ Pa


 


where:


 


TPa is the aggregate actual transfer price for the applicable Flu Season;


Ds is the greater of (A) (CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED) of the doses accepted by Wyeth during the
applicable Flu Season or (B) the total number of doses of
MedImmune-Manufactured Product sold by Wyeth during the Flu Season; and


Pa is the actual average transfer price per
dose, which is calculated as (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) of (A)
the actual Net Sales attributable to MedImmune-Manufactured Product for the Flu
Season divided by (B) the total number of doses of
MedImmune-Manufactured Product sold by Wyeth during the Flu Season.


 


(2)                                 Unsold Price.  The
unsold price payment for the applicable Flu Season  will be calculated as follows:


 


UP = Da  ́ Pa


 


where:


 


UP is the
unsold price for the applicable Flu Season;


Du is the lesser of (1) the total number of
doses of MedImmune-Manufactured Product accepted by Wyeth but not sold during
the applicable Flu Season or (2) (CONFIDENTIAL TREATMENT HAS


 


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BEEN
REQUESTED) of the total number of doses of MedImmune-Manufactured Product
accepted by Wyeth during the Flu Season; and


Pu is the price per dose to be paid for each
unsold dose, which is the lesser of (1) (CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED) of MedImmune’s Manufacturing Costs for the unsold doses divided
by the number of unsold doses or (2) the Cost of Goods Cap.


 


(3)                                 Return Price.  The
return price payment for the applicable Flu Season  will be calculated as follows:


 


RP = Dr  ́ Pr


 


where:


 


RP is the
return price for the applicable Flu Season;


Dr is the number of doses of MedImmune-Manufactured Product returned
during the Flu Season; and


Pr is the price per dose to be paid for each dose returned, which is
based on the number of doses of MedImmune-Manufactured Product sold during the
Flu Season as set forth in the following table:


 


	
  Number of Doses of MedImmune-

  Manufactured Product Sold During

  the Flu Season

  	
   

  	
  Pr

  
	
   

  	
   

  	
   

  
	
  (CONFIDENTIAL
  TREATMENT

  HAS BEEN REQUESTED)

  or less

  	
   

  	
  $(CONFIDENTIAL
  TREATMENT

  HAS BEEN REQUESTED)

  
	
   

  	
   

  	
   

  
	
  (CONFIDENTIAL
  TREATMENT

  HAS BEEN REQUESTED)

  	
   

  	
  $(CONFIDENTIAL
  TREATMENT

  HAS BEEN REQUESTED)

  
	
   

  	
   

  	
   

  
	
  (CONFIDENTIAL
  TREATMENT

  HAS BEEN REQUESTED)

  or more

  	
   

  	
  $(CONFIDENTIAL
  TREATMENT

  HAS BEEN REQUESTED)

  



 


provided that, the price per dose in the preceding table
will be adjusted on July 1, 2004 and every July 1 afterwards during
the term of the Supply Agreement by increasing or decreasing such price per
dose by a percentage equal to one-half of any cumulative percentage increase or
decrease, respectively, in the Consumer Price Index as of such adjustment date,
as compared to the Consumer Price Index in effect on July 1, 2003.


 


If the interim payment due to MedImmune under this Section 2.4(c)
for a Flu Season (i.e., TPa + UP + RP) exceeds the
estimated payment made to MedImmune under Section 2.4(b) for that
Flu Season then the amount due to MedImmune will be (TPa + UP + RP)  minus the
estimated payment.  Conversely, if the
estimated payment exceeds (TPa
+ UP + RP) then the amount
due to Wyeth will be the estimated payment minus (TPa + UP + RP).


 


If the final payment due to MedImmune under this Section 2.4(c)
for a Flu Season exceeds the estimated payment made to MedImmune under Section 2.4(b)
for that Flu Season (as adjusted to reflect


 


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any interim payment), then that excess will be the amount due to
MedImmune at the final payment date. 
Conversely, if the estimated payment made to MedImmune under Section 2.4(b)
for that Flu Season (as adjusted to reflect any interim payment) exceeds the
final payment due to MedImmune under this Section 2.4(c), then that
excess will be the amount due to Wyeth at the final payment date.


 


To the extent any amount is due to MedImmune in respect of Late Doses,
such amount will be added to TPa in the interim and reconciliation
calculations above.


 


2.5                               Excess Doses. 
Wyeth has the right but not the obligation to accept any doses that are
delivered in excess of the Forecast/Modified Forecast (such doses, “Excess Doses”).  If Wyeth, in its sole discretion, accepts any Excess Doses, then
the Forecast for that Flu Season will be deemed to have been increased to
include such accepted Excess Doses.


 


3.                                      CAIV-T Research and
Development.  Notwithstanding anything to the contrary
regarding allocation of research and development costs set forth in the U.S.
Agreement or the International Agreement, the parties agree that they will
share certain expenses for the research and development of a liquid trivalent
cold-adapted intranasal influenza vaccine (“CAIV-T”)  in
accordance with the terms of this Section 3.  In exchange, each party agrees that it has a
continuing obligation to provide to the other all data and other materials
related to all studies, trials and tests related to the research and development
of CAIV-T (whether completed, on-going or proposed and domestic or
international).  The parties agree that
the design and execution of all studies, trials and tests related to CAIV-T
that have either not been initiated as of the date of execution of this Master
Amendment or have been initiated but are subsequently modified will be reviewed
and agreed upon by the JDC and then submitted to the JCC for final review and
approval.


 


3.1                               Milestone Payments. 
MedImmune agrees to make a payment of $10,000,000 to Wyeth no later than
February 1, 2004 in recognition of CAIV-T research expenses incurred by
Wyeth through December 31, 2003 and for which Wyeth has no further service
obligation to MedImmune.  In addition,
MedImmune agrees to make the following milestone payments to Wyeth promptly
after achievement of the corresponding milestone:


 


	
  Milestone

  	
   

  	
  Milestone
  Payment

  
	
  FDA’s
  acceptance for filing of the first PLA for CAIV-T

  	
   

  	
  $(CONFIDENTIAL
  TREATMENT HAS BEEN REQUESTED)

  
	
   

  	
   

  	
   

  
	
  First
  approval by the FDA of a PLA for CAIV-T

  	
   

  	
  $(CONFIDENTIAL
  TREATMENT HAS BEEN REQUESTED)

  



 


3.2                               Research and Development
Expenses.  Notwithstanding anything in Section 6.4
of the U.S. Agreement to the contrary, R&D Expenses that are incurred on or
after January 1, 2004 and relate to studies, tests or trials that support
regulatory filings related to CAIV-T exclusively in the United States and in no
other jurisdictions (“U.S.-Only Expenses”),
will be borne (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED). Any R&D Expenses
that are incurred on or after January 1, 2004 and relate to studies, tests
or trials that support regulatory filings related to CAIV-T in the United
States and one or more other jurisdictions (“Multi-Jurisdiction Expenses”) will be borne (CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED).  Any
R&D Expenses that are incurred after January 1, 2004 and relate to
studies, tests or trials to support regulatory filings related to CAIV-T
exclusively in jurisdictions outside of the United States (“Ex-U.S. Expenses”) will be borne
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED). 
For the purposes of the three


 


8

















 


preceding
sentences, the term “exclusively” refers solely to the jurisdiction limitation
for support of regulatory filings and does not prohibit either Party from
fulfilling any disclosure obligations to regulatory authorities in any
jurisdiction.


 


For clarity, a complete list of those on-going studies, trials and
tests related to CAIV-T for which R&D Expenses are expected to be incurred
on or after January 1, 2004 and the amounts that have been budgeted for
such studies, trials and tests  will
be reviewed for approval by the JDC and the JCC no later than December 31,
2003 and will be categorized as U.S.-Only Expenses, Multi-Jurisdiction Expenses
or Ex-U.S. Expenses, if and when approved. 
In accordance with the procedure described in the introductory paragraph
of this Section 3, all other studies, trials and tests to be
included in the Development Plan and related to CAIV-T will be approved by the
JDC or IDC, as applicable and JCC or ICC, as applicable and the related
expenses will be designated by the JDC or IDC (subject to final approval by the
JCC or ICC) as U.S.-Only Expenses, Multi-Jurisdiction Expenses or Ex-U.S.
Expenses, as applicable, at the time of such approval.  The Party conducting or sponsoring the
study, trial or test will notify the other in writing promptly if the expenses
exceed or are expected to exceed the budgeted amount approved by the JCC or ICC
by greater than a percentage amount (which percentage amount will be set for
the JCC and ICC by the JCC on or before December 31, 2003) with an
explanation of the reason for the variance. 
Amounts in excess of the percentage amount above the budgeted amount
approved by the JCC or ICC will be borne by the Party conducting the applicable
study, trial or test unless a revised budget is approved by the JCC or ICC,
after a good faith evaluation of the explanation of the reason for the
variance.  The Party incurring the
expense will invoice the other on a quarterly basis and payment by the other
Party of its share of such expenses, as provided in this Section 3.2, will
be due within 30 days after receipt of such invoice.


 


4.                                      Elimination of Sunset
Royalties; Related Adjustments of Agreement Terms. This Section 4 amends the U.S.
Agreement and the International Agreement.


 


4.1                               Elimination of  Sunset Royalties. 
Section 12.4 of the U.S. Agreement (under the caption Sunset
Royalites) is hereby deleted.


 


4.2                               Term of U.S. Agreement.


 


(a)                                  Term Extension.  The parties
agree that for the purposes of the U.S. Agreement there is no “Launch Date Flu
Season” and that the 2003-2004 Flu Season is the “First Full Flu Season.”  In addition, Section 1.16 of the U.S.
Agreement (as set forth in the First Amendment of the U.S. Agreement) is hereby
deleted and replaced with the following new Section 1.16:


 


“1.16                  “Co-Promotion Term” means the period commencing with the
2003-2004 Flu Season, and terminating upon the earlier of (a) the conclusion of
the eleventh Flu Season (i.e.,
May 1, 2014), or (b) termination of this Agreement pursuant to
Section 19.2, 19.3, 19.4 or 19.5, or as otherwise agreed by the Parties in
writing.”


 


For
clarity, under the terms of this amended Section 1.16, the term of the
U.S. Agreement will expire upon the completion of the eleventh Flu Season,
unless terminated earlier in accordance with the terms of the U.S. Agreement
(as amended by this Master Amendment). 
Since the first Flu Season is 2003-2004, the U.S. Agreement will expire
(unless terminated) upon the conclusion of the 2013-2014 Flu Season.


 


9

















 


(b)                                  Elimination of Options to
Extend Co-Promotion Term.  Section 19.8 of the U.S. Agreement is
hereby deleted (in order to preserve the numbering of subsequent provisions,
Section 19.8 of the U.S. Agreement is reserved).


 


4.3                               Royalty Rate Adjustment.  The
first paragraph of Section 12.1(b) of the U.S. Agreement (including
the royalty rate table) is hereby deleted and replaced with the following
paragraph and table:


 


“(b)                           Sales During the 2003-2004
Flu Season and Thereafter.  With respect to Net Sales occurring during
the 2003-2004 Flu Season and thereafter, Wyeth shall pay royalties to MedImmune
on Annual Net Sales of all aggregated Products in the Territory at the
following marginal rates applicable to the Flu Season designated in the table
below:


 


10

















 


	
   

  	
   

  	
  Year in
  Which Flu Season Begins

  
	
   

  	
   

  	
  2003 to
  2009

  	
   

  	
  2010

  	
   

  	
  2011

  	
   

  	
  2012

  	
   

  	
  2013

  
	
  For
  Annual Net Sales up to $(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)

  	
   

  	
  (CONFIDENTIAL
  TREATMENT HAS BEEN REQUESTED)

  	
   

  	
  (CONFIDENTIAL
  TREATMENT HAS BEEN REQUESTED)

  	
   

  	
  (CONFIDENTIAL
  TREATMENT HAS BEEN REQUESTED)

  	
   

  	
  (CONFIDENTIAL
  TREATMENT HAS BEEN REQUESTED)

  	
   

  	
  (CONFIDENTIAL
  TREATMENT HAS BEEN REQUESTED)

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  For
  the portion of Annual Net Sales in excess of $(CONFIDENTIAL TREATMENT HAS
  BEEN REQUESTED)  and not exceeding
  $(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)

  	
   

  	
  (CONFIDENTIAL
  TREATMENT HAS BEEN REQUESTED)

  	
   

  	
  (CONFIDENTIAL
  TREATMENT HAS BEEN REQUESTED)

  	
   

  	
  (CONFIDENTIAL
  TREATMENT HAS BEEN REQUESTED)

  	
   

  	
  (CONFIDENTIAL
  TREATMENT HAS BEEN REQUESTED)

  	
   

  	
  (CONFIDENTIAL
  TREATMENT HAS BEEN REQUESTED)

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  For
  the portion of Annual Net Sales in excess of $(CONFIDENTIAL TREATMENT HAS
  BEEN REQUESTED)  and not exceeding
  $(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)

  	
   

  	
  (CONFIDENTIAL
  TREATMENT HAS BEEN REQUESTED)

  	
   

  	
  (CONFIDENTIAL
  TREATMENT HAS BEEN REQUESTED)

  	
   

  	
  (CONFIDENTIAL
  TREATMENT HAS BEEN REQUESTED)

  	
   

  	
  (CONFIDENTIAL
  TREATMENT HAS BEEN REQUESTED)

  	
   

  	
  (CONFIDENTIAL
  TREATMENT HAS BEEN REQUESTED)

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  For
  the portion of Annual Net Sales in excess of $(CONFIDENTIAL TREATMENT HAS
  BEEN REQUESTED)

  	
   

  	
  (CONFIDENTIAL
  TREATMENT HAS BEEN REQUESTED)

  	
   

  	
  (CONFIDENTIAL
  TREATMENT HAS BEEN REQUESTED)

  	
   

  	
  (CONFIDENTIAL
  TREATMENT HAS BEEN REQUESTED)

  	
   

  	
  (CONFIDENTIAL
  TREATMENT HAS BEEN REQUESTED)

  	
   

  	
  (CONFIDENTIAL
  TREATMENT HAS BEEN REQUESTED)

  



“


4.4                               Adjustments to the
International Agreement.


 


(a)                                  Term.  Section 18.1(a)
of the International Agreement is hereby amended by deleting “December 31,
2012” and inserting in its place “June 30, 2015.”


 


11

















 


(b)                                  Termination Without Cause.  Section 18.3(b)
of the International Agreement is hereby deleted in its entirety and replaced
by the following:  “(b) at any time,
with or without cause, upon at least 12 months prior written notice to
MedImmune.”


 


(c)                                  Certain Adjustments to
Option Price.  A new Section 18.8(b)(iii) is hereby
added to the International Agreement as follows:


 


“(iii)                     Credit for (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) Option Years.  If
Wyeth elects to exercise its option (CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED), then Wyeth will receive a credit for each such extension year in
the amount of $(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) to be applied upon
the reconciliation for that extension year described in
Section 18.8(b)(ii).  This credit
will not, in any event, reduce the Option Price for the applicable extension
year below $(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) and Wyeth acknowledges
and agrees that the Option Price advance payment made under
Section 18.8(i), if and when made, will be deemed to be
non-refundable.  To the extent a balance
is remaining after application of the credit consistent with the preceding
sentences of this Section 18.8(iii), Wyeth will make payment when due in
accordance with Section 18.8(b)(ii) and if there is any residual credit,
that credit will be forfeited.  For
clarity, any residual credit after (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
will not be applicable against the Option Price for (CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED) .”


 


5.                                      Full Force and Effect. 
Except as set forth in this Master Amendment, in all other respects the
Agreements remain in full force and effect.


 


6.                                      Counterpart; Facsimile
Signatures.  The Parties agree that this Master Amendment
may be executed in counterparts and by facsimile.


 


[Remainder of this page intentionally left blank.]


 


12

















 


MedImmune and Wyeth have caused this Master Amendment to be executed as
of the date first written above by their respective duly authorized officers.


 


	
  Wyeth, acting through its

  Wyeth Pharmaceuticals Division

  	
  MedImmune Vaccines, Inc.

  
	
   

  	
   

  
	
   

  	
   

  
	
  By:

  	
  /s/
  Geno J. Germano

  	
   

  	
  By:

  	
  /s/
  Melvin D. Booth

  	
   

  
	
   

  	
  Name:

  	
  Geno
  J. Germano

  	
   

  	
   

  	
  Name:

  	
  Melvin
  D. Booth

  	
   

  
	
   

  	
  Title:

  	
  E.V.P./GM
  Wyeth Vaccines

  	
   

  	
   

  	
  Title:

  	
  President
  and COO