Exhibit 10.1
THIRD AMENDMENT TO
CO-PROMOTION AGREEMENT
This Third Amendment (the
“THIRD AMENDMENT” ), effective as of August 26,
2005 (the “THIRD AMENDMENT EFFECTIVE DATE” ), is
entered into by and between ABBOTT LABORATORIES, through its ROSS
PRODUCTS DIVISION ( “ABBOTT” ), and MEDIMMUNE,
INC. ( “MEDIMMUNE” ).
Recitals
:
A. ABBOTT
and MEDIMMUNE are parties to a CO-PROMOTION AGREEMENT, effective as
of November 26, 1997 (the “Agreement” ), which
was amended effective as of July 31, 2000 and amended effective as
of November 29, 2001, each of which amendments is no longer in
effect; and
B. ABBOTT
and MEDIMMUNE desire to amend the Agreement as set forth in greater
detail in this THIRD AMENDMENT.
In consideration of the mutual
promises and covenants set forth in this THIRD AMENDMENT, ABBOTT
and MEDIMMUNE agree as follows:
Agreement
:
1.
Definitions Generally . All fully capitalized terms
have the same meaning as in the Agreement, except to the extent
modified by or defined in this THIRD AMENDMENT.
2.
Territory Definition . Section 1(i) of the
Agreement is rewritten in its entirety to read as
follows:
--(i)
“ TERRITORY ”
shall mean the United States of America, including its territories,
possessions and commonwealths.
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3.
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Additional Defined
Terms .
The following is added to Section
1 of the Agreement:
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--(l)
“ NUMAX ” shall
mean the product candidate being developed by MEDIMMUNE, known as
of the THIRD AMENDMENT EFFECTIVE DATE as MEDI-524, including any
functional derivative, delivery form, dosage form, formulation,
improvement or presentation of such product candidate developed by
or on behalf of MEDIMMUNE following the THIRD AMENDMENT EFFECTIVE
DATE.
--(m)
“ EXTENDED PERIOD
” shall mean the period beginning on September 1, 2008 and
ending on the earlier of: (i) the date on which the U.S. Food and
Drug Administration (FDA) grants approval to market NUMAX in the
TERRITORY, or (ii) August 31, 2010.
--(n)
“ DEMAND SALES ”
shall mean all sales of PRODUCT (in 100 mg equivalent vials)
shipped from wholesalers, distributors and home health care
companies to hospitals and any and all other customers, as reported
by IMS HEALTH Global Systems, plus all other sales of PRODUCT
shipped to any and all end users.--
4. Incentive Plan . Section 2.3(e) of the Agreement is rewritten in its entirety to
read as follows:
--(e)
For the promotion of PRODUCT during
the period from January 1, 2006 through June 30, 2006, in addition
to an incentive plan customarily used by ABBOTT (or the substantial
equivalent per ABBOTT’s reasonable judgment) for promotion of
PRODUCT in the two (2) YEARS preceding the THIRD AMENDMENT
EFFECTIVE DATE, ABBOTT shall allocate [***] for a special incentive
plan for the sales force of ABBOTT that is promoting PRODUCT. The
incremental incentive plan will be designed to drive a [***]
increase in DEMAND SALES to match a [***] increase in NET SALES
(translated to 100 mg equivalent vials). (For clarity, the DEMAND
SALES and NET SALES (translated to 100 mg equivalent vials)
incentive plan volume goals for next season are both [***] 100 mg
equivalent vials of PRODUCT, assuming the same ending inventory
level, at all wholesalers and distributors in the aggregate as
customarily calculated, as the ’04-’05 season, which
was [***] 100 mg equivalent vials.) Details of such special
incentive plan shall be agreed to by ABBOTT and MEDIMMUNE and
attached to this THIRD AMENDMENT as Exhibit A , within
thirty (30) days after the THIRD AMENDMENT EFFECTIVE DATE. ABBOTT
shall bear the entire cost and expense for any amounts paid under
the special incentive plan.
a. In Section 2.4(a) of the
Agreement, delete “In each YEAR, in which ABBOTT is
co-promoting PRODUCT, in lieu of any other compensation” and
in its place insert “During the TERM”.
b. Section 2.4(a)(x) of the
Agreement is amended by adding the following at the end thereof
immediately after the second use of the word
“THRESHOLD”:
--; provided, however , that
no amount shall be due under this Section 2.4(a)(x) for NET
SALES after December 31, 2006.--
6. Co-Promotion Payment Amounts
. Section 2.4(a)(y) of the Agreement is rewritten in its entirety as
follows:
--for the [***] of the portion of
NET SALES above the THRESHOLD for NET SALES that occur between
[***] and [***] of the portion of NET SALES above the THRESHOLD for
NET SALES that occur between [***]; provided ,
however , that whether NET SALES are above or below the
THRESHOLD shall be determined based on NET SALES over the entire
period from [***]; and
for the [***],[***]of the NET SALES
above the THRESHOLD for such period;
provided, however
, that no amount shall be due under
this Section 2.4(a)(y) for NET SALES after December 31,
2006; and--
7. Thresholds . Section 2.4(a)(z) of the Agreement is amended by adding the
following at the end thereof:
--; provided, however , that
(i) the THRESHOLD for the YEAR beginning July 1, 2005 shall
be[***]; and (ii) notwithstanding any other definition in this
Agreement to the
contrary, the term
“YEAR” as used in this Agreement for the period
beginning as of July 1, 2006, shall mean the six-month period from
July 1, 2006 through December 31, 2006, and the THRESHOLD for such
period shall be [***].--
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8.
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Milestones
. The following is added to Section 2.4 of
the Agreement:
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--(d)
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Intentionally omitted.
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--(f)
Within ten (10) days after the THIRD
AMENDMENT EFFECTIVE DATE, MEDIMMUNE shall pay [***] to
ABBOTT.
--(g)
In the event that DEMAND SALES of
PRODUCT in the TERRITORY for the calendar quarter from [***] reach
[***] 100 mg equivalent vials, then MEDIMMUNE shall notify ABBOTT
within ten (10) days of determining that such sales milestone has
been achieved (such notice in no event to be later than ten (10)
days after [***]), ABBOTT shall invoice MEDIMMUNE for [***] and
MEDIMMUNE shall pay such amount to ABBOTT no later than the later
of thirty (30) days after the receipt of such invoice or
[***].
--(h)
During the period from[***], ABBOTT,
at its own cost and expense, shall provide to MEDIMMUNE assistance
related to and transfer information and material regarding data in
ABBOTT’s possession relevant to the promotion of the PRODUCT
to help facilitate the transition of the sales and
marketing