EXHIBIT 10.1
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
FIRST AMENDMENT TO CO-PROMOTION AGREEMENT
This First Amendment to Co-Promotion Agreement (hereinafter "Amendment") is
made and effective this 19 day of January, 2000, by and between Sepracor Inc.,
having its principal offices at ▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇
▇▇▇▇▇ ("Sepracor"), and ▇▇▇▇▇▇ Laboratories Inc., through its ▇▇▇▇ Products
Division, having its principal offices at ▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇▇▇
▇▇▇▇▇ ("Abbott").
WHEREAS, Sepracor and Abbott executed a Co-Promotion Agreement effective as
of November 18, 1999 (hereinafter referred to as "Agreement').
NOW, THEREFORE, Sepracor and Abbott hereby agree to amend the Agreement as
follows:
1. All terms in this Amendment, unless otherwise defined herein, shall have
the same meaning as set forth in the Agreement.
2. Section 9.1 of the Agreement is deleted in its entirety, and a new
Section 9.1 is added in lieu thereof which reads in its entirety as
follows:
9.1 PRODUCT RIGHTS EX-U.S. In the event Sepracor desires to have an entity
other than Sepracor, or a Sepracor Affiliate market, sell, distribute,
or promote the Product to the Pediatric Market in any country outside
the Territory except Italy, Vatican City and San Marino, Sepracor
shall give Abbott first notice of the opportunity to have Abbott
market, sell, distribute, promote, co-promote or co-market the Product
to the Pediatric Market in such country through a right of first
negotiation for not more than thirty (30) calendar days after
Sepracor's notice to Abbott hereunder. If during the Term of this
Agreement, the rights relating to sale and distribution of Product in
Italy, Vatican City and San Marino granted to a Third Party under an
existing agreement, revert to Sepracor, such countries shall
automatically be subject to the terms of the preceding sentence,
beginning at the time such rights revert to Sepracor.
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3. Section 9.2 of the Agreement is deleted in its entirety, and a new Section
9.2 is added in lieu thereof which reads in its entirety as follows:
9.2 PRODUCT RIGHTS TO GERIATRIC MARKET. In the event Sepracor desires to
have an entity other than Sepracor or a Sepracor Affiliate market,
sell, distribute, or promote the Product specifically for use by the
Geriatric Market in the Territory (and, if Abbott and Sepracor enter
into any agreement with respect to the Geriatric Market in the
Territory, in any country outside the Territory except, Italy, Vatican
City and San Marino), Sepracor shall give Abbott first notice of the
opportunity to have Abbott market, sell, distribute, promote,
co-promote or co-market the Product for use by Geriatric Market in the
Territory (and, if Abbott and Sepracor enter into any agreement with
respect to the Geriatric Market in the Territory, in any country
outside the Territory except Italy, Vatican City and San Marino)
through a right of first negotiation for not more than thirty (30)
calendar days after Sepracor's notice to Abbott hereunder. If during
the Term of this Agreement, the rights relating to sale and
distribution of Product in Italy, Vatican City and San Marino granted
to a Third Party under an existing agreement, revert to Sepracor, such
countries shall automatically be subject to the terms of the preceding
sentence, beginning at the time such rights revert to Sepracor.
4. Schedule 10.4.6 of the Agreement is deleted in its entirety, and a new
Schedule 10.4.6, which reads in its entirety as set forth in Attachment A
hereto, is added in lieu thereof.
5. Except as expressly amended hereby, the Agreement shall be and remain in
full force and effect in accordance with its terms.
IN WITNESS WHEREOF, the parties hereto have caused this two (2) page
Amendment, with Attachment A, to be executed in duplicate by their duly
authorized representatives and entered into and effective as of the day and year
first set forth above.
SEPRACOR INC. ▇▇▇▇▇▇ LABORATORIES INC.
By:/s/ ▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇'▇▇▇▇ By:/s/ ▇▇▇ ▇▇▇▇▇▇▇▇
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▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇'▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇▇▇
President and Chief Operating Officer President, ▇▇▇▇ Products Division
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ATTACHMENT A
AMENDED SCHEDULE 10.4.6
OTHER AGREEMENTS REGARDING PRODUCT
1. Sales Force Services Agreement between Innovex Inc. and Sepracor Inc.,
effective August 1, 1999.
2. Development, Supply and License Agreement between Valeas SpA, and Sepracor
Inc., effective June 1, 1998.
SECOND AMENDMENT TO CO-PROMOTION AGREEMENT
This Second Amendment to Co-Promotion Agreement (hereinafter "Amendment")
is made and effective as of January 1, 2001, by and between Sepracor Inc.,
having its principal offices at ▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇
▇▇▇▇▇ ("Sepracor"), and ▇▇▇▇▇▇ Laboratories Inc., through its ▇▇▇▇ Products
Division, having its principal offices at ▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇▇▇
▇▇▇▇▇ ("Abbott").
WHEREAS, Sepracor and Abbott executed a Co-Promotion Agreement effective as
of November 18, 1999 (hereinafter referred to as "Agreement");
WHEREAS, prior to January 1, 2001, total sales of Product have been such
that payment of Commission to Abbott has not required reference to the
definitions of Pediatric Market (Section 1.31) or Pediatric Sales (Section 1.32)
in the Agreement; and
WHEREAS, the parties expect that sales of Product will reach the level
where reference to such definitions will be required in order for the Commission
payments to be properly calculated; and
WHEREAS, the parties have agreed to lists of physicians that shall
constitute a basis for Commission payments to Abbott, such lists not directly
corresponding to those called for in the Agreement as originally written;
NOW, THEREFORE, Sepracor and Abbott hereby agree to amend the Agreement as
follows:
1. All terms in this Amendment, unless otherwise defined herein, shall
have the same meaning as set forth in the Agreement.
2. Section 1.31 of the Agreement is deleted in its entirety, and a new
Section 1.31 is added in lieu thereof which reads in its entirety as
follows:
1.31 "PEDIATRIC MARKET" means pediatricians identified by Medical
Education number (a list of such pediatricians, a "Pediatrician List",
to be agreed to by the Marketing Committee and amended from time to
time, as appropriate), primary care physicians with high birth
practices identified by Medical Education number (a list of such
physicians, a "PCP List", to be agreed to by the Marketing Committee
and amended from time to time, as appropriate), primary care
physicians with high birth practices identified by Medical Education
number and called upon by both Abbott and Sepracor (a list of such
physicians, a "Common PCP List", to be agreed to by the Marketing
Committee and amended from time to time, as appropriate), and Abbott
Targeted Hospitals, and clinics, mail-order and staff model health
maintenance organizations for the purpose of pediatric care; PROVIDED,
HOWEVER, that all pediatric allergists and pediatric pulmonologists
are excluded from the Pediatric Market; FURTHER, PROVIDED, HOWEVER,
that Abbott
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shall have a right of first refusal to add pediatric allergists,
pediatric pulmonologists, or both, to the Pediatric Market in the
event that during the Term, Sepracor decides that it would like sales
personnel other than Sepracor Representatives to promote Product to
pediatric allergists, pediatric pulmonologists, or both, as
appropriate, and in such case, expansion of the Pediatric Market to
include one or both of pediatric allergists and pediatric
pulmonologists shall be discussed by the Marketing Committee.
3. Section 1.32 of the Agreement is deleted in its entirety, and a new
Section 1.32 is added in lieu thereof which reads in its entirety as
follows:
1.32 "PEDIATRIC SALES" means sales of Product by Sepracor and its
Affiliates, as calculated by adding (a) the product determined by
multiplying the Average Net Selling Price/Dose Vial or Average Net
Selling Price/Dose Bottle during an applicable period by the sum of:
the number of unit dose vials or multidose bottles of Product, as
appropriate, sold during such period through pediatricians identified
on the Pediatrician List,
the number of unit dose vials or multidose bottles of Product, as
appropriate, sold during such period through those primary care
physicians with high birth practices identified on the PCP List, and
one half of the number of unit dose vials or multidose bottles of
Product, as appropriate, sold during such period through primary care
physicians with high birth practices identified on Common PCP List,
that are dispensed by retail drug stores (independent, chains, food
and mass merchandise stores), clinics, and mail-order and staff model
health maintenance organizations {[determined by multiplying the
number of prescriptions generated by such identified primary care
physicians and so dispensed (using Xponent data) by the average number
of unit dose vials per pediatric script [which is equal to the unit
dose ratio (the numerator of which is the total milliliter volume of
the Product dispensed in unit dose vials to fill pediatric
prescriptions, and the denominator of which is dose size in
milliliters) divided by the number of unit dose vial prescriptions
written by pediatricians] or by the average number of multidose
bottles per pediatric script [which is equal to the multidose ratio
(the numerator of which is the total milliliter volume of the Product
dispensed in multidose bottles to fill pediatric prescriptions, and
the denominator of which is the bottle volume in milliliters) divided
by the number of multidose bottle prescriptions written by
pediatricians], as appropriate, (using the National Prescription
Audit)}, and (b) pediatric purchases of Product by hospitals, which
shall be calculated by multiplying the number of unit dose vials or
multidose bottles of Product, as appropriate, sold to Abbott Targeted
Hospitals during an applicable period as reported by Drug Distribution
Data by the Average Net Selling Price/Dose Vial or Average Net Selling
Price/Dose Bottle, as appropriate, during such period and by the
fraction equal to the number of unit dose vials or multidose bottles,
as appropriate,
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prescribed by pediatricians in the retail segment (as reported by the
National Prescription Audit) divided by the number of all unit dose
vials or multidose bottles, as appropriate, prescribed in the retail
segment (as reported by the National Prescription Audit) during such
period. For example purposes only, a mock sample calculation of
Pediatric Sales is set forth in Schedule 1.32 hereto.
4. The Pediatrician List, the PCP List, and the Common PCP List are set
forth in the file identified as "fff_49523_ross05_29_01.xls,
transmitted to Abbott by ▇▇▇▇ ▇▇▇▇▇▇▇▇▇ on May 29, 2001, which is
incorporated herein by reference.
5. The lists referred to in the letter of November 18, 1999 from ▇▇.
▇▇▇▇▇▇▇ ▇. ▇'▇▇▇▇ to ▇▇. ▇▇▇ ▇▇▇▇▇▇▇▇ shall be disregarded.
6. Except as expressly amended hereby, the Agreement shall be and remain
in full force and effect in accordance with its terms.
IN WITNESS WHEREOF, the parties hereto have caused this three (3) page
Amendment, incorporating by reference the file referenced in paragraph 4 above,
to be executed in duplicate by their duly authorized representatives and entered
into and effective as of the day and year first set forth above.
SEPRACOR INC. ▇▇▇▇▇▇ LABORATORIES INC.
By:/s/▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇'▇▇▇▇ By:/s/▇▇▇ ▇▇▇▇▇▇▇▇
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▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇'▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇▇▇
President and Chief Operating Officer President, ▇▇▇▇ Products Division
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THIRD AMENDMENT TO CO-PROMOTION AGREEMENT
THIS THIRD AMENDMENT to Co-Promotion Agreement (hereinafter "Third Amendment")
is made and effective as of March 19, 2004, by and between Sepracor Inc., having
its principal offices at ▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ ("Sepracor")
and ▇▇▇▇▇▇ Laboratories, Inc., through its ▇▇▇▇ Products Division, having its
principal offices at ▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ ("Abbott").
WHEREAS, Sepracor and Abbott executed a Co-Promotion Agreement effective as of
November 18, 1999, as subsequently amended by that certain January 19, 2000
First Amendment to Co-Promotion Agreement ("First Amendment") and that certain
January 1, 2001 Second Amendment to Co-Promotion Agreement ("Second Amendment")
(said Co-Promotion Agreement, First Amendment and Second Amendment shall
hereinafter be collectively referred to as the "Agreement");
WHEREAS, the parties desire to terminate the Agreement effective December 31,
2004 and adjust the subsequent residual payments
NOW, THEREFORE, Sepracor and Abbott hereby agree to further amend the Agreement
as follows:
1. All terms in this Third Amendment, unless otherwise defined herein,
shall have the same meaning as set forth in the Agreement.
2. By execution of this Third Amendment Sepracor hereby withdraws, waives
and releases Abbott from all claims set forth in the October 9, 2003
correspondence from ▇▇▇▇ ▇. ▇▇▇▇▇ of Sepracor to the attention of ▇▇.
▇▇▇▇ ▇▇▇▇▇ of Abbott (the "Notice of Dispute"). In addition, by
execution of this Third Amendment each Party hereby withdraws, waives
and releases the other from all claims that could have been brought by
either Party and related to the other Party's co-promotion efforts
under the Agreement through the effective date of this Third
Amendment, whether known or unknown.
3. Section 3.1.1.1, PROMOTION TO PEDIATRICIANS, is hereby amended by
deleting the reference to "Product and one other pharmaceutical
product will be part of such calling pattern and will be detailed
before any other products" in lines 7-9 of the section.
4. Section 3.4 of the Agreement, ABBOTT REPRESENTATIVES' INCENTIVE
COMPENSATION, is hereby amended by adding the following language to
the end of the section:
The other provisions in this Section notwithstanding, for the
last two (2) trimesters of the 2004 Sales Year (May 1, 2004
through December 31, 2004), Abbott shall set the incentive
weighting bonus for the Product for all Abbott Representatives at
[**] percent ([**]%). Abbott shall take commercially reasonable
steps to communicate this incentive weighting
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bonus percentage for the Product to the Abbott Representatives
prior to the start of the second trimester of the 2004 Sales
Year.
5. Section 12.1, INITIAL TERM, is hereby deleted from the Agreement in
its entirety and replaced with the following:
12.1 TERM. This Agreement shall commence as of the Effective Date
and shall remain in full force and effect through December 31,
2004 (the "Term").
6. Section 13.5, RESIDUAL PAYMENTS, is hereby deleted in its entirety and
replaced with the following:
13.5 RESIDUAL PAYMENTS. The Parties acknowledge and agree that in
the Territory, through the Abbott Promotion Efforts, Abbott
has enhanced the value of and goodwill associated with the
Product, Trademarks and other property of Sepracor.
Therefore, upon execution of this Third Amendment, Sepracor
agrees to pay Abbott as follows:
13.5.1 Thirty Million and 00/100 U.S. Dollars or
$30,000,000.00 on or before December 31, 2005. The
Parties agree that one-half of this payment or $15
million, shall not be subject to any contingencies
whatsoever. The Parties agree that with respect to
the other half of this payment or $15 million, $3.75
million shall be earned and shall accrue each
quarter of calendar year 2005 in which Sepracor
achieves Pediatric Sales for the Product of at least
$[**]; and
13.5.2 Three Million and 00/100 US Dollars or $3,000,000.00
on or before December 31, 2006. The Parties agree
that one-half of this payment or $1.5 million, shall
not be subject to any contingencies whatsoever. The
Parties agree that with respect to the other half of
this payment or $1.5 million, $375,000 shall be
earned and shall accrue in each quarter of calendar
year 2006 in which Sepracor achieves Pediatric Sales
for the Product of at least $[**].
13.5.3 The contingencies established in Section 13.5.1 and
13.5.2 above shall not apply and Sepracor shall be
responsible for payment in full of the contingent
payments described above if the failure to satisfy
the contingencies results from any action or failure
to act on the part within the control of Sepracor.
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7. This Third Amendment may be executed in counterparts, each of which
shall be deemed to be an original and all of which, when taken
together, shall constitute the Third Amendment.
8. Except as expressly amended by this Third Amendment, the Agreement
shall be and remain in full force and effect in accordance with its
terms.
IN WITNESS WHEREOF, the parties hereto have caused this three (3) page Third
Amendment to be executed in duplicate by their duly authorized representatives
and entered into and effective as of the day and year first set forth above.
Sepracor Inc. ▇▇▇▇▇▇ Laboratories Inc.
By: /s/▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇'▇▇▇▇ By: /s/▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇
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▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇'▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇
President and Chief Operating Officer President, ▇▇▇▇ Products Division
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