Exhibit 10.11
***Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and
230.406
Agreement
among
SCHERING Aktiengesellschaft
Müllerstra b e 178
13342 Berlin
(hereinafter called
“SCHERING”)
and
NeuroBiotec GmbH
Tegeler Strai b e 6
13353 Berlin
(hereinafter called
“NEUROBIOTEC”)
and
Prestwick Pharmaceuticals, Inc.
1825 K Street
Washington, D.C. 2006
(hereinafter called “PRESTWICK”)
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RECITALS
Whereas
SCHERING and NEUROBIOTEC have
entered into a Technology Transfer Agreement as amended as of
May 30, 2002 (the “ Technology Transfer Agreement
”) concerning the sale and transfer of patents and know-how
relating to the development, production and marketing of (1) a
ready to use pharmaceutical speciality for trans-dermal use (the
“ Patch Product ”) and (2) all other non
per-oral ready to use pharmaceutical specialties for sustained
release (collectively the “ Other Sustained Release
Products ”) in humans containing Lisuride and/or Lisuride
hydrogen maleate and/or all other pharmaceutically active salts and
esters of Lisuride (the “ Product(s) ”) from
SCHERING to NEUROBIOTEC;
Whereas
NEUROBIOTEC has identified
PRESTWICK as partner for the development and marketing in the
United States of America (the “ U.S. ”) and
Canada of the Patch Product (the “ U.S./Canada Patch
Product ”) and the Other Sustained Release Products (the
“ U.S./Canada Other Sustained Release Products ”
— collectively with the U.S./Canada Patch Product, the
“ U.S./Canada Products ”) and has negotiated
with PRESTWICK an exclusive, sublicensable license-, development,
commercialisation- and drug supply agreement relating to the
development and sale of the U.S./Canada Products (the “
Prestwick Cooperation ”);
Whereas
SCHERING under the Technology
Transfer Agreement has an option to obtain exclusive,
sub-licensable development, production and marketing rights for the
“U.S./Canada Patch Product” (the “ U.S./Canada
Option ”), and a right of first refusal to take an
exclusive, sub-licensable license to develop, produce and market
the “U.S./Canada Other Sustained Release Products” (the
“ U.S./Canada Right of First Refusal
”);
Whereas
PRESTWICK wishes to take over the
development and marketing of the U.S./Canada Patch Product without
being restricted by SCHERING’s U.S./Canada Option, and the
development and marketing of the U.S./Canada Other Sustained
Release Products without being restricted by SCHERING’s
U.S./Canada Right of First Refusal;
Whereas
SCHERING is prepared to waive its
U.S./Canada Option and its U.S./Canada Right of First Refusal under
the conditions set forth in this Agreement in order to allow
NEUROBIOTEC to grant all rights to the U.S./Canada Products to
PRESTWICK;
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Whereas
the parties agree that this
Agreement shall be conditional on the execution of the Prestwick
Cooperation;
Whereas
the parties have already entered
into an agreement concerning the development and marketing of the
Products by Prestwick for the U.S. in August/September, 2003 (the
“U.S. Agreement”);
Whereas
the parties agree that this
Agreement shall replace the U.S. Agreement;
Whereas
the parties agree that the
Prestwick Cooperation is likely to improve considerably the
prospects for a timely introduction of the U.S./Canada Products and
that the simultaneous and coordinated development activities in
Europe and the U.S. and Canada are intended to result in
development cost reductions and to generate other synergies for the
parties hereof.
The parties, therefore, hereby
agree to and amend the Technology Transfer Agreement as
follows:
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1.
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Definitions
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“Affiliate”
has the meaning set
forth in Article 1 of the Technology Transfer
Agreement.
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“Agreement”
means this
three-party-agreement by and among SCHERING, NEUROBIOTEC and
PRESTWICK.
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“Business
Day” means a day which is not a Saturday,
a Sunday or other day on which banks are required or authorized by
law to be closed in Washington D.C., U.S., or Berlin,
Germany.
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“Confidential
Information” has the meaning set forth in
Section 8.1.
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“Development
Cost” has the meaning set forth in
Article 1 of the Technology Transfer Agreement.
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“Existing Schering
Data” has the meaning set forth for the
term “Data” in Article 1 of the Technology
Transfer Agreement.
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“First Commercial
Sale” means the date on which the first
Product is sold commercially by PRESTWICK or on PRESTWICK’s
behalf by any sublicensee of PRESTWICK in the U.S. or
Canada.
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“Know-how”
means: techniques, data
and information relating to the Products, including, but not
limited to, inventions, practices, methods, manufacturing
processes, knowledge, know-how, skill, trade secrets, experience,
test data (including pharmacological, toxicological, pre-clinical
and clinical test data); data, records and information derived from
pre-clinical development, clinical development or CMC/process
development, regulatory submissions, adverse reactions, analytical
and quality control data, marketing, pricing, distribution, cost,
sales and manufacturing data or descriptions.
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“Net Sales”
means the amount
invoiced by PRESTWICK or any sublicensee of PRESTWICK (each a
“Seller”) for sales of a Product to unaffiliated third
parties less the following deductions applicable to the Products
for:
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(i)
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transportation charges and insurance
charges paid by the Seller;
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(ii)
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sales and excise taxes or customs
duties paid by the Seller or any other governmental charges imposed
upon the sale of the Products and paid by the Seller;
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(iii)
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rebates and premiums granted or
allowed in connection with the sale of a Product;
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(iv)
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allowances or credits to customers
on account of governmental requirements, price differences,
rejection, outdating, returns or recalls of the
Products;
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(v)
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quantity discounts, cash discounts
or chargebacks granted in connection with the sale of the
Products,
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(vi)
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provisions for price
reductions.
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In
the event a Product is sold in the form of a combination product
containing one or more active ingredients in addition to a Product,
Net Sales for such combination product will be adjusted by
multiplying actual Net Sales of such combination product by the
fraction A / (A+B) where A is the invoice price of the Product, if
sold separately, and B is the invoice price of any other
active
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ingredient or ingredients in the
combination, if sold separately. If the other active ingredient or
ingredients in the combination are not sold separately, Net Sales
shall be calculated by multiplying actual Net Sales of such
combination product by the fraction A / C where A is the invoice
price of the Product if sold separately, and C is the invoice price
of the combination product. If neither the Product nor the other
active component or components of the combination product is sold
separately, Net Sales shall be determined between SCHERING and
PRESTWICK in good faith.
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“Other Sustained Release
Products” has the meaning set forth in the
first paragraph of the Recitals above.
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“Patch
Product” has the meaning set forth in the
first paragraph of the Recitals above.
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“Prestwick
Cooperation” has the meaning set forth in the
second paragraph of the Recitals above.
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“Product(s)”
has the meaning set
forth in the first paragraph of the Recitals above.
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“Step I
Milestone” means the fee to be paid by SCHERING
to NEUROBIOTEC pursuant to Section 7.1 (ii) of the Technology
Transfer Agreement in order to retain its option right pursuant to
Section 7.2 of the Technology Transfer Agreement.
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“Technology Transfer
Agreement” has the meaning set forth in the
first paragraph of the Recitals above.
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“U.S.”
has the meaning set
forth in the second paragraph of the Recitals above.
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“U.S.
Agreement” has the meaning as set forth in the
seventh paragraph of the Recitals above;
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“U.S./Canada
Option” has the meaning as set forth in the
third paragraph of the Recitals above.
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“U.S./Canada Other Sustained
Release Product” has the meaning set forth in the
second paragraph of the Recitals above.
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“U.S./Canada Patch
Product” has the meaning set forth in the
second paragraph of the Recitals above.
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“U.S./Canada
Products” has the meaning set forth in the
second paragraph of the Recitals) above.
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“U.S./Canada Right of First
Refusal” has the meaning set forth in the
third paragraph of the Recitals above.
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2.
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Waiver of Rights
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In
consideration of the payment of royalties to SCHERING by PRESTWICK
pursuant to Section 3 below and the reduction of the Step I
Milestone pursuant to Section 4 below, SCHERING hereby waives
its U.S./Canada Option and its U.S./Canada Right of First Refusal
vis-à-vis NEUROBIOTEC in favour of PRESTWICK in order to allow
NEUROBIOTEC to grant all rights to the U.S./Canada Products to
PRESTWICK under the Prestwick Cooperation, and Schering hereby
agrees that the execution of the Prestwick Cooperation will not
contravene, and shall be permitted under, the Technology Transfer
Agreement. Accordingly, Articles 6, 7 and 10 of the Technology
Transfer Agreement shall not apply to the U.S./Canada Products. The
scope of application of Articles 6, 7 and 10 of the Technology
Transfer Agreement is thus reduced to the development, production
and marketing of Products outside the U.S. and Canada and/or any
Product other than the U.S./Canada Products in the U.S. or
Canada.
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3.
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Royalties
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3.1
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In
consideration of the waiver by SCHERING of its U.S./Canada Option
and its U.S./Canada Right of First Refusal in PRESTWICK’s
favour pursuant to Section 2 above, PRESTWICK shall pay to
SCHERING royalties based on Net Sales of Products in the amount
of
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-
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[...***...] % for the Patch Product; and
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-
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[...***...] % for Other Sustained Release
Products.
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* Confidential
Treatment Requested
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7
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The
Parties will meet and discuss in good faith if the marketing of the
Products by PRESTWICK becomes economically unviable because of
significant generic competition to the U.S./Canada Patch Product
marketed by PRESTWICK.
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3.2
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All
royalties shall be calculated on a Product by Product basis and
shall be payable on a country-by-country basis from the date of the
First Commercial Sale of a Product in the U.S. until ten
(10)&
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