EXHIBIT 10.53
Confidential treatment has been requested for portions of this
exhibit. The copy
filed herewith omits the information subject to the confidentiality request.
Omissions are
designated
as ***. A complete
version of this
exhibit has been
filed separately with the Securities and Exchange Commission.
DISTRIBUTION SERVICES AND STORAGE AGREEMENT
BETWEEN
CELGENE CORPORATION
AND
SHARP CORPORATION
JANUARY 1, 2005
1
*** - indicates
material omitted pursuant to a Confidential Treatment Request
and filed separately with the Securities and Exchange
Commission.
<PAGE>
DISTRIBUTION SERVICES AND STORAGE AGREEMENT
This Amended and Restated Distribution Services Agreement
entered into
this 1st day of January, 2005, by and between Celgene
Corporation,
a Delaware
corporation ("CELGENE"), and Sharp Corporation ("SHARP").
WHEREAS, CELGENE
and SHARP entered into a Distribution Services
Agreement dated June 12, 2000 (the "Agreement"); and
WHEREAS, CELGENE and SHARP desire to amend and restate the
Agreement in
its entirety.
NOW, THEREFORE, in consideration of the promises, covenants,
agreements
and other valuable
consideration
hereinafter
set forth,
the parties
hereto
hereby amend and restate the Agreement in its entirety as
follows:
Article 1.
DEFINITIONS
As used in this
agreement, the
following words and phrases shall have
the following meanings:
(a)
"FDA"
shall mean the United States Food and Drug
Administration, or any successor entity thereto.
(b) "Act"
shall mean the United
States Food, Drug and
Cosmetics Act, as amended, and rules and regulations
promulgated thereunder.
(c) "Products"
are defined in schedule 1.(c)
(d) "SHARP
facility" shall mean
SHARP's facility
either
owned or leased by
Sharp, at which
SHARP provides
distribution services for pharmaceutical products.
(e) "API"
shall mean the active pharmaceutical ingredient
required to
manufacture
a formulation of drug
product.
(f) "One Time
Costs" as defined in schedule 1.(f)
Article 2. TERM
This Agreement
shall be in effect
for an initial term of *** years
commencing January 1st, 2005 (the "Initial Term"), for the
distribution
of Celgene products,
if not earlier terminated according to Article 5
of this Agreement. The term of this Agreement shall automatically
renew
for successive
***-year periods unless either party hereto
gives the
2
*** - indicates
material omitted pursuant to a Confidential Treatment Request
and filed separately with the Securities and Exchange
Commission.
<PAGE>
other notice of
non-renewal
hereof at least ***
months prior to
the
expiration of the Initial Term or any *** year renewal period, as the
case may be.
Distribution terms of in-licensed product are subject to
the term of the individual licensing agreements.
Article 3.
ENGAGEMENT; SERVICES
3.01
CELGENE hereby engages SHARP and SHARP hereby accepts the
engagement by
CELGENE, to provide
the services
hereinafter described
on the terms,
and subject to the conditions set forth in this Agreement.
3.02
SHARP will,
as agent for CELGENE, process sales orders for the
Products, ship the
Products and process returns of the Products.
Without limiting the generality of the preceding sentence, SHARP
will
(a) dedicate
at least *** square feet at the SHARP
facility for the
warehousing of the
Products, the
processing of sales
orders for the
Products and the
processing of returns of the Products;
(b) dedicate
at least *** full-time
SHARP employees to
provide the services described herein;
(c) provide
storage space at the
SHARP facility to store
API as needed;
(d) provide
perpetual tracking of inventory of the
Products by lot number.
(e) provide
supervision
of the destruction of returned
and expired
Products; and provide reporting and
documentation of
product destruction within ten
business days of destruction of product.
(f) provide
for the refrigerated,
2-8(degrees)C
(36-46(degrees)F), storage as required.
(g)
provide office space for at least *** Celgene
employee.
3.03
CELGENE will provide SHARP remote access to CELGENE's validated sales
order processing
system, and the computer equipment to be described on
Schedule 3.03 hereto for the purpose of such access and to enable
SHARP
to report on a daily work-day basis to CELGENE. SHARP acknowledges
that
any and all information equipment, inventory or other items
provided to
SHARP pursuant
to this Agreement shall be and remain the
exclusive
property of CELGENE,
shall be used by SHARP
solely for the purpose of
rendering the services
provided for
hereunder and shall be returned
promptly by SHARP
to CELGENE upon termination of this Agreement,
without SHARP having retained any copy thereof.
Article 4.
FEES, EXPENSES
3
*** - indicates
material omitted pursuant to a Confidential Treatment Request
and filed separately with the Securities and Exchange
Commission.
<PAGE>
4.01
For all services to be rendered by SHARP to CELGENE hereunder,
CELGENE
shall pay SHARP the fees set forth on Schedule 4.01 hereto at the
times
also
described in such Schedule.
4.02
Freight charges will be billed directly to CELGENE by carriers.
4.03
Additional charges due
to volume demand,
changes required by Celgene,
and/or annual
inflation/wage
increases, to be
mutually agreed
upon.
Reductions in charges due to volume decline or other similar
factors,
are to be negotiated
in good faith and
mutually agreed upon.
If the
parties cannot agree on the price adjustments, the parties will abide
by the opinion of a mutually agreed upon arbitrator.
5.
TERMINATION
5.01
Upon the occurrence of the following events, either party may
terminate
this Agreement by giving the other party *** days prior written
notice:
(a) If the other party
is unable to pay its
debts, becomes
bankrupt or
insolvent or enters into liquidation whether
compulsory or
voluntary,
or compounds with or convenes a
meeting of its
creditors, or has a
receiver appointed overall
or part of its assets,
or takes or suffers any similar action
in consequence of a debt, or ceases for any reason to carry on
business; or
(b) Upon the breach of any material provision of this
Agreement by the other party if the breach is not cured within
*** days after written
notice thereof to the party in default
and the material
breach continues to exist at the time of
notice of termination.
5.02
CELGENE may terminate
this Agreement at any time by giving *** days
written notice to SHARP, if CELGENE, in its sole discretion,
determines
that it will no longer
market the
Products or if the FDA withdraws
approval of the
manufacture or marketing of the Products. CELGENE may
terminate this agreement if the FDA or any other regulatory agency
that
regulates the
Products takes any action the result of which is to
prohibit the
manufacture,
sale or use or any
similar action of the
Products or any raw material contained therein or to impose
significant
restriction.
5.03
The Agreement may be terminated Pursuant to Article 2, which
provides
for termination,
by notice from either
party, upon expiration
of the
Initial Term or any *** period.
5.04
Termination,
expiration, or cancellation of this Agreement through any
means and for any reason shall not relieve the parties of any
obligation accruing
prior thereto, including but not limited to
the
confidentiality
provisions herein and the obligation to pay money, and
shall be without
prejudice to the
rights and remedies of either party
with respect to the antecedent breach of any of the provisions of
this
Agreeme
