DISTRIBUTION SERVICES AND STORAGE AGREEMENT BETWEEN CELGENE CORPORATION AND SHARP CORPORATIONDistribution Agreement |
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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
th






