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.
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.
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.
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
Agreement. During the term of this Agreement and for a period of ***
years thereafter, both parties hereto, subject to applicable laws,
shall maintain in confidence all information received from the other
party resulting from or related to the matters contemplated by this
Agreement.
4
*** - indicates material omitted pursuant to a Confidential Treatment Request
and filed separately with the Securities and Exchange Commission.
5.05 If for any reason Celgene terminates contract prior to full term,
Celgene will repay Sharp's facility "one time costs" according to
schedule 5.05.
Article 6. REPRESENTATION, WARRANTY AND COVENANT
SHARP represents and warrants to, and covenants with, CELGENE that it
shall render its services hereunder in compliance with all applicable
laws and regulations, including, but not limited to, those dealing with
occupational safety and health, those dealing with public safety and
health, those dealing with protecting the environment, and those
dealing with disposal of wastes.
Article 7. INDEMNIFICATION
7.01 CELGENE shall indemnify and hold SHARP, its officers, directors,
agents, servants, and employees harmless against all claims, losses,
damages and liabilities, including reasonable legal expenses, arising
out of CELGENE'S duties under this Agreement or the use of the
products, and which are not attributable to:
(a) the negligence of SHARP or its agents or employees,
(b) the failure of SHARP to follow the written
instructions and specifications of CELGENE; or
(c) SHARP's breach of this Agreement.
SHARP shall not settle any such claim without the prior written
approval of CELGENE and CELGENE shall have the right, if it so wishes,
to conduct negotiations to settle, settle or conduct any litigation
arising out of, any such claim. SHARP shall provide prompt notice of
any claim to CELGENE and shall cooperate in the defense of the claim.
7.02 SHARP shall indemnify and hold CELGENE, its officers, directors,
agents, servants, and employees harmless against all claims, losses,
damages, and liabilities including reasonable legal expenses, arising
out of SHARP's duties under this Agreement and which are not
attributable to:
(a) any act or negligence of CELGENE or its agents or
employees,
(b) the failure of CELGENE or its employees to comply
with applicable law or regulations, or
(c) Celgene's breach of this Agreement.
CELGENE shall not settle any such claim without the prior written
approval of SHARP, and that SHARP shall have the right, if it so
wishes, to conduct negotiations to settle, settle or conduct any
litigation arising out of, any such claim. CELGENE shall provide
5
*** - indicates material omitted pursuant to a Confidential Treatment Request
and filed separately with the Securities and Exchange Commission.
prompt and written notice of any such claim to SHARP and shall
cooperate in the defense of the claim.
7.03 The indemnification obligations set forth in this Article 7 shall
survive the termination of this Agreement.
Article 8. QUALITY AGREEMENT
A Quality Agreement shall be in place by March 15, 2005 or a date
shortly after that is mutually agreed upon by both parties.
Article 9 RIGHTS TO INSPECT
9.01 In performing distribution of the Products hereunder, SHARP shall
permit CELGENE and/or its designated representative, but not a
competitor of Sharp, to inspect on a regular basis or as needed, but
not less than once per year that portion of SHARP Facility to evaluate
SHARP's work practices, supporting systems, documents and records
associated with the Products and make such copies of the documents as
reasonably necessary for the purpose of assessing SHARP's compliance
with applicable regulations. Additionally, SHARP shall from time to
time permit CELGENE and/or its designated representative access to the
SHARP Facility for the purpose of confirming inventory of the Products
on hand, as and when such confirmation is determined to be appropriate
by CELGENE's external auditors. All such reviews shall be conducted
upon reasonable prior notice by CELGENE.
9.02 SHARP shall keep CELGENE fully informed of the steps taken by SHARP to
resolve any outstanding issues with the FDA and the anticipated
timetable of resolution of such issues as it applies to either of the
Products.
Article 10 ASSIGNMENT
This Agreement may not be assigned or transferred by SHARP without the
prior written consent of CELGENE. In the event there is a change of
control of SHARP or its business, this Agreement will remain in effect
and bind the acquirer.
Article 11 COURT PROCEEDINGS; GOVERNING LAW
Any court proceeding initiated by one party against the other with
respect to any dispute under this Agreement shall be commenced in the
United States District Court for the Eastern District of New Jersey.
This Agreement will be governed by, and construed in accordance with,
the laws of the State of New Jersey.
Article 12 FORCE MAJEURE
Any delay in the performance of any of the duties or obligations of
either party (except the payment of money due hereunder) shall not be
considered a breach of this Agreement and the time required for
performance shall be extended for a period equal to the period
6
*** - indicates material omitted pursuant to a Confidential Treatment Request
and filed separately with the Securities and Exchange Commission.
of such delay; provided that such delay has been caused by or is the
result of any acts of God, acts of the public enemy, insurrections,
riots, embargoes, labor disputes, including strikes, lockouts, job
actions, or boycotts, equipment failure, fires, explosions, floods,
shortages of material or energy or other unforeseeable causes beyond
the reasonable control of the party so affected. The party so affected
shall give prompt notice to the other party of such cause, and shall
take whatever reasonable steps are necessary to relieve the effect of
such cause as rapidly as reasonably possible. Not withstanding the
forgoing, if SHARP is unable to perform for any of the above enumerated
reasons, CELGENE shall be relieved of its obligations hereunder during
the pendency thereof, and if such inability of SHARP to perform
continues for a period longer than *** days, CELGENE shall have a right
to terminate this Agreement.
Article 13. SEVERABILITY
3.04 In the event that any provision of this Agreement is judicially
determined to be void or unenforceable, such provision shall be
construed to be separable from the other provisions of this Agreement
which shall retain full force and effect.
Article 14 HEADINGS
All titles and captions in this Agreement are for convenience purposes
only and shall not be of any force or substance.
Article 15 USE OF NAMES
Except as expressly required pursuant to the Act, neither party will
without the prior written consent of the other: (a) use in advertising,
publicity, promotional premiums or otherwise, any trade name,
trademark, trade device, service xxxx, symbol, or any abbreviation,
contraction or simulation thereof owned by either party, or (b)
represent, either directly or indirectly, that any product or service
of one party is a product or service of the other.
Article 16 INDEPENDENT CONTRACTOR
3.05 Each party is acting under this Agreement as an independent contractor
and not as the agent or employee of the other. Each party understands
and agrees that it has no authority to assume any obligation on behalf
of the other party and that it shall not hold out to third parties that
it has any authority to act on the other party's behalf except as
expressly permitted herein. Unless otherwise expressly stated herein,
each party shall be responsible for its own expenses relating to its
performance under this Agreement and shall not incur expenses for the
other party's account unless expressly authorized herein or by
subsequent written agreements.
Article 17 WAIVER
No waiver or modification of any of the terms of this Agreement shall
be valid unless in writing and signed by an authorized representative
of both parties hereto. Failure by
7
*** - indicates material omitted pursuant to a Confidential Treatment Request
and filed separately with the Securities and Exchange Commission.
either party to enforce any rights under this Agreement shall not be
construed as a waiver of such rights nor shall a waiver by either party
in one or more instances be construed as constituting a continuing
waiver or as a waiver in other instances.
Article 18 PUBLIC DISCLOSURE
Neither party shall disclose to any third party or originate any
publicity, news release or public announcement, written or oral,
whether to the public or the press, or otherwise, refer into the terms
of this Agreement, including its existence, the subject matter to which
it relates, the performance under it or any of its specific terms and
conditions, except by such announcements as are (i) mutually agreed
upon by the parties in writing, or (ii) in the opinion of counsel for
the party making such announcement are required by law. If a party
believes a public announcement to be required by law with respect to
this Agreement, it will give the other party such notice as is
reasonably practicable and an opportunity to comment upon the
announcement.
ARTICLE 19 NOTICES
Unless otherwise specified herein, all notices required or permitted to
be given under this Agreement shall be in writing and shall be
delivered either personally and promptly confirmed by such registered
or certified mail or overnight courier service or sent by registered or
certified mail, return receipt requested, or by overnight courier
service, postage prepaid in each case, or by facsimile and promptly
confirmed by such registered certified mail or overnight courier
service to the receiving party at such party's address set forth below,
or at such other address as may from time to time be furnished by
similar notice by either party. Any notice sent by registered or
certified mail as aforesaid shall be deemed to have been given when
mailed, and shall be effective upon receipt.
If to SHARP:
Sharp Corporation
0000 Xxxxxxx Xxx
Xxxxxxxxx, Xxxxxxxxxxxx 00000
Attention:_Chief Financial Officer
If to CELGENE:
Celgene Corporation
00 Xxxxxx Xxxxxx
Xxxxxx, Xxx Xxxxxx 00000 X.X.X.
Attention: Vice President, Legal and Chief Counsel
or to such other address as the addressee shall have last furnished in
writing to the addresser.
8
*** - indicates material omitted pursuant to a Confidential Treatment Request
and filed separately with the Securities and Exchange Commission.
ARTICLE 20. ENTIRE AGREEMENT
20.01 This Agreement constitutes the entire agreement between the parties
with respect to the subject matter hereof, and supersedes all written
or oral agreements or understandings with respect thereto.
20.02 Neither party shall claim any amendment, modification, or release from
any provision, hereof, unless such an amendment is in writing signed by
an authorized representative of each party.
SHARP CORPORATION CELGENE CORPORATION
By:*** By:***
Name:*** Name:***
Title:*** Title:***
Date: 4/11/05 Date: April 13, 2005
9
*** - indicates material omitted pursuant to a Confidential Treatment Request
and filed separately with the Securities and Exchange Commission.
