Distribution Services Agreement - Celgene Corp. and Ivers Lee Corp. d/b/a Sharp
DISTRIBUTION SERVICES AGREEMENT
BETWEEN
CELGENE CORPORATION
AND
IVERS LEE CORPORATION
JUNE ___, 2000
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DISTRIBUTION SERVICES AGREEMENT
This Agreement entered into this ___ day of ___ 2000_, by and between
Celgene Corporation, a Delaware corporation ("CELGENE"), and Ivers Lee
Corporation, a Delaware corporation doing business as "Sharp" ("SHARP").
WHEREAS, CELGENE manufactures, markets and distributes the
pharmaceutical product ThalomidTM (the "Product"); and
WHEREAS, SHARP is in the business of providing distribution services
for pharmaceutical products at its facility in West Caldwell, New Jersey (the
"SHARP Facility"); and
WHEREAS, CELGENE desires to engage SHARP to provide distribution
services with respect to the Product, and SHARP desires to be engaged to provide
such services.
NOW, THEREFORE, in consideration of the promises, covenants, agreements
and other valuable consideration hereinafter set forth, the parties hereto
hereby agree 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.
ARTICLE 2. TERM
This Agreement shall be in effect for an initial term of three (3) years (the
"Initial Term"), if not earlier terminated according to Article 5 of this
Agreement. The term of this Agreement shall automatically renew for successive
one-year periods unless either party hereto gives the other notice of
non-renewal hereof at least six months prior to the expiration of the Initial
Term or any one-year renewal period, as the case may be.
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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 Product sales orders, ship
Product and process Product returns. Without limiting the generality of
the preceding sentence, SHARP will
(a) dedicate at least 2,000 square feet at the SHARP Facility for the
warehousing of Product, the processing of sales orders for Product and
the processing of Product returns;
(b) dedicate at least five full-time SHARP employees to provide the
services described herein;
(c) provide storage space at the SHARP Facility for 38 pallet
positions;
(d) provide perpetual tracking of Product inventory by lot number
within SHARP's inventory system; and
(e) provide supervision of the destruction of returned and expired
Product.
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
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.
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ARTICLE 5. TERMINATION
5.01 Upon the occurrence of the following events, either party may terminate
this Agreement by giving the other party sixty (60) 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 thirty (30) 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 (a) CELGENE may terminate this Agreement at any time by giving sixty
(60) days written notice to SHARP, if CELGENE, in its sole discretion,
determines that it will no longer market Thalomid or if the FDA
withdraws approval of the manufacture or marketing of Thalomid. CELGENE
may terminate this agreement if the FDA or any other regulatory agency
that regulates Thalomid takes any action the result of which is to
prohibit the manufacture, sale or use or any similar action of the drug
product 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 one-year renewal 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 five
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.
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.
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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, and which are not
attributable to:
(i) the negligence of SHARP or its agents or employees,
(ii) the failure of SHARP to follow the written
instructions and specifications of CELGENE; or
(iii) 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:
(i) any act or negligence of CELGENE or its agents or
employees,
(ii) the failure of CELGENE or its employees to comply
with applicable law or regulations, or
(iii) 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 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 11 shall
survive the termination of this Agreement.
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ARTICLE 8. GOVERNMENT INSPECTION
8.01 SHARP will notify CELGENE within twenty-four (24) hours of notification
of any pending or ongoing FDA or government inspection related to
Thalomid. SHARP shall immediately provide copies of any Form 483
warning letter observations, or associated correspondence to and
received from the FDA within two (2) work-days of receipt and in
addition shall provide a facsimile copy within twenty-four (24) hours
to CELGENE
SHARP shall allow CELGENE to assist in any response to the FDA,
including review of any written response made to the FDA by SHARP at
CELGENE'S discretion.
ARTICLE 9. RIGHTS TO INSPECT
9.01 In performing distribution of Thalomid hereunder, SHARP shall permit
CELGENE and/or its designated representative 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 Thalomid 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 Product inventory 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 Thalomid.
ARTICLE 10. ASSIGNMENT
10.01 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 acquiror.
ARTICLE 11. COURT PROCEEDINGS; GOVERNING LAW
11.01 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.
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ARTICLE 12. FORCE MAJEURE
12.01 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 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 and without the fault or negligence 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 one week, CELGENE shall
have a right to terminate this Agreement.
ARTICLE 13. SEVERABILITY
13.01 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
14.01 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
15.01 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 mark, 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
16.01 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
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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
17.01 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 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
18.01 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, referring to 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
19.01 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.
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IF TO SHARP:
Ivers Lee Corporation
147 Clinton Road
West Caldwell, New Jersey 07006
Attention:
IF TO CELGENE:
Celgene Corporation
7 Powder Horn Drive
Warren, New Jersey 07059 U.S.A.
Attention:
or to such other address as the addressee shall have last furnished in writing
to the addresser.
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.
IVERS LEE CORPORATION CELGENE CORPORATION
By:__________________________ By:________________________
Name: Name:
Title: Title:
Date: Date: