Custom Manufacturing Agreement - Johnson Matthey Inc. and Celgene Corp.
CUSTOM MANUFACTURING AGREEMENT
This Custom Manufacturing Agreement (this "Agreement") is entered into between
Johnson Matthey Inc., having an office at 2003 Nolte Drive, West Deptford, NJ
08066 ("JMI"), and Celgene Corporation, having an office at 7 Powder Horn Drive,
Warren, New Jersey 07059 ("Celgene"), to establish terms and conditions upon
which JMI will manufacture for and sell to Celgene d-methylphenidate
hydrochloride in bulk, non-sterile form ("Material"). This Agreement may be
referenced in orders and other correspondence related hereto as Agreement No.
384.
1. DEFINITIONS
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1.1 The "Effective Date" of this Agreement is June 1, 2000.
1.2 "cGMP" means those current practices, as amended from time to time,
related to the manufacture of pharmaceutical active ingredients and
their precursors laid down in guidelines and regulations such as the
United States Code of Federal Regulations (Title 21, Parts 210-211),
and the Guide to Inspection of Bulk Pharmaceutical Chemicals (U.S.
Department of Health and Human Services, Revised September 1991).
1.3 "DEA" means the United States Drug Enforcement Administration
1.4 "Defective Material" means Material that does not conform to the
warranties provided by JMI pursuant to Sections 7.1 and 7.2
hereunder, as determined in accordance with this Agreement.
1.5 "FDA" means the United States Federal Food and Drug Administration.
1.6 "Manufacturing Procedure" means Celgene's description of the
synthesis of Material as provided by Celgene to JMI, attached
hereto and incorporated herein as Exhibit A.
1.7 "NDA" means Celgene's New Drug Application to the FDA for formulated
Material.
1.8 "Pilot Phase" means the period of time commencing upon the execution
of this Agreement and continuing until the delivery of the Pilot
Phase Material.
1.9 "Pilot Phase Material" means d-methylphenidate hydrochloride in
bulk, non-sterile form manufactured by JMI and supplied to Celgene
during the Pilot Phase.
1.10 "Raw Material Specifications" means Celgene's specifications for
Resolving Agent as provided by Celgene to JMI, attached hereto and
incorporated herein as Exhibit E.
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1.11 "Resolving Agent" means dibenzoyl-D-tartaric acid that meets the Raw
Material Specifications.
1.12 "Specifications" means Celgene's specifications for Material and the
validated analytical methods for the testing and release of
Material, all as provided by Celgene to JMI, attached hereto and
incorporated herein as Exhibit B.
1.13 "Validation Phase Material" means d-methylphenidate hydrochloride in
bulk, non-sterile form manufactured by JMI and supplied to Celgene
during the Validation Phase.
1.14 "Validation Phase" means the period of time commencing upon the
conclusion of the Pilot Phase and continuing until the completion of
the regulatory filing described in Section 4.5.
2. TERM AND EXCLUSIVITY
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2.1 Term
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This Agreement shall commence on the Effective Date and shall expire
on March 31, 2006; provided, however, that this Agreement shall
terminate on June 10, 2005, in the event that Celgene is no longer
supplying product using d-methylphenidate hydrochloride to Novartis
Pharmaceuticals Corporation, or its affiliates, licensees,
successors or assigns ("NPC"), beyond such earlier termination date.
2.2 Exclusivity
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During the term of this Agreement, Celgene agrees to buy from JMI
Material in quantities that shall equal at least fifty percent (50%)
of Celgene's requirements for all formulations of Material from any
bulk manufacturer thereof in each calendar year, including NPC;
provided, however, that during calendar years 2001 and 2002, Celgene
agrees to buy from JMI all of Celgene's requirements for all
formulations of Material. During the terms of this Agreement, JMI
agrees not to sell d-methylphenidate hydrochloride to any party
other than Celgene; provided, however, that JMI shall not be
prevented from selling the racemic mixture of methylphenidate
hydrochloride to any third parties.
3. DEVELOPMENT WORK
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3.1 Price for Development Services
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The parties hereto acknowledge and agree that process development,
scale-up and validation work must be accomplished prior to the
commencement of the purchase and supply obligations identified in
Article 6. Celgene has paid to JMI, upon the delivery by JMI to
Celgene of the first lot of Pilot Phase Material pursuant to Section
3.3, in addition to the prices for Material specified in Sections
3.2 and 4.1, $300,000 for the foregoing services performed by JMI.
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3.2 Price for Pilot Material
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The price for Pilot Phase Material is $8.00 per gram.
3.3 Development Laboratory Lot
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The first lot of Pilot Phase Material has been manufactured in JMI's
development laboratory and was supplied to Celgene on June 20, 2000.
This lot provided gram quantities in an amount sufficient for
qualification testing in accordance with the Specifications.
3.4 Pilot Lots
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In addition to the lot manufactured pursuant to Section 3.3, JMI
manufactured and on July 31, 2000, supplied to Celgene two lots of
Pilot Phase Material in JMI's plant. Both lots together consisted of
approximately forty (40) kilograms total of Pilot Phase Material.
3.5 Manufacturing Conditions and Use
--------------------------------
Each of the two (2) lots of Pilot Phase Material supplied pursuant
to Section 3.4 were manufactured under non-validated cGMP
conditions. JMI supplied the Pilot Phase Material to Celgene for
evaluation and regulatory filing purposes only and Celgene covenants
that such Pilot Phase Material shall not be used for human
consumption. All Pilot Phase Material is supplied without express or
implied warranties. Full Material testing identified in the
Specifications has been performed by Celgene on the Pilot Phase
Material.
3.6 Delivery
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Samples of Pilot Phase Material were supplied by JMI to Celgene on
or about July 30, 2000.
4. VALIDATION PHASE
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4.1 Price for Validation Phase Material
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The price for all Validation Phase Material is $8.00 per gram.
4.2 Validation Loss
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JMI manufactured three (3) lots of Validation Phase Material
consisting of approximately sixty (60) kilograms each.
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4.3 Manufacturing Conditions and Use
--------------------------------
The Validation Phase Material was manufactured by JMI in conformance
with cGMPs and in accordance with the synthetic route outlined in
Exhibit A and tested to the Specifications specified in Exhibit B.
JMI supplied the Validation Phase Material to Celgene for purposes
of completing the process validation for Material.
4.4 Delivery
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All Validation Phase Material was supplied by JMI to Celgene on
December 14, 2000.
4.5 Regulatory Filing
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JMI shall file a Drug Master File and provide Celgene with a
reference letter for Material upon completion of the Validation
Phase Material and three (3) months of stability testing.
4.6 Testing
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The parties hereto acknowledge and agree that JMI will qualify
analytical methods as provided by Celgene and perform the tests
specified for Material in Exhibit B.
5. RESOLVING AGENT SUPPLY
----------------------
5.1 Celgene will provide all Resolving Agent needed by JMI to
manufacture the Pilot Phase Material, Validation Phase Material and
Material at no cost to JMI.
5.2 Celgene shall ensure that all Resolving Agent delivered to JMI shall
include instructions on proper handling requirements, including a
Material Safety Data Sheet, and shall be packaged, labeled and
transported in accordance with all applicable rules, regulations,
tariffs, ordinances and statutes.
5.3 Celgene warrants that the Resolving Agent supplied hereunder to JMI
is suitable for use in manufacturing Material pursuant to the
Manufacturing Procedure to meet the Specifications and shall conform
to the Raw Material Specifications as described in Exhibit E
attached hereto and incorporated herein, as such specifications may
from time-to-time be amended by mutual written agreement or by
requirement of the FDA or other governmental body.
6. COMMERCIAL PHASE
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6.1 The price of the commercial batches of Material is specified on
Exhibit C attached hereto and incorporated herein.
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6.2 Celgene shall provide a firm written order for Material
approximately three (3) months prior to the date of the anticipated
FDA approval of Celgene's NDA and shall also provide to JMI a
written forecast of its requirements for Material for the next
succeeding nine (9) months. Every three (3) months thereafter for
the term of the Agreement, Celgene shall provide JMI with a firm
order for the next three (3) months and a revised nine (9) month
forecast; JMI shall be entitled to rely upon the first three (3)
months of such nine (9) month rolling forecast for purposes of
obtaining the raw materials from its suppliers (other than Celgene)
for Material. JMI agrees to process and deliver quantities ordered
by Celgene within three (3) months of the date of receipt of
Celgene's firm order; provided that Celgene shall supply, free of
charge, Resolving Agent to JMI in sufficient quantities for JMI to
fill such purchase order, at least four (4) months in advance of the
anticipated delivery date for such ordered Material. Forecasts or
firm orders shall be revised in writing by Celgene should the
quantity of a forecast or firm order change exceed ten percent (10%)
of Celgene's most recent projections. JMI shall use reasonable
efforts to process and deliver quantities called for in the revised
forecasts, and Article 11 hereof shall apply to production of such
quantities. For example, if Celgene anticipates FDA approval in
April of 2001, Celgene shall provide in December, 2000 a firm order
for Material for April, May and June for 2001 and a forecast for
Material requirements for July, 2001 through March, 2002. Celgene
shall take delivery of such firm order Material for the firm order
period. If the forecasted requirements change exceeds ten (10)
percent of the forecasted quantities for any month between July,
2001 and March, 2002, a new forecast shall be provided to JMI. In
March 2001, Celgene shall provide a firm order for Material for July
through September, 2001 and a revised forecast for the months
October, 2001 through June, 2002. Material for firm orders for this
period shall agree within ten (10) percent of the previous forecast
as provided for in this section.
6.3 Material shall be shipped FOB JMI's plant in such containers as may
be agreed upon by the parties, packed in accordance with Department
of Transportation and DEA requirements for interstate shipment.
6.4 A ten percent (10%) over-run or under-run based on the quantity
indicated on Celgene's purchase order is allowed so long as DEA
manufacturing or procurement quotas for Material are not exceeded.
7. LIMITED WARRANTY AND LIABILITY
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7.1 Material shall conform to the Specifications, as the Specifications
may from time-to-time be amended by mutual written agreement or by
requirement of the FDA, other governmental body or the then current
edition of the U.S. Pharmacopeia; and JMI's production of Material
shall conform to all applicable regulations of the FDA, and other
cognizant governmental bodies as required; provided, however, that
JMI shall not be responsible for adulteration of Material or
Defective Material to the extent that such adulteration or Defective
Material is due to a faulty Manufacturing Procedure or raw materials
specified by Celgene. In the event that the Specifications are
changed in a manner that results in increased
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costs to JMI the parties shall negotiate in good faith a price
increase that is commensurate with the cost increase.
7.2 JMI warrants and guarantees that, as of the date of each shipment
hereunder of any articles subject to the provisions of the Federal
Food, Drug and Cosmetic Act (the "Act"), such article is not, when
shipped from JMI's West Deptford, New Jersey plant, adulterated or
misbranded within the meaning of the Act or of any applicable state
law in which the definitions of adulteration and misbranding are
substantially the same as those contained in the Act, or an article
which may not, under the provisions of Sections 404, 505, or 512 of
the Act, be introduced into interstate commerce. EXCEPT FOR SECTION
7.1 HEREOF AND THE PRECEDING SENTENCE, JMI MAKES NO REPRESENTATION
OR WARRANTY OF ANY KIND, EXPRESSED OR IMPLIED, INCLUDING, WITHOUT
LIMITATION, ANY AS TO MERCHANTABILITY, FITNESS FOR PARTICULAR
PURPOSE, OR ANY OTHER MATTER WITH RESPECT TO THE MATERIAL WHETHER
USED ALONE OR IN COMBINATION WITH OTHER SUBSTANCES.
7.3 JMI will provide Celgene with the results of all assays required to
be run under the Specifications. JMI will ship Material to Celgene
in accordance with Articles 6 and 11. Material will be deemed
accepted by Celgene upon final release by Celgene's Quality
Assurance Department, but in no event later than sixty (60) days
after receipt of the Material sold hereunder; provided, however, in
the case of Material having latent defects resulting in a recall of
products incorporating such Material, which upon diligent
examination in accordance with the quality control testing
procedures set out in the Specifications upon receipt could not have
been discovered during such period, Celgene shall have the right to
revoke its acceptance of such Material no later than at the time
Celgene first becomes aware of the latent defect causing such
Material to be Defective Material. Celgene, after becoming aware of
such, shall promptly notify JMI in writing if the Material is
Defective Material or is subject to any claim of damage in shipment
or shortage. In the event the Material is Defective Material, or is
subject to any claim of damage in shipment or shortage, the rejected
Material shall not be used by Celgene and the entire shipment shall
promptly be returned by Celgene to JMI at JMI's expense, or such
other mutually agreed upon response shall be undertaken. JMI shall
have the right, but not the obligation, to re-test the rejected
Material in accordance with Exhibit B. In the event that JMI
disputes Celgene's determination that Material is Defective Material
or has been damaged or is subject to a shortage in quantity, the
parties shall meet to resolve, in good faith, such dispute. In the
event that JMI disputes Celgene's determination of Defective
Material and the parties are unable to resolve such dispute, the
parties shall promptly name an independent and mutually acceptable
laboratory (the "Laboratory") that has been qualified for the
appropriate testing method(s). The Laboratory shall test the
Material in accordance with the Specifications, and such test
results obtained by the Laboratory shall be final and controlling.
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7.4 Upon return of any rejected Material, and JMI's agreement, or a
final determination in accordance with this Agreement, that such
Material is Defective Material or has been damaged, JMI will replace
the Material at JMI's cost and will resubmit to Celgene within sixty
(60) days of receipt of additional raw materials from Celgene and
JMI's other suppliers. CELGENE'S EXCLUSIVE REMEDY FOR BREACH OF
WARRANTY SHALL BE RECOVERY OF DIRECT DAMAGES AND, EXCEPT TO THE
EXTENT PROVIDED IN SECTION 7.7, JMI's LIABILITY FOR ANY AND ALL
LOSSES OR DAMAGE FROM ANY CAUSE WHATSOEVER, INCLUDING WITHOUT
LIMITATION, ALLEGED NEGLIGENCE, SHALL IN NO EVENT EXCEED THIS
OBLIGATION TO REPLACE THE MATERIAL AND RESUBMIT IT TO CELGENE WITHIN
THE TIME PERIOD STATED. In the event that JMI fails to replace the
Material or fails to do so within the time period stated, Celgene
shall have the right to demand a credit of the purchase price
therefor. Subject to Section 7.7, JMI shall not be liable for, and
Celgene assumes responsibility for, all injuries or damages to any
person or property resulting from the handling, possession, or use
of the Material following Celgene's receipt of the Material.
7.5 IN NO EVENT SHALL JMI BE LIABLE FOR SPECIAL, INCIDENTAL OR
CONSEQUENTIAL DAMAGES, WHETHER CELGENE'S CLAIM FOR BREACH OF
WARRANTY IS IN CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE;
PROVIDED, HOWEVER, THAT THE FOREGOING SHALL NOT IN ANY RESPECT
WHATSOEVER LIMIT JMI'S LIABILITY UNDER SECTION 7.7. Except to the
extent otherwise provided under Section 7.7, Celgene agrees to
indemnify and hold harmless JMI from all losses, liability, damages,
and/or expenses which may be sustained or claimed against JMI
arising out of the handling, possession, or use of the Material,
following Celgene's receipt of the Material.
7.6 Celgene assumes and will bear the expenses of, and will hold JMI
harmless against, any loss, suit, claim or damage arising from or
out of any intellectual property liability for Material manufactured
to Celgene's Specifications or by the Manufacturing Procedure
provided by Celgene, including, without limitation, for actual or
alleged infringement of any U.S. or foreign patents because of use
of Material or such Manufacturing Procedure, including, without
limitation, manufacturing Material with and use of Resolving Agent.
JMI agrees to promptly notify Celgene in writing of all claims and
threatened claims against JMI for which JMI may be entitled to
indemnity hereunder. Celgene shall have the right to defend and/or
settle any such claim and JMI shall give Celgene such information
and assistance as may be reasonably necessary in the conduct of such
defense. JMI shall have the right to participate in such defense at
its cost.
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7.7 JMI assumes and will bear the expense of, and will hold Celgene
harmless against, any loss, suit, claim, or damage asserted by a
third party resulting from or out of Defective Material; provided
that in no event shall JMI's liability in connection with its
performance under this Agreement, regardless of the basis of the
claim, exceed twenty million dollars ($20,000,000) in the aggregate.
7.8 Celgene agrees to promptly notify JMI in writing of all claims and
threatened claims against Celgene for which Celgene may be entitled
to indemnity hereunder. JMI shall have the right to defend and/or
settle any such claim and Celgene shall give JMI such information
and assistance as may be reasonably necessary in the conduct of such
defense. Celgene shall have a right to participate in such defense
at its cost.
8. FORCE MAJEURE
--------------
8.1 Original agreed upon times are not to be deemed of the essence of an
accepted order and reasonable variations from originally agreed upon
times will be accepted by Celgene. JMI's obligations to process and
Celgene's obligations to take, Material shall be subject to any
delays caused by acts of God, fires, floods, explosion, sabotage,
riot, accidents; orders of, or failure to issue or continue in
effect all necessary permits by, civil or military authorities
whether relating to manufacture and sale of the Material, or
discharge of materials into the environment or otherwise; delays by
suppliers of fuel, power, raw materials (including Resolving Agent),
containers or transportation; breakage or failure of machines,
strikes, lockouts or labor trouble; perils of the sea; or any other
cause beyond such party's reasonable control; provided that no event
of force majeure shall excuse Celgene from taking and paying for
Material that JMI has made or that is in the process of being made
and is subject to a firm order therefor.
8.2 The party invoking this Article 8 shall give the other party prompt
written notice of any event that is likely to delay shipment or
acceptance. No such delay shall result in cancellation of quantities
required hereunder, or of this Agreement, provided that either party
may cancel or amend the quantities delayed wihout penalty if any
delay lasts longer than ninety (90) days.
8.3 If for any reason JMI is unable or unwilling to supply such quantity
and/or quality of Material to Celgene as contemplated hereunder,
Celgene shall have the right to qualify an alternate source of
Material and purchase such quantity of Material from such source,
without further obligation to JMI hereunder with respect to such
Material that JMI does not supply; provided, however, that upon
written notice by JMI that JMI is able to resume the supply of
Material, Celgene shall resume its purchasing from JMI; provided
further, however, that Celgene may not invoke the provisions of this
Article 8 due to its inability to supply Resolving Agent to JMI if
Celgene is able to supply Resolving Agent to any third party.
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9. GROSS INEQUITIES
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9.1 It is the further intent of the parties hereto that they shall
mutually benefit from the terms, conditions and provisions of this
Agreement, and in the event that either party shall suffer a gross
inequity resulting from such terms, conditions or provisions, or
from a substantial change in circumstances or conditions, the
parties shall negotiate in good faith to resolve or remove such
inequity. It is mutually understood and agreed, however, that
nothing herein shall be construed to relieve either party of any of
its obligations under this Agreement, unless and until such changes
have been agreed to in writing by both parties.
10. PAYMENT
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10.1 Celgene will remit payment in U.S. dollars within thirty (30) days
from the date of the invoice. Celgene agrees to pay an interest
charge equal to one and one-half percent (1.5%) per month on the
unpaid balance on any invoice.
10.2 Price Charges - The price of Material shall be automatically subject
to price escalation on the first day of each calendar year beginning
with January 1, 2002, by a percentage equal to the percentage change
in the producer price index ("PPI"). The PPI referenced herein shall
be determined from Table VI of the Producer Prices and Price Index,
commodity code 063 for drugs and pharmaceuticals, Bureau of Labor
Statistics (or if discontinued such equivalent index as is mutually
agreed to by the parties). The percentage change in the PPI shall be
determined by dividing the final annual average PPI for the
immediately preceding calendar year by the final annual average PPI
for the next preceding calendar year. For example, the price
increase effective January 1, in year X would be determined under
the above formula by dividing the final annual average from calendar
year X-1 by the final annual average PPI from calendar year X-2. If
such percentage change is less than zero percent (0.00%), the prices
shall remain unchanged.
10.3 Any present or future duty, sales, use, excise or other taxes other
than taxes on income, whether Federal, State or local, applicable to
this transaction are not included in the price herein stated and
when due shall be paid by Celgene without cost or charge to JMI.
11. DEA AND HAZARDS REQUIREMENTS
----------------------------
11.1 The Material is scheduled under the Federal Controlled Substances
Act. JMI is required to obtain a quota from the DEA before producing
Material. DEA quotas are limited, therefore, in order to assure
Celgene of the supplies agreed to hereunder, JMI agrees to use its
reasonable best efforts to obtain DEA manufacturing quota and
Celgene shall use its reasonable best efforts to cooperate with
JMI's request for manufacturing quota and obtain DEA procurement
quota sufficient to allow JMI to process Celgene orders for
Material.
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11.2 Each party's obligation hereunder is subject to obtaining the
necessary DEA quota. Neither party shall be liable to the other for
that quantity of Material which the other party is unable to supply
or take as a result of failure to obtain the necessary DEA quota so
long as it has used reasonable best efforts to obtain sufficient DEA
quota.
11.3 Each party shall use its best efforts consistent with reasonable
business practices and its obligations under this Agreement to
inform the other party of any hazards or precautions which need to
be taken, of which the party is or becomes aware, with respect to
the manufacture or handling of Material and Resolving Agent and the
use of Manufacturing Procedure during every phase under this
Agreement.
12. EARLY TERMINATION
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12.1 In addition to termination as provided for in Article 2, this
Agreement can be terminated by JMI for nonpayment of any sums due
hereunder (remaining unpaid for more than thirty (30) days after
notice to Celgene), or by either party at any time with 90 days'
advance written notice:
(i) on account of a material violation of the Agreement by the
other party, provided, however, that such notice shall be
null and void if the offending party cures the violation
before expiration of the ninety (90) days notice period; or
(ii) when the other party makes a general assignment for the
benefit of its creditors, has a custodian, receiver or any
trustee appointed for it or a substantial part of its
assets, commences any voluntary proceeding under any
bankruptcy law; or
(iii) when a court having jurisdiction over the other party shall
enter a decree or order for relief in any involuntary case
under applicable bankruptcy law and such decree or order
shall continue unstayed and in effect for a period of sixty
(60) days or more; or
(iv) product withdrawal by Celgene, FDA or DEA.
12.2 Termination for any reason by either party under this Article 12
shall not prejudice that party's remaining contractual rights
hereunder, including without limitation rights to direct damages,
nor terminate obligations set forth in Articles 7 and 17 hereof.
13. ENTIRE AGREEMENT
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13.1 This Agreement constitutes the entire agreement between the parties.
No modifications to, supplementation of, or addition of terms or
conditions to this Agreement, whether contained in any purchase
order, confirmation or otherwise, shall be effective unless made in
writing and signed by the party to be charged with modification. In
furtherance and not in limitation of the foregoing, the parties
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acknowledge and agree that the terms of the purchase orders issued
hereunder shall be binding for quantities and delivery dates only,
and any other terms and conditions contained thereon shall be of no
force and effect.
14. GOVERNING LAW
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14.1 This Agreement shall be interpreted in accordance with the laws of
the state of New Jersey where it is deemed to have been executed and
where both parties have their principal place of business relevant
to the subject matter of this Agreement.
15. ASSIGNMENT
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15.1 Neither party shall, without the prior written consent (not to be
unreasonably withheld or delayed) of the other party having been
obtained, assign or transfer this Agreement to any person on entity,
in whole or in part, provided that, each party may assign or
transfer this Agreement to any Affiliate or to any successor by
merger of such party or its pharmaceutical business to which this
Agreement relates, or upon a sale of all or substantially all of
such parties assets, or the assets or its pharmaceutical business to
which this Agreement relates, and provided further that Celgene may
assign this Agreement to NPC, in each case, without the prior
written consent of the other party hereto. All of the terms and
provisions of this Agreement shall be binding upon and inure the
benefit of and be enforceable by the parties hereto and their
respective successors and assigns. Notwithstanding the foregoing,
this Agreement is entered into solely for the benefit of the parties
hereto and not for the benefit of any other persons or entities. No
other persons or entities may enforce it for their benefit nor shall
they have any claim or remedy for its breach.
16. NOTICES
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16.1 All notices, requests, and other communications, hereunder shall be
deposited in the United States mail, registered or certified,
postage prepaid, addressed as follows:
If to Celgene: With a copy to:
Celgene Corporation Proskauer Rose LLP
7 Powder Horn Drive 1585 Broadway
Warren, NJ 07059 New York, NY 10036-8299
Attn: Joseph J. Day Jr. Attn: Robert A. Cantone
Senior Vice President
Planning & Business Development
If to JMI: With a copy to:
Johnson Matthey Inc. Johnson Matthey Inc.
2003 Nolte Drive 460 E. Swedesford Road
West Deptford, NJ 08066 Wayne, PA 19087
Attn: Vice President & Attn: Vice President &
General Manager General Counsel
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17. CONFIDENTIALITY
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17.1 Neither party shall disclose to any third party, except as may be
required by law in a manner that preserves confidentiality to the
maximum extent permitted by law, the substance of this Agreement.
All written information provided by either party to the other
hereunder including, but not limited to, volume requirements,
pricing, delivery schedules, and process data, is the disclosing
party's confidential information, as the same is defined in that
certain Confidentiality Agreement between the parties, dated
effective February 28, 2000, a copy of which is attached hereto as
Exhibit D and incorporated herein as if fully rewritten.
Notwithstanding anything to the contrary contained in such
Confidentiality Agreement, the receiving party agrees not to use or
disclose any such information or use such information except for
purposes of performance hereunder, and then only in a manner that
preserves confidentiality to the maximum extent permitted by law,
during the term of this Agreement and for a period of five (5) years
after the termination of this Agreement, provided that the receiving
party may use or disclose any such information that (1) is already
known to it at the time of disclosure to the receiving party; (2)
becomes publicly known through no fault of the receiving party; or
(3) is disclosed to the receiving party by a third party who is free
to make such disclosure.
17.2 Celgene, and NPC on behalf of Celgene, shall have the right, on
reasonable advance notice and during normal business hours, to
inspect JMI's facilities and operations to confirm compliance with
JMI's obligations under this Agreement; provided that JMI shall have
the right to safeguard its confidential information and information
that is subject to JMI's obligations of confidentiality to a third
party; provided further, that any inspection by NPC shall be
subject to he execution of a confidentiality agreement, on terms
reasonably satisfactory to JMI, between JMI and NPC.
18. NATURE OF AGREEMENT
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18.1 In operating under this Agreement, each party shall act
independently and this Agreement shall not be construed as creating
any partnership, joint venture or incorporated business entity.
Neither party shall have any authority to incur any liability or
obligation whatsoever on behalf of the other.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed by their duly authorized representatives.
CELGENE CORPORATION JOHNSON MATTHEY INC.
By /s/ Sol J. Barer By /s/ Forrest K. Sheff
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TYPED NAME: SOL J. BARER, PhD TYPED NAME: FORREST K. SHEFF
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TITLE: President & COO TITLE: Vice President/General Manager
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Date: 3/1/01 Date: 3/5/01
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March 5, 2001
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