EXHIBIT 10.50
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.
CELGENE CORPORATION
AND
EVOTEC OAI LIMITED
SUPPLY AGREEMENT
*** - indicates material omitted pursuant to a Confidential Treatment Request
and filed separately with the Securities and Exchange Commission.
INDEX
1 DEFINITIONS AND INTERPRETATION........................................1
2 PURCHASE AND SALE.....................................................3
3 PRICING...............................................................3
4 FORECASTS AND ORDERS..................................................4
5 SHIPMENT, INVOICES, DELIVERY..........................................5
6 PAYMENTS..............................................................7
7 TERM AND TERMINATION..................................................7
8 SUPPLY QUALITY AND SECURITY OF PRODUCT................................8
9 RECALLS..............................................................11
10 WARRANTIES...........................................................12
11 INDEMNITY............................................................12
12 FORCE MAJEURE........................................................13
13 PATENT INFRINGEMENT..................................................14
14 CONFIDENTIALITY AND INTELLECTUAL PROPERTY............................15
15 ASSIGNMENT...........................................................18
16 GOVERNING LAW........................................................18
17 WAIVER...............................................................19
18 SEVERANCE OF TERMS...................................................19
19 ENTIRE AGREEMENT/VARIATIONS..........................................19
20 NOTICES..............................................................20
21 COUNTERPARTS.........................................................20
22 REGISTRATION.........................................................21
23 INDEPENDENT CONTRACTORS..............................................21
24 COSTS................................................................21
i
*** - indicates material omitted pursuant to a Confidential Treatment Request
and filed separately with the Securities and Exchange Commission.
THIS AGREEMENT (hereinafter "Agreement") is made as of the 1st day of August
2004 BETWEEN:
(1) CELGENE CORPORATION, a Delaware corporation and having its business
address at 0 Xxxxxx Xxxx Xxxxx, Xxxxxx, Xxx Xxxxxx 00000, Xxxxxx Xxxxxx
of America (hereinafter CELGENE).
AND
(2) EVOTEC OAI LIMITED, a company incorporated in England and whose
registered office is at 000, Xxxxxx Xxxx, Xxxxxxxx, Xxxxxxxxxxx XX00
0XX, XX (hereinafter EOAI).
WHEREAS:
CELGENE is the owner of the compound known as CC-5013 and wishes to engage EOAI
to manufacture for CELGENE CC-5013 from time to time, as requested by CELGENE.
NOW THEREFORE, IT IS HEREBY AGREED AS FOLLOWS:
1 DEFINITIONS AND INTERPRETATION
1.1 In this Agreement and in the Appendices to this Agreement, the
following words and phrases shall have the following meanings unless
the context requires otherwise:
1.1.1 "Affiliate(s)" - shall mean any corporation, firm, partnership or other
entity, whether de jure or de facto, which directly or indirectly owns,
is owned by or is under common ownership with, a Party to this
Agreement to the extent of more then fifty percent (50%) of the equity
having the power to vote on or direct the affairs of the entity and any
person, firm, partnership, corporation or other entity actually
controlled by. controlling or under common control with a Party to this
Agreement.
1.1.2 "Batch" - shall mean a specific quantity of Bulk Compound that is
intended to have uniform character and quality, within specified
limits, and is produced according to a single manufacturing order
during the same cycle of manufacture.
1.1.3 "Bulk Compound" - shall mean a bulk quantity of the Compound as an
active pharmaceutical ingredient that has yet to be rendered into the
commercial dosage form.
1.1.4 "Business Day" - shall mean 09:00 hours to 17:00 hours on a day other
than a Saturday, Sunday, English bank or ether English or US public
holiday.
1.1.5 "cGMP" - means currant Good Manufacturing Practices as promulgated by
the FDA as detailed in Xxxxx 00, Xxxxxx Xxxxxx Code of Federal
Regulations, or when appropriate, any corresponding statutes and/or
regulations of any other country's prescription pharmaceuticals
regulating health authority or agency.
1.1.6 "Compound" - the compound known as CC-5013, being
3-(4-amino-1,3-dihydro-1-oxo-2H-isoindol-2-y)-2,6-piperidinedione.
*** - indicates material omitted pursuant to a Confidential Treatment Request
and filed separately with the Securities and Exchange Commission.
1.1.7 "Compound Specifications" - means the written physical and chemical
specifications for the Bulk Compound referenced in Appendix 1 hereto as
amended from time to time pursuant to Clause 8.5.
1.1.8 "Confidential Information" - means any information including, but not
limited to, ideas, proposals, plans, know-how, reports, drawings,
designs, data, discoveries, inventions, improvements, suggestions,
specifications (including the Compound Specifications), products,
samples, components and materials relating to the Compound and to the
Product, and all information relating to the manufacture, formulations,
analysis, stability, pharmacology, toxicology, pathology, clinical
data, results of clinical efficacy studies, clinical effects and
indications for use of the Product which a Party discloses, directly or
indirectly, to the other Party, so long as such information is
disclosed in writing and marked "confidential" or with a similar
legend; or if verbal, is reduced to writing and marked as such within
thirty (30) days of disclosure.
1.1.9 "Contract Price" - means the price par kilogram of Bulk Compound for
each Batch set forth in Clause 3.1.
1.1.10 "Contract Year" - means, for the first Contract Year, the period
commencing on the Effective Date and ending on 31st December 2004, and
for subsequent Contract Years the successive calendar years thereafter.
1.1.11 "Effective Date" - means August 1, 2004,
1.1.12 "FDA" - means the United States Food and Drug Administration and any
successor entity thereto.
1.1.13 "Force Majeure" - shall mean any significant, unexpected event which is
beyond the reasonable control of either Party and for which such Party
could not reasonably have been expected to have taken into account as
of the Effective Date.
1.1.14 "Party" or "Parties" - means CELGENE or EOAI or both as the context may
dictate.
1.1.15 "Producer Price Index" - shall mean the Producer Price Index for *** as
published by the Office of National Statistics (ONS) United Kingdom.
1.1.16 "Product"- means compound in finished form suitable for use by the
ultimate consumer, packaged and labeled for marketing.
1.1.17 "Purchase Order" - means a formal document issued by CELGENE containing
a firm order for delivery of Bulk Compound.
1.2 In this Agreement -
1.2.1 "References" - unless the context otherwise requires, all references to
a particular Clause, paragraph or Appendix shall be a reference to that
Clause, paragraph or Appendix, in or
2
*** - indicates material omitted pursuant to a Confidential Treatment Request
and filed separately with the Securities and Exchange Commission.
to this Agreement as the same may be amended from time to time pursuant
to this Agreement.
1.2.2 "Headings" - a table of contents and headings are inserted for
convenience only and shall be ignored in construing this Agreement.
1.2.3 "Gender/Plurality" - unless the contrary intention appears, words
importing the masculine gender shall include the feminine and VICE
VERSA and words in the singular include the plural and VICE VERSA.
1.2.4 "Person" - unless the contrary intention appears, words denoting
persons shall Include any individual, partnership, company,
corporation, joint venture, trust, association, organization or other
entity, in each case whether or not having separate legal personality.
1.2.5 "Include" - reference to the words "include" or "including" are to be
construed without limitation to the generality of the preceding words.
2 PURCHASE AND SALE
CELGENE shall purchase from EOAI and EOAI shall sell to CELGENE the
quantities of Bulk Compound ordered in accordance with Clause 4 hereof.
EON shall not at any time during the Term (as defined in Section 7.1
herein) or during the two-year period thereafter, manufacture the
Compound for any person or entity other than CELGENE or its
designee(s), without the prior written consent of CELGENE. which shall
not be unreasonably withheld.
3 PRICING
3.1 Price
The Contract Price to be paid by CELGENE to EOAI for each (***Kg) Batch
of Bulk Compound hereunder shall be as indicated below net of any
applicable Taxes (as defined in 3.2 below):
*** (in words: US Dollars ***) per Kg
The foregoing Contract Price shall be payable in United States Dollars
and shall be adjusted at the end of each Contract Year for all Bulk
Compound ordered during the ensuing Contract Year by a percentage equal
to the percentage change in the Producer Price Index during the twelve
(12) months preceding the change in the Contract Year.
Any other adjustment to the Contract Price due to external factors such
as raw material price changes can be implemented at any time through
the agreement of both Parties.
3
*** - indicates material omitted pursuant to a Confidential Treatment Request
and filed separately with the Securities and Exchange Commission.
3.2 Taxes
In the event that any national, federal, state, county, municipal or
other governmental excise, sales, import, export, stamp or other tax,
assessment, or other government-imposed charge (other than any tax
imposed upon the Income of EOAI) (collectively, "Taxes") is levied,
assessed or charged to EOAI on or for the sale, production or
transportation of the Bulk Compound sold to CELGENE, the Contract Price
shall be increased by an amount sufficient to cover such Taxes. Upon
request by CELGENE, EOAI shall promptly provide CELGENE with evidence
of payment of Taxes.
4 FORECASTS AND ORDERS
4.1 Initial Forecast
Attached hereto as Appendix 2 is the current forecast of the quantity
of Bulk Compound that CELGENE will require for the first twelve (12)
months of the Term (the "Initial Strategic Forecast"). The Initial
Strategic Forecast shall constitute a firm production order against
which CELGENE shall Issue Purchase Orders. CELGENE may, at its
discretion, issue Purchase Orders for quantities of Bulk Compound
forecast for delivery after the first twelve (12) months of the Term.
It is intended that the forecasts be used by EOAI to ensure appropriate
and timely replenishment of stock.
4.2 Rolling Forecast
On or about the first week of each January and July of each Contract
Year, CELGENE shall confirm to EOAI, or update as necessary, the
Initial Strategic Forecast (it being understood that the Initial
Strategic Forecast constitutes a firm production order according to
Clause 4.1) and each successive forecast subsequent thereto (each a
"Semi-Annual Forecast") for the ensuing twelve-month period of the
Term. The second six (6) months of each Semi-Annual Forecast shall
constitute a firm production order against which CELGENE shall issue
Purchase Orders.
4.3 Acceptance of Purchase Orders
Subject to any adjustment that may be desirable to match manufacturing
batch requirements and which shall be promptly notified to CELGENE,
EOAI shall accept firm Purchase Orders placed by CELGENE pursuant to
Clauses 4.1 and 4.2 above, within *** days of receipt, of such quantity
up to *** percent (***%) of the then current firm production order.
EOAI shall use commercially reasonable efforts, but shall not be
obligated, to supply any quantities ordered by CELGENE in excess of the
*** percent (***%) cap. Within *** days after EOAI receives CELGENE's
firm Purchase Order for quantities of Bulk Compound in excess of such
*** percent (***%) cap, EOAI shall notify CELGENE whether EOAI can
supply the quantities and by what date.
4
*** - indicates material omitted pursuant to a Confidential Treatment Request
and filed separately with the Securities and Exchange Commission.
4.4 Purchase Orders
CELGENE shall provide EOAI with Purchase Orders covering the firm
production orders detailed in Causes 4.1 and 42 above not less than ***
days after provision of the Initial Strategic Forecast and each
Semi-Annual Forecast, as applicable. Each Purchase Order made by
CELGENE shall be in writing and, in addition to any other terms or
requirements that the Parties may specifically establish in writing for
such Purchase Order, shall set forth the date by which the goods shall
be available for collection (the "Delivery Date'). EOAI shall make
available for collection each shipment of Bulk Compound on or before
the Delivery Date; provided that it is understood and agreed by the
Parties that EOAI shall not be obligated to make available Bulk
Compound by the Delivery Date set forth in any Purchase Order, which
Purchase Order is received by EOAI less than *** days prior to such
Delivery Date. The Delivery Date in such case shall be deemed to be ***
days after the date of receipt of the Purchase Order by EOAI.
4.5 Units to be Ordered and Minimum Order Quantity
Purchase Orders will be expressed in terms of Batch multiples. The
standard Batch size is *** kilograms, from which the actual Batch size
may vary by plus or minus *** percent (***%).
4.6 Conflicting Terms and Conditions
Except as otherwise provided in this Agreement, the terms and
conditions of this Agreement shall govern, notwithstanding any
additional or inconsistent terms or conditions in CELGENE's form of
Purchase Order or similar document or in EOAI's acknowledgement,
invoice or similar document.
5 SHIPMENT, INVOICES, DELIVERY
5.1 Title and Risk of Loss
Risk of loss for the Bulk Compound shall pass to CELGENE upon delivery
FCA Abingdon Incoterms 2000. Title shall pass to CELGENE on full
payment of the Contract Price to EOAI for the Bulk Compound.
5.2 Shipment
EOAI shall, as agent for CELGENE, arrange for shipment of Bulk Compound
covered by firm Purchase Orders from CELGENE pursuant to this Agreement
to the destination advised by CELGENE accompanied by Certificates of
Analysis for each Batch of Bulk Compound included in such shipment.
CELGENE shall be responsible for obtaining any necessary import and
export permits and the like for Bulk Compound. EOAI shall provide
reasonable assistance to CELGENE in this respect. Where Bulk Compound
available for shipment has not yet received quality control release,
CELGENE reserves the right to require in writing that such shipment be
made under quarantine.
5
*** - indicates material omitted pursuant to a Confidential Treatment Request
and filed separately with the Securities and Exchange Commission.
CELGENE shall provide EOAI with appropriate instructions for each
shipment of Bulk Compound designating the destination, including full
address details. Shipment shall not be made without specific
authorization of CELGENE. EOAI shall, as agent for CELGENE, be
responsible for arranging appropriate carriage and insurance and shall
invoice CELGENE for such reasonable out-of-pocket expenses. CELGENE
shall have its choice of carrier on this basis.
5.3 Invoices
At the date the Bulk Compound is accepted by the carrier, as authorized
by CELGENE pursuant to Clause 5.2 above, EOAI shall invoice CELGENE for
the Contract Price for the total Bulk Compound shipped. In the event
that Bulk Compound is stored at EOAI in accordance with the Agreement
for Storage referenced in Clause 5.5 below, EOAI will invoice CELGENE
upon placing the Bulk Compound into storage.
5.4 Addresses
Unless otherwise notified to the sending party in writing:
All Purchase Orders shall be sent to: Evotec OAI Ltd
000 Xxxxxx Xxxx
Xxxxxxxx, Xxxx XX00 0XX
Xxxxxx Xxxxxxx
Attn: ***
Tel: ***
Fax: ***
All shipments of Bulk Compound shall be sent to: to be informed
All invoices shall be sent to: Celgene Corporation
0 Xxxxxx Xxxx Xxxxx
Xxxxxx
Xxx Xxxxxx 00000
Xxxxxx Xxxxxx of America
Attn: ***
Tel: ***
Fax: ***
5.5 Storage
Contemporaneously with the execution and delivery of this Agreement,
the Parties hereto are executing and exchanging an Agreement for
Storage in the form attached as Appendix 3 hereto.
6
*** - indicates material omitted pursuant to a Confidential Treatment Request
and filed separately with the Securities and Exchange Commission.
6 PAYMENTS
Payment shall be due no later than *** days from the date of invoice.
Late payments shall attract interest at an annual rate of *** percent
(***%) above the base lending rate of Barclays Bank plc at of the date
such payment becomes past due and as may be adjusted from time to time.
Payment shall be made in *** by wire transfer to an account indicated
by EOAI, the details of which shall be notified to CELGENE by EOAI from
time to time.
7 TERM AND TERMINATION
7.1 Term
Except as provided in Clauses 7.2 and 7.3 below, the term of this
Agreement commences on the Effective Date and continues until the end
of the *** Contract Year (the "Term").
7.2 Renewal Term
The Term shall be automatically renewed for a period of *** upon the
end of the *** Contract Year and upon the end of each renewal period
unless either Party to this Agreement notifies the other in writing at
least *** prior to the commencement of such renewal that such renewal
shall not occur.
7.3 Early Termination
7.3.1 In addition to the provisions of Clauses 7.1 and 7.2 above, this
Agreement may be terminated prior to the expiration of the Term:
(a) by the non-breaching Party on *** written notice in the event
of materiel breach, or breach of a material term, of this
Agreement by the other Party which breach has not been
remedied by such other Party within such *** period; or
(b) by the non-defaulting Party on *** written notice (if
reasonable steps toward cure have not been made during such
time) if the other Party suspends payment of its debts or
otherwise ceases or threatens to cease to carry on its
business, becomes bankrupt or insolvent, goes into liquidation
(except for the purposes of reconstruction or amalgamation),
or compounds or enters into an arrangement with its creditors,
or a receiver or manager of the other Party's business is
appointed, or a petition is presented for the winding-up of
the other Party.
7.3.2 Notwithstanding Clause 7.2 above, CELGENE shall have the right to
terminate this Agreement for any reason upon *** prior written notice
to EOAI.
7.3.3 Upon the early termination of this Agreement by Celgene for any reason,
EOAI agrees to cooperate reasonably with CELGENE in good faith as may
be reasonably necessary to
7
*** - indicates material omitted pursuant to a Confidential Treatment Request
and filed separately with the Securities and Exchange Commission.
facilitate the timely qualification of an alternative manufacturer for
the Bulk Compound at Celgene's expense.
7.4 Effect of Termination
7.4.1 Survival of Liability
Termination under Clauses 7.1, 7.2 or 7.3 above shall not relieve
either Party of its liability for breach of its obligations pursuant to
the terms and conditions of this Agreement incurred prior to such
termination.
7.4.2 Stock
In the event of early termination by CELGENE under Clause 7.3.2 above,
CELGENE has the obligation to purchase from EOAI all usable stocks of
Bulk Compound then on hand not exceeding the amount of the then current
firm production order.
7.4.3 In case of early termination by EOAI under Clause 7.3.1 or by CELGENE
pursuant to Clause 7.3.2 above, CELGENE shall be responsible to EOAI
for all amounts for which EOAI is contractually obligated to its
contractors that are not Affiliates provided such contracts relate
solely to the production of Bulk Compound, and are not reasonably
avoidable, and provided further that EOAI uses commercially reasonable
efforts to mitigate same.
8 SUPPLY QUALITY AND SECURITY OF PRODUCT
8.1 Certificate of Analysis
EOAI shall test or cause to be tested each lot of Bulk Compound
according to the Compound Specifications pursuant to this Agreement
before delivery, and a Certificate of Analysis shall set forth the
items tested, specifications and test results for each lot delivered.
EOAI shall send or cause to be sent such certificates to CELGENE and to
CELGENE's designated subcontractor prior to shipment, together with the
delivery of Bulk Compound. CELGENE is entitled to rely on such
certificates for all purposes of this Agreement. Unless otherwise
requested in writing by CELGENE, EOAI shall release the Bulk Compound
to CELGENE or to CELGENE's designated subcontractor after testing
against the Compound Specifications.
8.2 Good Manufacturing Practices Audits
At CELGENE's request and upon fourteen (14) days prior notice to EOAI,
EOAI shall arrange CELGENE or CELGENE's agents (bound by
confidentiality obligations similar to those contained in its
Agreement) access during reasonable business hours to those areas of
EOAI's facilities where Bulk Compound is manufactured, analyzed, stored
and handled and to manufacturing, analytical and quality records of
Bulk Compound manufactured for CELGENE. Such visits shall be limited to
two (2) times per year, other
8
*** - indicates material omitted pursuant to a Confidential Treatment Request
and filed separately with the Securities and Exchange Commission.
than in extenuating circumstances. The right to access contained in
this Clause is exclusive of the rights discussed in the following
paragraph.
EOAI shall advise CELGENE immediately if an authorized agent of the FDA
or any other governmental agency visits or announces plans to visit any
of EOAI's manufacturing facilities concerning Bulk Compound. CELGENE
shall be entitled, where practicable and relevant, to be present at any
such inspection and, where notice of such inspection is available to
satisfy itself prior to such inspection that reasonable best efforts
are being made to ensure a satisfactory outcome of the inspection. EOAI
shall furnish to CELGENE the report by such agency of such visit and
the application of such report to Compound, if any, within forty-eight
(48) hours of EOAI's receipt of such report.
8.3 Discrepant Test Results
Notwithstanding Clause 8.1, on receipt of the Bulk Compound, CELGENE or
its designated subcontractor or agent may conduct analytical testing
within sixty (60) days of receipt of such Bulk Compound in accordance
with Clause 8.4. In the event of a discrepancy between EOAI's test
results and those of CELGENE or any of CELGENE's subcontractors or
agents, such that one set of results fall within the Compound
Specifications and the other results fall outside the Compound
Specifications and in the event that such discrepant results cannot be
resolved to both Parties' satisfaction, the Parties shall cause a
recognized independent testing laboratory to perform comparative tests
on samples of the allegedly defective Bulk Compound, provided that such
independent laboratory is mutually agreeable to the Parties. The
independent tester's results shall be final and binding. The costs of
the testing shall be borne by EOAI where EOAI's test results were found
by the independent tester to be erroneous and otherwise by CELGENE.
8.4 Defective Bulk Compound or Shortage of Supply
CELGENE shall notify EOAI in writing of any claim relating to damaged,
defective or non-conforming (with respect to this Agreement, the
Compound Specifications, applicable regulations or the like) Bulk
Compound or any shortage in quantity of any shipment of Bulk Compound
within *** days of receipt of such Bulk Compound (it being understood
that a *** day period is required for initial testing and standard
quality assurance testing of the Bulk Compound), or, in the case of
Bulk Compound having latent defects. which upon reasonable examination
within such *** day period could not have been discovered, within ***
days after discovery of such defect by CELGENE. The Parties agree that
in extenuating and unusual circumstances, such *** day limit shall be
extended to a reasonable time period under the circumstances. In the
event of such rejection or storage, EOAI shall, unless otherwise agreed
by the Parties or the cause of the rejection has been determined to be
not the fault of EOAI in accordance with Clause 8.3 above, (i) use its
commercially reasonably best efforts to replace the rejected or
shortage of Bulk Compound without undue delay but in no case greater
than the time quoted for the original manufacture and delivery, subject
to the provisions of Clause 12 of this Agreement (force majeure) and
raw material availability, at no extra cost to
9
*** - indicates material omitted pursuant to a Confidential Treatment Request
and filed separately with the Securities and Exchange Commission.
CELGENE, (ii) make arrangements with CELGENE for the return or
destruction of any rejected Bulk Compound, all associated costs to be
paid by EOAI, (iii) reimburse CELGENE for the shipping and related
charges in respect of rejected Bulk Compound, and (iv) with respect to
any shortage of Bulk Compound, bear the costs of shipping and insuring
such Bulk Compound to the extent that such costs, together with the
shipping and insurance costs of the original shipment, exceed the
shipping and insurance costs that would have been incurred had there
not been a shortage in the original shipment.
8.5 Compound Specifications; Cost of Changes
Compound Specifications may be modified from time to time as required
by applicable law or a regulation or regulatory authority, or otherwise
by written agreement of the Parties and such amended form shall be
attached hereto as a replacement for Appendix 1. The Parties agree that
in the event that material changes to the Compound Specifications
and/or EOAI's facility or processes are required by applicable law or
regulation, the expense of such changes shall be handled as follows:
(a) CELGENE shall be responsible for such out-of-pocket costs in
the event that the required changes are specific and unique to
EOAI's services related to CC-5013.
(b) EOAI shall be responsible for such costs in all other events,
which includes, without limitation, changes in regulations
which affect EOAI's work with clients other than CELGENE.
In addition, the change control provisions contained in 8.6 below shall
apply.
8.6 Change Control
Any change in relation to methods of manufacture, specifications, batch
size and packaging or in any of the plants in which Bulk Compound is
manufactured, packaged or stored, which reasonably could be deemed to
require regulatory amendment under US and/or EU regulations, shall be
subject to CELGENE's prior written approval which shall not be
unreasonably withheld. The Parties will co-operate in ensuring any
necessary regulatory amendments are obtained. No changes that require
regulatory amendment shall be implemented until all necessary
regulatory approvals have been obtained.
8.7 Shelf Life
All Bulk Compound delivered shall have at least *** months remaining
prior to its re-test date, as such date is determined by the Compound
Specifications.
8.8 Equipment
EOAI agrees that it currently possesses or will purchase and maintain,
at its sole cost and expense unless otherwise agreed by the Parties,
all equipment required to perform the services required of it under
this Agreement. Any changes to be made to equipment shall be in
compliance with the applicable regulatory authority's guidelines and
requirements.
10
*** - indicates material omitted pursuant to a Confidential Treatment Request
and filed separately with the Securities and Exchange Commission.
No such changes shall be made by EOAI without the prior written consent
of CELGENE, such consent not to be unreasonably withheld.
8.9 Facility.
All manufacturing pursuant to this Agreement shall be performed at
EOAI's manufacturing facility located at Xxxx 000 Xxxxxx Xxxx,
Xxxxxxxx, Xxxx XX00 0XX, Xxxxxx Xxxxxxx. Any changes to be made by EOAI
with respect to manufacturing building, facilities and batch size shall
be in compliance with the applicable regulatory authority's guidelines
and requirements. No such changes shall be made by EOAI without the
prior written consent of CELGENE, which shall not be unreasonably
withheld.
8.10 Subcontracting.
Except as otherwise expressly provided in this Agreement, EOAI shall
not subcontract any manufacturing of Bulk Compound or its intermediates
without the prior written consent of CELGENE.
EOAI shall be allowed to subcontract analytical services (such as ***
and ***) without prior consent of CELGENE provided that such
subcontractors have been approved by CELGENE in writing for the
specific services to be rendered by same and such subcontractors are
bound by confidentiality and intellectual properly obligations no less
strict than the use of this Agreement.
9 RECALLS
9.1 In the event that
(a) any government authority issues a request, directive or order
that the Product and/or Bulk Compound be recalled; or
(b) a court of competent jurisdiction orders such a recall; or
(c) CELGENE reasonably determines after consultation with its
subcontractors and/or EOAI that the Product and/or Bulk
Compound should be recalled.
CELGENE shall take all appropriate corrective actions, and EOAI shall
provide reasonable assistance at CELGENE's request.
9.2 To the extent that any such recall is caused by EOAI's breach of any
term of this Agreement including but not limited to a warranty set
forth in Clause 10 or EOAI's breach of statutory duty or out of the
negligence or intentional misconduct of EOAI, EOAI shall be responsible
for the cost of the recall provided that EOAI shall not be responsible
for the cost of any recall to the extent it is not caused by any such
breach, but by an inherent problem associated with the Compound, the
registered process and/or the Compound Specifications.
11
*** - indicates material omitted pursuant to a Confidential Treatment Request
and filed separately with the Securities and Exchange Commission.
9.3 For the purposes of this Agreement, the expenses of recall shall
include, without limitation, the expenses of notification, refund and
destruction or return of the recalled Product and/or Bulk Compound,
where appropriate, and the Contract Price for the Bulk Compound
recalled.
10 WARRANTIES
10.1 Title
EOAI warrants to CELGENE that EOAI shall convey good title to the Bulk
Compound.
10.2 Compliance with Applicable Regulations and Good Manufacturing
Practices; Conformity with Specifications
10.2.1 EOAI warrants and covenants that:
(a) its manufacturing facilities utilized for the manufacture of
Bulk Compound comply and will comply throughout the Term with
applicable regulations of the US and EU, including, without
limitation, applicable cGMP;
(b) the processes utilized for the manufacture of Bulk Compound
are and will be throughout the Term in accordance with those
contained in the registered marketing authorization;
(c) all the Bulk Compound will conform to the Compound
Specifications when delivered; and
(d) the Bulk Compound shall have been manufactured in accordance
with the registered process and applicable cGMP.
10.3 Insurance
EOAI will maintain for the duration of its liabilities under this
Agreement, product liability insurance of no less than *** pounds
((pound)***) cover, per calendar year, with a reputable insurer.
Evidence of such cover and its renewal shall be provided to CELGENE
annually in writing. In the event that at such policy is cancelled or
not renewed for any reason, CELGENE shall be immediately notified in
writing at least thirty (30) days prior to such cancellation or
non-renewal.
11 INDEMNITY
11.1 EOAI Indemnity
CELGENE shall defend, indemnify and hold harmless EOAI and its
respective officers, directors and employees (the "EOAI Indemnified
Parties") from and against any and all claims, suits, demands, actions,
causes of action, liabilities, damages, costs and expenses (including,
without limitation, court costs and reasonable attorneys' fees and
expenses)
12
*** - indicates material omitted pursuant to a Confidential Treatment Request
and filed separately with the Securities and Exchange Commission.
incurred by the EOAI Indemnified Parties in connection with any third
party claim to the extent arising out of or in connection with any Bulk
Compound supplied to CELGENE by EOAI pursuant to this Agreement and/or
any products manufactured using such Bulk Compound except to the extent
such third party claim arises out of EOAI's breach of any term of this
Agreement including but not limited to any warranties set forth in
Clause 10 or the breach of statutory duty by any EOAI Indemnified
Party(ies) or out of the negligence or intentional misconduct of any
EOAI Indemnified Party(ies).
11.2 CELGENE's Indemnity
EOAI shall defend, indemnify and hold harmless CELGENE and its
respective officers, directors and employees (the "CELGENE Indemnified
Parties") from and against any and all claims, suits, demands. actions,
causes of action, liabilities, damages, costs and expenses (including,
without limitation, court costs and reasonable attorneys' fees and
expenses) incurred by the CELGENE Indemnified Parties in connection
with any third party claim to the extent that such liability arises
from EOAI's breach of any term of this Agreement including but not
limited to any warranties set forth in Clause 10 or the breach of
statutory duty by any EOAI Indemnified Party(ies) or out of the
negligence or intentional misconduct of any EOAI Indemnified
Party(ies).
11.3 Notice of Claim
The indemnified Party shall:
(a) advise the indemnifying Party in accordance with Clause 20
below of any claim or lawsuit, in writing, as soon as
practicable, but not later than fourteen (14) days after the
indemnified Party has received notice of said claim or
lawsuit; and
(b) assist the indemnifying Party and its representatives in the
investigation and defense of any lawsuit and/or claim for
which indemnification is provided, but allow the indemnifying
Party to maintain control over the action.
The failure to timely provide the notice under (a) above shall not
relieve the indemnifying party of its obligations under this Clause 11
except to the extent that such failure substantially prejudices the
defense of such third party claim. The indemnity provided in this
Clause 11 shall not be valid as to any settlement of a claim or lawsuit
or offer of settlement or compromise made without the prior written
approval of the indemnifying Party.
11.4 The obligations of the Parties under this Clause 11 shall survive the
expiration or termination of this Agreement.
12 FORCE MAJEURE
12.1 Force Majeure Events
13
*** - indicates material omitted pursuant to a Confidential Treatment Request
and filed separately with the Securities and Exchange Commission.
If a Party (the "Non-Performing Party) shall be unable to carry out any
of its obligations under this Agreement due to Force Majeure, this
Agreement shall remain in effect but the Non-Performing Party's
relevant obligations and the relevant obligations of the other Party
(the "Innocent Party") owed to the Non-Performing Party under this
Agreement shall be suspended for a period equal to the circumstance of
Force Majeure or three (3) months, whichever is the shorter, provided
that
(a) the suspension of performance is of no greater scope than is
required by the Force Majeure;
(b) the Non-Performing Party gives the Innocent Party prompt
notice describing the circumstances of Force Majeure,
including the nature of the occurrence and its expected
duration, and continues to furnish regular reports with
respect thereto during the period of Force Majeure;
(c) the Non-Performing Party uses all reasonable efforts to remedy
its inability to perform and to mitigate the effects of the
circumstances of Force Majeure;
(d) as soon as practicable after the event which constitutes Force
Majeure the Parties shall discuss how best to continue their
operations as far as possible in accordance with this
Agreement and
(e) any payment obligations relating to periods of excused
performance shall also be excused and any advance payments for
periods of excused performance shall be refunded.
12.2 Consequences of Force Majeure
Upon the occurrence of an event of Force Majeure, the Non-Performing
Party shall promptly notify the Innocent Party in writing, setting
forth the details of the occurrence, its expected duration and how the
Non-Performing Party's performance is affected. The Non-Performing
Party shall resume the performance of its obligations as soon as
practicable after the Force Majeure event ceases. In the event that
EOAI is unable to deliver all the Bulk Compound ordered by CELGENE for
a particular period as a result of an event of Force Majeure, CELGENE
may elect to forego the quantities ordered or it may elect to take
delivery within a reasonable period of time after the Force Majeure
event ceases.
13 PATENT INFRINGEMENT
13.1 CELGENE's Warranty and Indemnity
CELGENE warrants that, to the best of its knowledge, the manufacture,
use or sale of the Product and/or Bulk Compound does not infringe or
misappropriate any patent or other proprietary rights of any third
party. CELGENE shall defend, indemnify and hold EOAI harmless against
any judgment, damage, liability, loss, cost or other expense, including
reasonable legal fees, to the extent resulting from any breach of this
warranty.
14
*** - indicates material omitted pursuant to a Confidential Treatment Request
and filed separately with the Securities and Exchange Commission.
13.2 Co-operation and Consultation
Each Party shall give the other Party prompt notice of any threatened
or pending claim or proceeding against either or both Parties relating
to a claim of infringement described In Clause 13.1 above. In the event
of such notice and at the request of either Party, CELGENE shall assume
control as stated in Clause 13.3 below, but agrees to consult with EOAI
regarding how to proceed with respect to such claim or proceeding.
13.3 Defense by CELGENE
CELGENE shall assume full control of the defense of such claim or
proceeding described in Clause 11.1 above.
14 CONFIDENTIALITY AND INTELLECTUAL PROPERTY
14.1 During the Term of this Agreement and for a period of ten (10) years
thereafter, neither Party shall disclose Confidential Information
received from the other Party (the "Disclosing Party") hereunder
without the Disclosing Party's prior written consent, or use or permit
to be used the Disclosing Party's Confidential Information for any
other purpose than the performance of its obligations or rights under
this Agreement. Each Party shall procure that all employees and other
persons having access to any Confidential Information are informed of
its secret and confidential nature and to the extent reasonably
practicable are subject to written obligations similar to those of the
Parties in this Clause 14.
14.2 No public announcement or other disclosure to third parties concerning
the structure and financial terms of this Agreement shall be made
either directly or indirectly by any Party to this Agreement except as
may be legally required without first obtaining the approval of the
other Party and agreement upon the nature and text of such announcement
or disclosure which approval and agreement shall not be unreasonably
delayed or withheld, provided that in the case of any disclosure
required by either Party's investment bankers, lawyers, accountants and
other professional advisors, such Party shall not need to seek the
other Party's prior approval, provided that such disclosure is made
under terms of strict confidentiality and the detail of terms disclosed
shall be kept to the minimum required by such investment bankers or
other professional advisers.
In all circumstances, including where disclosure is legally required,
the Party desiring to make any such public announcement or other
disclosure shall inform the other Party of the proposed announcement or
disclosure in, so far as practicable, reasonably sufficient time prior
to public release and shall provide the other Party with a written copy
thereof in order to allow such other Party to comment upon such
announcements or disclosure.
Each Party shall co-operate fully with the other with respect to all
disclosures regarding this Agreement to the US Securities Exchange
Commission, the Frankfurt Stock Exchange and any other governmental or
regulatory agencies including requests for confidential treatment of
information of other Party included in any such disclosure.
15
*** - indicates material omitted pursuant to a Confidential Treatment Request
and filed separately with the Securities and Exchange Commission.
14.3 Neither during the Term of this Agreement, nor for a period of ***
years thereafter, shall EOAI submit for written or oral publication any
manuscript, abstract or the like which includes data or other
information generated in the course of this Agreement or otherwise
provided by either Party and relating to the Compound or Product
without first obtaining the prior written consent of CELGENE, which
consent shall not be unreasonably withheld or delayed. Wherever
reasonably possible, the contribution of each Party shall be noted in
all publications and presentations by acknowledgement or co-authorship,
whichever is appropriate.
14.4 The obligations of confidentiality referred to in this Clause 14 shall
not extend to any information which:
(a) is or shall be generally available to the public otherwise
than by reason of breach by the Party to whom such information
was disclosed ("the Recipient Party") of the provisions of
this Clause 14;
(b) is known to the Recipient Party and is at its free disposal
prior to its receipt from the Disclosing Party as demonstrated
by the written records of the Recipient Party. Should the
Disclosing Party reasonably believe that the Recipient Party
is planning to disclose Confidential Information of the
Disclosing Party, then the Disclosing Party may, by written
request, ask the Recipient Party to provide copies of its
written records which demonstrate the Recipient Party's prior
knowledge of such information. The Recipient Party shall
provide such written demonstration within forty (40) Business
Days after the Disclosing Party's written request. If the
Recipient Party does not provide such written evidence or if
the Parties disagree as to whether such written evidence
establishes the Recipient Party's prior knowledge of such
information, then the Recipient Party shall not make such
planned disclosure unless and until such time as a neutral
party has ruled with respect to this Issue in Recipient
Party's favor. The Parties shall promptly appoint a neutral
party to determine whether or not such information is the
Confidential Information of the Disclosing Party;
(c) is independently developed by or for the Recipient Party
without reference to, and by employees having no knowledge of,
the Confidential Information of the Disclosing Party, as
referenced by written records, provided that conclusive
evidence of such knowledge is furnished by the Recipient Party
to the Disclosing Party within twenty-eight (28) days of
receipt of demand for such proof;
(d) is subsequently disclosed to the Recipient Party without
obligation of confidence by a third party owing no such
obligations in respect thereof;
(e) is required by law to be disclosed, provided that the
provisions of Clause 14.6 are followed; or
16
*** - indicates material omitted pursuant to a Confidential Treatment Request
and filed separately with the Securities and Exchange Commission.
(f) is required to be disclosed to any regulatory authority when
applying for a license to conduct clinical or other trials or
studies or for regulatory, marketing or pricing approval.
14.5 The obligations of the Parties under this Clause 14 shall survive the
expiration or termination of this Agreement.
14.6 Each Party shall immediately notify the other Party of receipt of any
process. subpoena, or demand by any governmental authority or any other
person requiring production of Confidential Information of the other
Party and shall, within five (5) Business Days after receipt, provide
the other Party with a copy of such process, subpoena, or demand and,
as available, all materials and facts relating and responsive thereto.
The Party whose Confidential Information is the subject of such
process, subpoena, or demand shall have the right to take any legal
action to prevent disclosure of its Confidential Information. The Party
in receipt of such demand for disclosure shall reasonably assist the
first Party in attempting to limit such disclosure.
14.7 EOAI agrees that any and all right, title and interest in and to any
patentable and/or copyrightable material, notes, data, results,
records, inventions, improvements, developments, discoveries and trade
secrets made, conceived, reduced to practice, or discovered in the
performance of this Agreement that consists of or relates to the
Compound or the Product, the use, manufacture or formulation thereof,
or any other material, product or process belonging to CELGENE or its
licensors, or to any improvement(s), enhancement(s) or refinements of
any of same, shall be the sole property of CELGENE ("CELGENE
Inventions"). EOAI further agrees to assign (or cause to be assigned)
and does hereby assign fully to CELGENE all such CELGENE Inventions and
any patents, copyrights or other intellectual property rights relating
thereto. In addition, to the extent allowed by law, any CELGENE
Inventions which constitute copyrightable subject matter shall be
considered "works made for hire" as that term is defined in the United
States Copyright Act. All CELGENE Inventions and any information with
respect thereto shall be deemed CELGENE's Confidential Information
subject to the confidentiality provisions set forth in this Agreement.
EOAI shall disclose all CELGENE Inventions to CELGENE promptly after
EOAI becomes aware of the making, conception, reduction to practice or
discovery of same. CELGENE shall grant to EOAI an irrevocable,
perpetual, non-exclusive, royalty-free license to practice the CELGENE
Inventions only in connection with the development or manufacturing of
products other than (i) the Compound, (ii) any specific intermediates
in the synthesis route of the Compound, and (iii) diastereoisomers of
the Compound. The foregoing license grant shall include the right to
sublicense solely to those of EOAI's customers that have purchased
development or manufacturing services from EOAI and have a bona fide
need to practice the CELGENE Inventions in connection therewith, in
each case subject to CELGENE's prior written consent, not to be
unreasonably withheld.
14.8 Upon the expiration or termination of this Agreement, or upon CELGENE's
earlier request, EOAI shall deliver to CELGENE all of CELGENE's
property relating to, and all tangible embodiments of, CELGENE
Inventions in EOAI's possession or control.
17
*** - indicates material omitted pursuant to a Confidential Treatment Request
and filed separately with the Securities and Exchange Commission.
14.9 EOAI agrees to assist CELGENE, or CELGENE's designee, at CELGENE's
expense, to obtain and from time to time enforce and defend CELGENE's
rights in the CELGENE Inventions and any copyrights, patents or other
intellectual property rights relating thereto in any and all countries,
and to execute all documents reasonably necessary for CELGENE to do so.
14.10 EOAI agrees that if CELGENE is unable using commercially reasonable
efforts, because of EOAI's unavailability (only for the specific act to
be performed), dissolution, or refusal, to secure EOAI's signature to
apply for or to pursue any application for any United States of America
or foreign patents or copyright registrations covering the CELGENE
Inventions assigned to CELGENE as provided herein, then EOAI hereby
irrevocably designates and appoints CELGENE and CELGENE's duly
authorized officers and agents as EOAI's agent and attorney-in-fact, to
act for and in EOAI's behalf and stead to execute and file any such
applications and to do all other lawfully permitted acts to further the
prosecution and issuance of patents and copyright registrations thereon
with the same legal force and effect as if executed by EOAI.
14.11 EOAI represents and warrants that each employee of EOAI, and each
independent contractor of EOAI, if any, performing any work under this
Agreement has executed an agreement with EOAI containing provisions in
CELGENE's favor substantially similar to Clause 14.7 through 14.10
above, including, without limitation, an obligation to assign any and
all CELGENE Inventions to EOAI or CELGENE.
15 ASSIGNMENT
Save as otherwise provided in this Agreement, neither Party may assign,
transfer, charge or in any other manner make over to any third party
the benefit and/or burden of this Agreement or encumber this Agreement
in any way, unless that other Party has consented in writing to the
change, such consent not to be unreasonably withheld or delayed.
Notwithstanding the foregoing. CELGENE may assign this Agreement to an
Affiliate, or in connection with a merger or sale of all or
substantially all its assets, or a sale, license or other disposition
of CELGENE's business related to the Compound, without the prior
consent of EOAI, provided that the assignee agrees to abide by this
Agreement.
16 GOVERNING LAW
The validity, construction and performance of this Agreement shall be
governed by the laws of the State of New York, USA, without giving
effect to the principles of conflicts of law thereof. In the event of
any controversy or claim arising out of or relating to any provision of
this Agreement or the breach thereof, the parties hereto will try to
settle their differences amicably by themselves. Any such controversy
or claim which the parties hereto are unable to resolve shall initially
be submitted for review and resolution by the chief executive officers
of the parties hereto. Any action, suit or other proceeding initiated
by either party hereto under or in connection with this Agreement shall
be brought only in any Federal or state court in the State of New York
having jurisdiction over the subject matter thereof, as the party
hereto bringing such action, suit or
18
*** - indicates material omitted pursuant to a Confidential Treatment Request
and filed separately with the Securities and Exchange Commission.
proceeding shall elect. The parties hereto submit themselves to the
jurisdiction of any such court and agree that service of process on
them in any such action, suit or proceeding may be effected by the
means by which notices are to be given to it pursuant to this
Agreement.
17 WAIVER
Neither Party shall be deemed to have waived any of its rights or
remedies whatsoever unless such waiver is made in writing and signed by
a duly authorized representative of that Party. In particular, no delay
or failure of either Party in exercising or enforcing any of its rights
or remedies whatsoever shall operate as a waiver thereof or so as to
preclude or impair the exercise or enforcement thereof nor shall any
partial exercise or enforcement of any such right or remedy by either
Party preclude or impair any other exercise or enforcement thereof by
such Party.
18 SEVERANCE OF TERMS
18.1 If the whole or any part of this Agreement is or shall become to be
declared illegal, invalid or unenforceable in any jurisdiction for any
reason whatsoever (including both by reason of the provision of any
legislation and also by reason of any decision of any court of
competent authority either having jurisdiction over this Agreement or
having jurisdiction over either of the Parties to this Agreement):
18.1.1 In the case of the illegality, validity or unenforceability of the
whole of this Agreement, it shall terminate in relation to the
jurisdiction in question; or
18.1.2 In the case of the illegality, invalidity or unenforceability of part
of this Agreement, such part shall be severed from the Agreement, or
modified to the extent required to allow enforceability, in the
jurisdiction in question, and such illegality, invalidity or
unenforceability shall not in any way whatsoever prejudice or affect
the remaining parts of this Agreement which shall continue in full
force and effect provided always that if in the reasonable opinion of
either Party any such severance materially affects the commercial basis
of this Agreement, such Party shall notify the other Party, whereby the
Parties shall meet and in good faith try to replace the part of the
Agreement so held illegal, invalid or unenforceable.
19 ENTIRE AGREEMENT/VARIATIONS
19.1 This Agreement between the Parties constitutes the entire agreement and
understanding between the Parties in relation to the commercial supply
of Bulk Compound and supersedes all prior oral or written
understandings, arrangements, representations or agreements between
them relating to this subject matter.
19.2 No variation, amendment, modification or supplement to this Agreement
shall be valid unless made in writing in the English language and
signed by a duly authorized representative of each Party.
19
*** - indicates material omitted pursuant to a Confidential Treatment Request
and filed separately with the Securities and Exchange Commission.
20 NOTICES
20.1 Save as otherwise expressly provided in this Agreement any notice or
other communication to be given by any person to any other person
pursuant to this Agreement shall be in writing and in the English
language and shall be delivered by hand or sent by first class prepaid
post or facsimile, and shall be addressed to the recipient and sent to
the address or facsimile number of the recipient set out below, marked
for the attention of the representative set out below or to such other
address and/or facsimile number or marked for such other attention as
such recipient may from time to time specify by notice given in
accordance with this Clause 20 to the Party giving the relevant notice
or other communication to it and shall be deemed to have been received:
20.1.1 In the case of delivery by hand, when delivered; or
20.1.2 In the case of first class prepaid post, on the fifth (5th) day
following the day of posting; or
20.1.3 In the case of facsimile, on acknowledgement by the recipient facsimile
receiving equipment on a Business Day provided that such
acknowledgement occurs before 17:00 hours local time of the recipient
on the Business Day of acknowledgement and in any other case on the
Business Day next following having the Business Day of acknowledgement.
CELGENE: Celgene Corporation
0 Xxxxxx Xxxx Xxxxx
Xxxxxx, Xxx Xxxxxx 00000
Xxxxxx Xxxxxx of America
Attention: ***
Tel: ***
Fax: ***
EOAI: Evotec OAI Limited
000 Xxxxxx Xxxx
Xxxxxxxx
Xxxxxxxxxxx XX00 0XX
Xxxxxx Xxxxxxx
Attention: ***
Tel: ***
Fax: ***
21 COUNTERPARTS
This Agreement may be executed in two counterparts and by the different
Parties hereof by separate counterparts, each of which when so executed
shall be an original, and both of which shall constitute one and the
same instrument. Complete sets of counterparts shall be lodged with
each Party.
20
*** - indicates material omitted pursuant to a Confidential Treatment Request
and filed separately with the Securities and Exchange Commission.
22 REGISTRATION
Either Party shall have the right at any time where commercially or
legally necessary or desirable to record, register or otherwise notify
this Agreement to appropriate governmental or regulatory offices having
first given thirty (30) days' written notice to the other Party of its
intention so to do. The Party seeking to record, register or otherwise
notify this Agreement shall give due consideration to any comments or
reasonable request made by the other Party in relation to such
recording, registering or notifying. The other Party shall provide
reasonable assistance in affecting such recording, registering or
notifying.
23 INDEPENDENT CONTRACTORS
None of the provisions of this Agreement shall be deemed to constitute
a partnership or joint venture between the Parties and none of them
shall have any authority to bind the others in any way except as
provided in this Agreement.
24 COSTS
Each Party shall bear its own legal costs, legal fees and other
expenses incurred in the preparation and execution of this Agreement.
[Signature Page Follows]
21
*** - indicates material omitted pursuant to a Confidential Treatment Request
and filed separately with the Securities and Exchange Commission.
IN WITNESS WHEREOF the Parties have executed this document as an Agreement the
date and year first above written.
For and on behalf of ) /s/ ***
----------------
CELGENE CORPORATION )
)
----------------
Legal
Dept ***
For and or behalf of ) /s/ ***
----------------
EVOTEC OAI LIMITED ) ***
----------------
***
22
*** - indicates material omitted pursuant to a Confidential Treatment Request
and filed separately with the Securities and Exchange Commission.
AMENDMENT TO THE SUPPLY AGREEMENT
This Amendment, effective October 25, 2004, is an amendment to the
Supply Agreement effective October __, 2004 (the "Agreement") between Celgene,
Inc., having an address at 0 Xxxxxx Xxxx Xxxxx, Xxxxxx XX 00000, XXX
(hereinafter "Celgene") and Evotec OAI Ltd., having an address at 000 Xxxxxx
Xxxx, Xxxxxxxx, Xxxxxxxxxxx XX00 0XX, XX (hereinafter "EOAI").
WHEREAS, Celgene and EOAI wish to revise the per kilogram price in
clause 3.1 of the Agreement as a result of the introduction of an additional
water slurry to guarantee the Polymorph ***.
The revised price per kilogram for a batch size of *** kilograms
(***Kg) shall be ***.
In all other respects, the Agreement shall remain in full force and
effect, unless further amended by written agreement.
IN WITNESS WHEREOF, the parties hereto have duly executed this
Amendment effective the day and year first above-written.
Celgene, Inc.
By. ***
------------------------------------
Name: ***
----------------------------------
Title: ***
---------------------------------
Evotec OAI, Ltd.
By. ***
------------------------------------
Name: ***
----------------------------------
Title: ***
---------------------------------
*** - indicates material omitted pursuant to a Confidential Treatment Request
and filed separately with the Securities and Exchange Commission.
