Exhibit 10.68
CONFIDENTIAL TREATMENT REQUESTED
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PENICILLIN G POTASSIUM MANUFACTURING AND SUPPLY AGREEMENT
AGREEMENT, effective February 15, 2000, between Pfizer Inc ("Pfizer"), a
Delaware corporation with an office at 000 Xxxx 00xx Xxxxxx, Xxx Xxxx, XX 00000,
and Schein Pharmaceutical, Inc. ("Schein"), a Delaware corporation with an
office at 000 Xxxxxx Xxxxx, Xxxxxxx Xxxx, XX 00000.
In consideration of the mutual covenants and agreements provided herein,
the parties agree as follows:
SECTION 1.0 DEFINITIONS
1.1 "Raw Material" means bulk sterile penicillin G potassium furnished by
Schein from an inventory of material currently on hand that had been
manufactured by * in its * manufacturing facility and conforming to
the specifications including test procedures set forth in Exhibit 1
as amended from time to time by agreement of the parties.
1.2 "Product" means packed and labeled finished dosage forms in vials
containing penicillin G potassium for injection and conforming to the
specifications including test procedures set forth in Exhibit 2 as
amended from time to time by agreement of the parties.
1.3 "Pfizer Product" shall have the meaning as set forth in Section 2.2.
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* Material omitted pursuant to a request for confidential treatment. The
omitted material has been filed separately with the Securities and Exchange
Commission.
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1.4 "Yield" means the amount of Product meeting the specifications set
forth in Exhibit 2 expressed as a percentage of the theoretical amount
of Product from the Raw Material processed.
1.5 "Minimum Yield" means the minimum percentage Yield for the total of
the lots processed during a calendar year. The Minimum Yield shall be
*.
SECTION 2.0 MANUFACTURE OF PRODUCT AND SUPPLY OF RAW MATERIAL
2.1 Pfizer will receive Raw Material and deliver manufactured Product to
Schein as requested by Schein in its orders and according to the terms set forth
hereunder and in Exhibit 2 and Exhibit 3. Schein will provide Pfizer, at * to
Pfizer, freight to be paid by Schein, and no later than 2 months prior to the
quarter in which delivery is due, the amount of Raw Material required by
Pfizer to fill orders placed by Schein.
2.2 Schein will also supply to Pfizer, at a price set forth in Section 3.2,
Raw Material for the manufacture by Pfizer of Product for sale by Pfizer as
requested in Pfizer's orders and according to the terms set forth hereunder.
Product for sale by Pfizer shall hereinafter be referred to as "Pfizer Product".
2.3 Primary packaging material (material coming into direct contact with
Product) supplied by Pfizer must comply with the specifications agreed to by
Schein and Pfizer. Pfizer will use commercially reasonable efforts in the
qualification and selection of suppliers and will notify Schein of any changes.
2.4 Schein will provide text and artwork for secondary packaging
material (printed material) and may request revisions from time to time,
provided that all text is consistent with
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* Material omitted pursuant to a request for confidential treatment. The
omitted material has been filed separately with the Securities and Exchange
Commission.
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Pfizer's New Drug Application for Pfizerpen(R). Pfizer and Schein will
cooperate in implementing any required revisions within an appropriate
timeframe.
SECTION 3.0 PRICES
3.1 The prices Schein shall pay Pfizer to manufacture Product for Schein
pursuant to this Agreement are set forth in Exhibit 3.
3.2 Pfizer shall pay Schein * per billion units (BU), freight to be paid
by Pfizer from Schein's Marsam facility in Cherry Hill, NJ to Pfizer's Terre
Haute, Indiana manufacturing facility, for all Raw Material supplied by Schein
for the manufacture by Pfizer of Pfizer Product.
3.3 Pfizer will invoice Schein for all Product actually delivered pursuant
to this Agreement. Pfizer's invoice will be payable by Schein within 30 days.
3.4 Subject to the provisions of Section 6.0 hereof, Schein will invoice
Pfizer for all Raw Material actually delivered to Pfizer pursuant to this
Agreement for the manufacture by Pfizer of Pfizer Product as requested by Pfizer
in its orders and according to the terms set forth hereunder.
SECTION 4.0 QUANTITIES AND PURCHASE ORDERS FOR PRODUCT
4.1 Pfizer agrees to manufacture for Schein, on the basis set forth herein,
Schein's requirements for Product during the term of this Agreement, up to *
vials of Product each calendar quarter, subject to available capacity.
4.2 As of the date of the signing of this Agreement, Schein will provide
to Pfizer, subject to Pfizer's acceptance, a firm purchase order covering the
remainder of the first calendar quarter and the second calendar quarter of
calendar year 2000 (the "Initial Purchase Order").
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* Material omitted pursuant to a request for confidential treatment. The
omitted material has been filed separately with the Securities and Exchange
Commission.
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Within 15 days of the date of Pfizer's receipt of Schein's Initial Purchase
Order, Pfizer will advise Schein in writing whether, based on Pfizer's
planned capacity utilization, Pfizer is able to supply the quantities within
the time periods set forth in the Initial Purchase Order. If Pfizer advises
that it can not supply the ordered quantities within the time frames set
forth in the Initial Purchase Order, the parties shall meet to discuss what
quantities Pfizer can supply; provided that, in such case, in accordance with
Section 4.5 hereof at least 50% of any Product planned by Pfizer to be
manufactured during such period shall be allocated to Schein. For each
calendar quarter thereafter, Schein will place firm purchase orders for
Product at least 90 days prior to the beginning of such calendar quarter.
Pfizer will review such purchase orders based on Pfizer's planned capacity
utilization and advise Schein in writing within 15 days of Pfizer's receipt
of the purchase order whether Pfizer can supply quantities with in the time
periods set forth in the purchase order. If Pfizer advises that it can not
supply the ordered quantities with in the time periods set forth in the
purchase order, the parties shall meet to discuss what quantities Pfizer can
supply; provided that, in such case, in accordance with Section 4.5 hereof at
least 50% of any Product planned by Pfizer to be manufactured during such
period shall be allocated to Schein.
Additionally, Schein will provide to Pfizer as of the date of the signing of
this Agreement and on or before the last day of each calendar quarter during
the term of this Agreement, a rolling forecast of the total quantity of
Product (including their distribution by dosage strength) to be manufactured
and delivered by Pfizer during each quarter for the two calendar quarters
beginning with the third calendar quarter of calendar year 2000. Except for
the Initial Purchase Order covering the first two calendar quarters of
calendar year 2000 (for which a forecast was
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not provided) and subject to Section 4.5 below, quantities of Product order
by Schein shall be 75%-125% of the quantity previously forecast for that
quarter by Schein, unless the parties otherwise agree. Forecasts provided by
Schein to Pfizer hereunder are for planning purposes only and shall be
non-binding.
4.3 Orders of Product will be in full lot size quantities as set forth
below:
5MMU - * vials
20MMU - * vials
Actual lot sizes upon delivery may vary from these numbers. Pfizer will promptly
notify Schein of the actual lot sizes at the time of delivery.
4.5 Production of Product by Pfizer will be split at least evenly between
Pfizer Product and Product to be sold by Schein so that at a minimum 50% of any
Product planned by Pfizer for manufacture shall be allocated to Schein.
SECTION 5.0 QUANTITIES AND PURCHASE ORDERS FOR RAW MATERIAL
5.1 Schein agrees to supply to Pfizer during the term of this Agreement on
the basis set forth herein, Pfizer's requirements for Raw Material for the
manufacture by Pfizer of Pfizer Product.
5.2 Schein agrees to supply to Pfizer an initial delivery of * kilograms
of Raw Material for the manufacture by Pfizer of Pfizer Product within thirty
(30) days of the date of this Agreement. Thereafter, within ten days of the
beginning of each calendar quarter Pfizer will place firm purchase orders for
Raw Material specifying quantities and delivery dates. Such further
deliveries will be made as determined according to Pfizer's actual quarterly
production
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* Material omitted pursuant to a request for confidential treatment. The
omitted material has been filed separately with the Securities and Exchange
Commission.
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requirements. Pfizer agrees that it will not have on hand at any time during
the term (including any extension periods) of this Agreement inventory of Raw
Material greater than * kilograms in excess of its actual quarterly
production requirements.
5.3 During any extension period of this Agreement as contemplated by Section
14.2.2. if:
(a) Schein is manufacturing penicillin G potassium for injection or is having
penicillin G manufactured by a third party on its behalf, then, in addition
to the other provisions set forth herein relating to the supply of Raw
Material to Pfizer, Schein shall not be obligated to supply to Pfizer more
than * kilograms per six-month extension period; or
(b) Schein is NEITHER manufacturing penicillin G potassium for injection NOR
having penicillin G potassium manufactured by a third party on its
behalf, then Schein will provide Pfizer with an accounting of its Raw
Material inventory and Pfizer will be entitled to order an amount of Raw
Material per quarter up to * of Schein's total Raw Material inventory
(so that *) unless demand for Pfizer Product exceeds that amount, in
which case the parties shall meet to discuss a reasonable amount that
Pfizer would be entitled to order in light of demand for Pfizer Product.
5.4 For the avoidance of doubt it is understood and agreed that if the Raw
Material is depleted or becomes not suitable for use in commercial
production, Schein is under no obligation
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* Material omitted pursuant to a request for confidential treatment. The
omitted material has been filed separately with the Securities and Exchange
Commission.
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to obtain additional raw material on behalf of Pfizer and no further
obligation to supply Raw Material to Pfizer.
SECTION 6.0 TERMS AND RISK OF LOSS
6.1 All freight charges for Product are to be paid by Schein from Pfizer's
Terre Haute, Indiana manufacturing facility to Schein's Eastern Distribution
Center in Brewster, NY. Prices are FOB Pfizer's plant, net 30 days from date of
invoice. Title to the Raw Material to be used for processing into Product to be
supplied to Schein will remain in Schein but risk of loss (due to casualty) will
be borne by Pfizer from the time of delivery of the Raw Material to Pfizer until
the time of delivery of the Product to Schein at Schein's Eastern Distribution
Center. In the event of such loss or damage Pfizer will compensate Schein at a
rate of * per BU of Raw Material, except in the event that such loss or damage
is due to the intentional misconduct of Pfizer in which case such compensation
will not be so limited.
6.2 At the end of any calendar year or upon termination or expiration of
this Agreement, if Pfizer has failed to meet the Minimum Yield for the lots
processed during that year, Pfizer shall compensate Schein at a rate of * per
BU of Raw Material for the Raw Material lost during that year with respect to
the difference between the actual Yield and the Minimum Yield.
6.3 Pfizer will provide Schein with a Certificate of Analysis for each lot
of Product delivered. This will include a statement of compliance with the
terms of Pfizer's New Drug Application for Pfizerpen(R), cGMP and all other
product related requirements as agreed to by the parties, and indicating that
the lot is therefore released for commercial distribution. The
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* Material omitted pursuant to a request for confidential treatment. The
omitted material has been filed separately with the Securities and Exchange
Commission.
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Certificate of Analysis shall include: Finished Product Name, Lot No. and
Expiry Date, Date of Manufacturing of bulk lot and lot number, and total
number of units released. Schein will provide Pfizer with a Certificate of
Analysis and manufacturing and storage records, as agreed to by the parties,
for each lot of Raw Material delivered.
6.4 Pfizer will use all reasonable efforts to deliver the quantities of
Product ordered within two weeks of delivery dates agreed upon by the parties.
Schein will use all reasonable efforts to deliver the quantities of Raw Material
ordered by Pfizer for manufacture of Pfizer Product Pfizer within 2 weeks of
delivery dates specified in the order.
6.5 Pfizer will invoice Schein for the Product within 30 days of date of
shipment. Schein will invoice Pfizer for the Raw Material ordered by Pfizer for
the manufacture by Pfizer of Pfizer Product within 30 days of date of shipment.
Schein's invoice will be payable by Pfizer within 30 days of date of invoice.
SECTION 7.0 INSPECTION AND REJECTION
7.1 The respective receiving party shall inspect Product and Raw
Material, as the case may be, within 60 days of receipt thereof at the
destination specified in the shipping instructions. Except as provided in
Section 7.2, if the shipment or any portion thereof fails to conform to the
warranties set forth in Section 9.1 or 9.2, except with respect to any latent
defect not identifiable with diligent investigation, the receiving party
shall, within 60 days of receipt thereof, notify the supplying party of its
intent to reject the Product or Raw Material and the reason for the intended
rejection, and afford the supplying party a reasonable opportunity to inspect
the Product or Raw Material. The receiving party shall cooperate with the
supplying party to determine whether rejection is necessary or justified. At
the receiving party's option, the supplying party shall give
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credit to the receiving party for the receiving party's price of a rejected
shipment, plus compensation at a rate of * per BU of Raw Material for the Raw
Material contained in such shipment of Product, or replace at the supplying
party's expense any non-conforming Product or Raw Material. The supplying
party shall give credit to the receiving party for the cost of shipping such
rejected shipment from the receiving party to the supplying party. The
supplying party shall make all reasonable efforts to complete the replacement
or adjustment promptly after the notification by the receiving party. The
receiving party shall not delay payment for Product or Raw Material pending
inspection; provided, however, that payment pending inspection shall not be
considered acceptance of Product of Raw Material by the receiving party.
7.2 Pfizer shall have no obligation to credit or reimburse Schein for
shipments of Product incorporating Raw Material that fails to conform to the
warranties set forth in Section 9.2.
7.3 If the parties cannot agree, after a period of 60 days following the
receiving party's notice of its intent to reject pursuant to Section 7.1,
whether rejection is necessary or justified, then the Vice President of
Regulatory Compliance of Schein and the Senior Vice President - Global
Manufacturing of Pfizer shall mutually determine in good faith whether the
rejected Product or Raw Material was in conformance with the warranties set
forth in Section 9.1 or 9.2.
SECTION 8.0 QUALITY CONTROL
8.1 Each party will, as required, maintain a quality control program
(including, without limitation, exception investigation policies and
procedures), consistent with CGMPs as related to this Agreement, as found at
21 CFR Part 211, and all subsequent additions and revisions thereto.
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* Material omitted pursuant to a request for confidential treatment. The
omitted material has been filed separately with the Securities and Exchange
Commission.
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8.2 Each party will, as required, obtain and maintain the equipment
required to fulfill its obligations under this Agreement consistently with
CGMPs.
8.3 All Product supplied hereunder will be manufactured in accordance with
the procedures described in Pfizer's New Drug Application ("NDA") for
Pfizerpen(R), including supplemental NDAs for Pfizerpen(R) and all CGMPs or
other applicable federal or state regulations in effect at the time of
manufacture. Pfizer will notify Schein in advance of submitting to the FDA a
change in the "Chemistry, Manufacturing and Controls" section of the Pfizerpen
NDA.
SECTION 9.0 WARRANTIES, REMEDIES AND LIMITATIONS
9.1 Except to the extent that the Raw Material delivered by Schein fails
to conform to the warranties set forth in Section 9.2 hereof, Pfizer warrants
that the Product delivered hereunder (i) will be free from liens or claims of
third parties; (ii) will conform to the specifications set forth in Exhibit
2; (iii) will conform to the Certificate of Analysis supplied to Schein by
Pfizer; and (iv) will not be adulterated or misbranded within the meaning of
the Federal Food, Drug and Cosmetic Act. Nothing herein imposes any
obligation on Pfizer with respect to claims for damages for use of Product
sold by Schein from causes other than those expressly set forth hereunder.
9.2 Schein warrants that the Raw Material delivered hereunder (i) will be
free from liens or claims of third parties with respect to Raw Material sold
to Pfizer for manufacture of Pfizer Product; (ii) will conform to the
specifications set forth in Exhibit 1; (iii) will conform to the Certificate
of Analysis supplied to Schein by Pfizer; (iv) will not be adulterated or
misbranded within the meaning of the Federal Food, Drug and Cosmetic Act; and
(v) was
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manufactured by * in its * manufacturing facility and will have been stored
at all times under the recommended storage conditions. Nothing herein imposes
any obligation on Schein with respect to claims for damages for use of Pfizer
Product from causes other than those expressly set forth hereunder.
9.3 THE WARRANTIES SET FORTH IN SECTION 9.1 AND 9.2 ARE EXCLUSIVE AND
ARE GIVEN AND ACCEPTED IN LIEU OF ANY AND ALL OTHER WARRANTIES, EXPRESSED OR
IMPLIED, INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF
MERCHANTABILITY OR SUITABILITY FOR PARTICULAR PURPOSE. EXCEPT AS PROVIDED IN
SECTIN 13.2 AND 13.3, THE REMEDIES AFFORDED TO SCHEIN FOR ANY BREACH OF
WARRANTY WILL BE LIMITED TO THOSE SET FORTH IN SECTION 7.1 TO THE EXCLUSION
OF ANY AND ALL OTHER REMEDIES. NEITHER PARTY TO THIS AGREEMENT WILL BE
ENTITLED TO INCIDENTAL OR CONSEQUENTIAL DAMAGES AS A RESULT OF THE BREACH OF
THIS AGREEMENT BY THE OTHER. NO AGREEMENT VARYING OR EXTENDING THE FOREGOING
WARRANTIES, REMEDIES OR THIS LIMITATION WILL BE BINDING ON EITHER PARTY
UNLESS IN WRITING AND AS PRESCRIBED BY SECTION 15.5.
SECTION 10.0 SCHEIN'S ACCESS TO PFIZER'S FACILITY
Pfizer will permit Schein to have access to Pfizer's manufacturing facility
on a confidential basis and upon reasonable notice at any time during the
manufacture of the Product.
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* Material omitted pursuant to a request for confidential treatment. The
omitted material has been filed separately with the Securities and Exchange
Commission.
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SECTION 11.0 EXCHANGE OF OTHER INFORMATION
The appropriate technical representatives of the parties will meet as
required to discuss supply issues. The parties will also meet as required to
discuss regulatory compliance and quality control matters in an effort to begin
the commercial supply of the Product expeditiously. Each party shall bear its
own expenses relating to such meetings. Pfizer will provide Schein, upon
Schein's request, with copies of Pfizer's Annual Product Review covering the
Products to be sold by Schein, which will include complaint and stability
analysis.
SECTION 12.0 CONFIDENTIAL INFORMATION
12.1 Each of Pfizer and Schein agrees to keep and will keep each item of
the other's confidential information disclosed hereunder secret for a period of
ten (10) years from the date hereof and shall not disclose the same either fully
or partially to any third party, without the prior written consent of the
disclosing party, except those items of the information:
(a) which at the time they come to the knowledge of
the receiving party are publicly known, or
(b) which after they come to the knowledge of the receiving party
become publicly known through no fault of the receiving party but
only after and to the extent that they become publicly known, or
(c) which the receiving party can show were received in a legal way
from a third party being under no obligation of confidence to the
disclosing party, or
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(d) which were independently developed by the receiving party without
access to the disclosing party's confidential information as can
be demonstrated by contemporaneous written records.
12.2 Each of Schein and Pfizer furthermore agrees not to use and will not
use the other's confidential information which each of them is obligated to
maintain in secret according to 12.1 above for any purpose other than the
exercise of their rights hereunder.
SECTION 13.0 COMPLAINTS AND INDEMNITY
13.1 Complaints
13.1.1 Subject to Sections 13.1.3 and 13.1.41 and 13.3, Schein will be
responsible for handling any customer and regulatory complaints with respect to
the Products sold by Schein. Pfizer will promptly notify Schein of any complaint
it receives with respect to Products sold by Schein and will provide efficient
cooperation to Schein in connection with the handling of any such complaints.
13.1.2 Subject to Section 13.2, Pfizer will be for responsible for
handling any customer and regulatory complaints with respect to Pfizer
Product. Schein will promptly notify Pfizer of any complaint it receives with
respect to Pfizer Product or Product sold by Schein and will provide
efficient cooperation to Pfizer in connection with the handling of any such
complaints.
13.1.3 With respect to any Product supplied to Schein by Pfizer
hereunder, Pfizer will be responsible for the investigation of any Product
complaints arising from the manufacturing, processing, packaging or labeling
upon notification by Schein.
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13.1.4 Pfizer acknowledges that, pursuant to its obligations as holder
of the NDA for Pfizerpen(R), Pfizer shall have the responsibility to report to
the U.S Food and Drug Administration ("FDA") any adverse drug events ("ADEs", as
defined by relevant FDA regulations) as required by law. Each of the parties
agrees to furnish the other party, as provided in 13.1.5, with information
pertaining to any ADE occurring in the United States of which it becomes aware.
13.1.5 In the case of any serious ADE, the party in question shall
notify the other party within three (3) working days of knowledge of the ADE.
All other ADEs shall be reported by the party in question form time to time, but
not less frequently than monthly in the same manner.
Notifications will be sent to:
Pfizer Inc.
Vice President, Worldwide Safety
000 Xxxx 00xx Xxxxxx
Xxx Xxxx, XX 00000
Schein Pharmaceutical, Inc.
Director of Regulatory Affairs/Professional Services
X.X.Xxx 0000
Xxxxxx Xxxx, XX 00000
13.1.6. Each party shall maintain, in accordance with its own
customary practice, appropriate detailed records of all ADE reports which
have been submitted to the other party. Further, in the event that either
party shall receive a request for a more detailed investigation by the FDA
regarding an ADE involving Product, the other party shall cooperate and
assist the party receiving the request with respect to such investigation.
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13.1.7 Each party shall promptly advise the other of any significant
safety or toxicity developments of which either of them becomes aware relating
specifically to the Product or intermediates or other ingredients or processes
used in the manufacture of Product.
13.2 Schein Indemnity
13.2.1 Schein will indemnify Pfizer and its officers, directors,
agents and employees against, and will assume the defense of (i) any and all
product liability claims for damages for human bodily injury and/or death
resulting from the ingestion or use of Product sold by Schein or relating to any
recall of Product sold by Schein, except to the extent that such damages are the
result of Pfizer's negligence in manufacturing Product or any breach of the
terms of Section 8.0 or 9.1 hereof by Pfizer; and (ii) any and all product
liability claims for damages for human bodily injury and/or death resulting from
the ingestion or use of Pfizer Product or relating to any recall of Pfizer
Product, to the extent that such damages or expenses are attributable to the
negligence of Schein in supplying Raw Material hereunder or the breach of the
terms of Section 8.0 or 9.2 hereof by Schein.
13.2.2 If any claims are made against Pfizer as to which the
indemnification set forth in Section 13.2 applies, Pfizer, as soon as
reasonably practicable, will inform Schein thereof. Subject to Pfizer's
obligation to indemnify Schein pursuant to Section 13.3, Schein and/or its
insurers will assume the defense of any such claims for damages for human
bodily injury and/or death resulting from the ingestion or use of Pfizer
Product or Product sold by Schein or relating to any recall of Pfizer Product
or Product sold by Schein including, without limitation, the right to settle
such claims at the sole option of Schein or its insurers. Pfizer will
cooperate with Schein and its insurers in the disposition of any such
matters. Pfizer shall have the right to participate at its own expense in the
defense of any such claim.
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13.3 Pfizer Indemnity
13.3.1 Pfizer will indemnify Schein and its officers, directors,
agents and employees against and will assume the defense of (i) any and all
product liability claims for damages for human bodily injury and/or death
resulting from the ingestion or use of Pfizer Product relating to any recall of
Pfizer Product, except to the extent that such damages are the result of
Schein's negligence in supplying Raw Material or any breach of the terms of
Section 8.0 or 9.2 hereof by Schein; and (ii) any and all product liability
claims for damages for human bodily injury and/or death resulting from the
ingestion or use of Product sold by Schein or relating to any recall of Product
sold by Schein, incurred by Schein to the extent that such damages or expenses
are attributable to the negligence of Pfizer in manufacturing Product hereunder
or any breach of the terms of Section 8.0 or 9.1 hereof by Pfizer.
13.3.2 If any claims are made against Schein as to which the
indemnification set forth in Section 13.3 applies, Schein, as soon as
reasonably practicable, will inform Pfizer thereof. Subject to Schein's
obligation to indemnify Pfizer pursuant to Section 13.2, Pfizer and/or its
insurers will assume the defense of any such claims for damages for human
bodily injury and/or death resulting from the ingestion or use of Product
sold by Schein or relating to any recall of Products sold by Schein
including, without limitation, the right to settle such claims at the sole
option of Pfizer or its insurers. Schein will cooperate with Pfizer and its
insurers in the disposition of any such matters. Schein shall have the right
to participate at its own expense in the defense of any such claim.
SECTION 14.0 TERM AND TERMINATION
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14.1 The initial term of this Agreement will be the one (1) year period
beginning with the date of this Agreement. The term may be extended by written
agreement of the parties at least 90 days prior to expiration of the initial
period or any extensions thereto.
14.2 It is understood that by the time of the expiration of this Agreement,
Schein intends to re-establish its own manufacturing site for Product and that
both parties intend to obtain a new FDA-approved source for Raw Material. Given
the uncertainty of these efforts, however, the following additional options to
extend the initial term of the Agreement are provided:
14.2.1 Schein shall have the option to extend this Agreement and all
its provisions for up to two additional six-month extension periods by giving
Pfizer written notice of such extension at least ninety (90) days prior to
expiration of the initial term or the first extension thereto.
14.2.2 Pfizer shall have the option to extend this Agreement and all
its provisions relating to the supply by Schein of Pfizer's requirements for Raw
Material for the manufacture by Pfizer of Pfizer Product for up to four
additional six-month extension periods by giving Schein written notice at least
sixty (60) days prior to the expiration of the initial term of any extensions
thereto.
14.3 Either party will have the right to terminate this Agreement if the
other party fails to remedy any material breach of this Agreement within sixty
days of written notice of such breach.
14.4 The terms and provisions of Section 6.1, 6.2, 7.1, 7.2, 7.3, 12.0 and
13.0 shall survive the term and termination of this Agreement.
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SECTION 15.0 MISCELLANEOUS
15.1 Force Majeure - Except as otherwise specifically provided herein,
neither party will be liable for failure of or delay in performing obligations
set forth in this Agreement, and neither party will be deemed in breach of its
obligations, to the extent such failure or delay is due to natural disasters or
any causes reasonably beyond the control of such party.
15.2 Assignment - This Agreement is not assignable by either party without
the prior consent of the other, except that either party may assign this
Agreement, in whole or in part, to any Affiliate of such party or to the
successor (including the surviving company in any consolidation or merger) or
assignee of all or substantially all of its pharmaceutical business including,
with respect to Schein, a sale of all or substantially all of its sterile
pharmaceutical business, excluding its branded pharmaceutical business.
15.3 Governing Law - This Agreement will be governed by the laws of the
State of New York.
15.4 Notices - Any notice required under this Agreement will be in writing
and delivered personally or sent by registered mail, postage prepaid, or by fax
(confirmed by such registered mail) addressed as follows:
Schein Pharmaceutical, Inc.
000 Xxxxxx Xxxxx
Xxxxxxx Xxxx, Xxx Xxxxxx 00000
Attn: President (with a copy to General Counsel)
Fax No.: 000-000-0000
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Pfizer Inc
000 Xxxx 00xx Xxxxxx
Xxx Xxxx, Xxx Xxxx, XXX 00000
Attn: General Counsel
Fax No.: (000) 000-0000
(with a copy to: Vice President, Pfizer Global
Manufacturing)
All notices will be deemed to be effective on the date of delivery if delivered
personally or on the date of transmittal, in the case of notice sent by fax, or
on the date of mailing, as applicable. In case any party changes its address at
which notice is to be received, notice of such change will be given without
delay to the other party in the manner provided therein.
15.5 Entire Agreement - This Agreement, including its Exhibits, sets
forth the entire agreement and understanding between the parties hereto as to
the subject matter hereof and has priority over all documents, verbal
consents or standings made by Pfizer and Schein before the conclusion of this
Agreement with respect to the subject matter hereof; none of the terms of
this Agreement may be amended or modified except in writing signed by the
parties hereto.
15.6 Waivers - A waiver by either Party of any term or condition of this
Agreement in any one instance will not be deemed or construed to be a waiver of
such term or condition for any similar instance in the future or of any
subsequent breach hereof. All rights, remedies, undertakings, obligations and
agreements contained in this Agreement will be cumulative and none of them will
be a limitation of any other remedy, right, undertaking, obligation or
agreement.
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15.7 Headings - Headings in this Agreement are included herein for ease of
reference only and will have no legal effect.
15.8 No Joint Venture - Nothing herein creates any association,
partnership, joint venture or the relations of principal and agent between the
parties, it being understood that the parties are acting as independent
contractors in relation to each other, and neither party has authority to bind
the other or the other's representatives in any way.
15.9 Severability - The invalidity of unenforceability of any provision of
this Agreement will in no way affect the validity or enforceability of any other
provision of this Agreement.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed as of the date first written above their duly authorized
representatives.
PFIZER INC SCHEIN PHARMACEUTICAL, INC.
BY: /s/ XX Xxxxxxxx BY: /s/ Xxxxxxx Xxxxxxx
----------------------------- -----------------------------
NAME: XX Xxxxxxxx Name: Xxxxxxx Xxxxxxx
----------------------------- -----------------------------
TITLE: SR VP-Manufacturing TITLE: President and COO
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EXHIBIT 1
RAW MATERIAL SPECIFICATIONS
* (3 pages omitted) *
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* Material omitted pursuant to a request for confidential treatment. The
omitted material has been filed separately with the Securities and Exchange
Commission.
22
EXHIBIT 2
PRODUCT SPECIFICATIONS
* (4 pages omitted) *
----------
* Material omitted pursuant to a request for confidential treatment. The
omitted material has been filed separately with the Securities and Exchange
Commission.
23
EXHIBIT 3
PRICES FOR MANUFACTURE OF PRODUCTS
DOSAGE STRENGTH PRICE ($U.S./VIAL)
--------------- ------------------
5 million units (MMU) per vial *
20 million units (MMU) per vial *
----------
* Material omitted pursuant to a request for confidential treatment. The
omitted material has been filed separately with the Securities and Exchange
Commission.
