EXHIBIT 10.29
[CONFIDENTIAL TREATMENT REQUETED. CONFIDENTIAL PORTIONS OF THIS AGREEMENT HAVE
BEEN REDACTED AND HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.]
MANUFACTURING & DISTRIBUTION AGREEMENT
AGREEMENT, made as of this 27th day of February, 1996, by and between
GENSIA LABORATORIES, LTD., a corporation organized under the laws of Delaware,
having its principal place of business at 00 Xxxxxx, Xxxxxx, Xxxxxxxxxx
00000-0000 ("GENSIA"), and OHMEDA PPD, a corporation organized under the laws of
Delaware, having its principal place of business at 000 Xxxxx Xxxx, Xxxxxxx
Xxxxxx, Xxx Xxxxxx 00000-0000 ("OHMEDA PPD").
WITNESSETH:
WHEREAS, GENSIA manufactures, packages, sells, markets and distributes a
broad range of complimentary anesthesia related hospital products;
WHEREAS, OHMEDA PPD manufactures, markets sells and distributes a range of
anesthesia related intravenous and inhalation products;
WHEREAS, both GENSIA and OHMEDA PPD believe that each of them and their
respective customers would benefit by formation of a collaborative sales,
marketing and distribution effort;
WHEREAS, OHMEDA PPD desires to distribute GENSIA manufactured products
under an OHMEDA PPD label and include such products in an OHMEDA PPD capitation
program;
WHEREAS, GENSIA desires and has the ability to manufacture and supply such
Products for OHMEDA PPD; and
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NOW, THEREFORE, in consideration of the mutual premises contained in this
Agreement, and for other good and valuable consideration the parties hereto
agree to the following:
1. DEFINITIONS.
The following terms for the purpose of this Agreement shall have the
following respective meanings:
1.1 "Affiliate" shall mean, with respect to either party, all entities
which, directly or indirectly, are controlled by, control or under the common
control with such party. For purposes of this definition, the word "control"
shall mean ownership of more than fifty per cent (50%) of the voting shares or
interest of an entity.
1.2 "ANDA" shall mean the Abbreviated New Drug Application(s) for any of
the Product(s) which have been submitted to the FDA by GENSIA including any
amendments or supplements thereto.
1.3 "Annual Period" shall mean each twelve (12) month period during the
term of this Agreement commencing on January 1, 1996.
1.4 "FDA" shall mean the United States Food and Drug Administration.
1.5 "FIFO" shall mean the first in, first out method of inventory flows
and valuation.
1.6 "Gross Margin" shall mean the difference between Net Sales of Products
and the aggregate Transfer Prices for Products.
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1.7 "Materials" shall, mean all active and inactive raw materials used in
the formulation of Products, as well as all packaging components, labels and
labelling necessary for the manufacture of the Products as finished goods.
1.8 "Net Sales" shall mean actual invoiced sales of the Products by OHMEDA
PPD to third parties less the following:
(i) allowances for discounts or rebates (including, subject to
Section 15, capitation discounts or rebates), chargebacks, or buying group
administration fees reasonably allocable to such sales of Products;
(ii) returns, recalls, credits or allowances, if any, given or made;
(iii) sales, use, value-added or other excise taxes, if any, imposed
on the sale by any governmental entity;
(iv) freight and insurance costs incurred in transporting Products
to OHMEDA PPD's distribution center in Memphis, Tennessee or to such other
distribution center in the Territory as may be designated by OHMEDA PPD;
and
(v) management fees paid to Xxxxxx Healthcare Corporation by OHMEDA
PPD in connection with the sale of Products in the Territory; provided
that OHMEDA PPD shall obtain GENSIA's consent prior to the inclusion of
any portion of the management fees as a deduction to Net Sales herein.
1.9 "Per Unit Materials Cost" shall be the summation of the quantity
required per finished shelf keeping unit of each input Material as outlined in
the applicable Product xxxx of
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material times the per unit invoiced acquisition cost of such Material as
accounted for on a FIFO basis.
1.10 "Products" shall mean the injectable pharmaceutical products set
forth in Exhibit A that are manufactured by GENSIA or its permitted contract
manufacturers in finished presentation form with the OHMEDA PPD label.
1.11 "Specifications" shall mean the specifications for each of the
Products set forth in Exhibit B.
1.12 "Territory" shall mean the United States of America, its territories
and possessions and the Commonwealth of Puerto Rico.
2. SUPPLY OF PRODUCTS.
2.1 SUPPLY. During the term of this Agreement, GENSIA agrees to supply to
OHMEDA PPD those quantities of Products ordered by OHMEDA PPD for distribution
in the Territory. Subject to the terms and conditions set forth herein, GENSIA
shall provide such manufacturing facilities, equipment, and services as maybe
required to meet its supply obligations hereunder.
2.2 SUPPLY OF MATERIALS. GENSIA shall supply all Materials necessary for
the manufacture of the Products unless otherwise mutually agreed.
2.3 FORECASTS AND ORDERS. OHMEDA PPD agrees to forecast demand and issue
purchase orders for Products in accordance with the procedures set forth under
Section 2.4. GENSIA shall use its best efforts to deliver Product ordered for
the first two (2) months of this
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Agreement on the delivery date requested by OHMEDA PPD. Thereafter, GENSIA shall
deliver Products sixty (60) days from the initial order in accordance with the
demand schedule submitted by OHMEDA PPD in accordance with Section 2.4. Products
shall be ordered in minimum lot sizes for each Product presentation as set forth
in Exhibit C.
2.4 DEMAND SCHEDULES. Commencing January 1, 1996, OHMEDA PPD shall provide
GENSIA monthly with a twelve (12) month rolling forecast ("Demand Schedule") for
each presentation of the Products. The first three (3) months of the first two
Demand Schedules shall constitute firm OHMEDA PPD purchase orders. Commencing
with the third Demand Schedule, the first two (2) months of the Demand Schedule
shall reflect OHMEDA PPD's firm purchase orders communicated by previous Demand
Schedules and a firm OHMEDA PPD purchase order for the next succeeding (third)
month. OHMEDA PPD shall be obligated to purchase 100% of each issued purchase
order. The remainder of the Demand Schedule is for planning purposes only. An
illustration of a Demand Schedule submitted at the beginning of a hypothetical
month of April is as follows:
Example of submission for beginning of April
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Presentation 1 Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar
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Xxxx Xxxx Xxxx Xxxx Xxxx Xxxx Xxxx Xxxx Xxxx Xxxx Xxxx Xxxx
PO# PO# PO# Fcst Fcst Fcst Fcst Fcst Fcst Fcst Fcst Fcst
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Date Date Date
Reqd Reqd Reqd
=========================================================================================
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=========================================================================================
Presentation 2 Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar
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Xxxx Xxxx Xxxx Xxxx Xxxx Xxxx Xxxx Xxxx Xxxx Xxxx Xxxx Xxxx
PO# PO# PO# Fcst Fcst Fcst Fcst Fcst Fcst Fcst Fcst Fcst
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Date Date Date
Reqd Reqd Reqd
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FROM PREVIOUS NEW NEW FORECAST ---------->
SUBMISSION PURCH
ORDER
Except for orders appearing in month one (1) of a Demand Schedule, GENSIA will
make reasonable efforts to reschedule firm orders to accommodate changing demand
patterns within the market place.
2.5 ORDERS IN EXCESS OF FORECAST. GENSIA shall make reasonable efforts to
deliver quantities of Products that are ordered by OHMEDA PPD and that are in
excess of OHMEDA PPD's firm orders made pursuant to Section 2.4.
2.6 DELIVERY TERMS. GENSIA agrees to deliver the Products to OHMEDA PPD
F.O.B. GENSIA's plant in Irvine, California. Products shall be shipped by GENSIA
according to OHMEDA PPD's instructions.
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3. WARRANTY, MANUFACTURING STANDARD AND QUALITY ASSURANCE.
3.1 PRODUCT WARRANTY.
Product supplied by GENSIA shall at the time of delivery have a remaining
shelf life equal to or greater than the maximum shelf life for the Product in
the approved ANDA less three (3) months. GENSIA warrants that Product delivered
to OHMEDA PPD hereunder, shall at the time of delivery until the expiration
thereof as shown by the expiration date on the Product package (the "Warranty
Period"): (i) be free from defects in Materials and manufacture and shall
conform to the Specifications therefor, as such Specifications are set forth in
the applicable ANDA therefor, (ii) conform to all additional Product
specifications mutually agreed upon, and (iii) have been manufactured in
accordance with current Good Manufacturing Practices as listed in 21 CFR 211 and
shall conform in all material respects to all applicable regulations and all
other requirements of applicable regulatory authorities throughout the
Territory. GENSIA further warrants and guarantees that, as of the date of each
shipment hereunder to OHMEDA PPD of any Product subject to the provisions of the
United States Food and Drug and Cosmetic Act or any applicable statute or
regulation in the Territory, such Product shall not, when shipped, be
adulterated or misbranded within the meaning of any applicable law, or be an
article which may not, under the provisions of applicable law, be sold in the
Territory. The warranties contained herein shall not apply to any Product which
(i) has been tampered with or otherwise altered other than by GENSIA or
supplier; (ii) has been subject to misuse, negligence or accident other than by
GENSIA or its supplier; or (iii) has been stored, handled or used in a manner
contrary to FDA requirements or (iv) has expired its stated shelf life (subject
to OHMEDA PPD's right to reject Product that does not meet the shelf life
requirements set forth above).
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EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, GENSIA MAKES NO OTHER
WARRANTIES EITHER EXPRESS, IMPLIED OR OTHERWISE, AND SPECIFICALLY DISCLAIMS ANY
IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
3.2 PRODUCT INSPECTIONS. If within forty-five (45) days after receipt of
Product by OHMEDA PPD at its facility, OHMEDA PPD notifies GENSIA in writing
that the Product does not meet the Specifications as determined by OHMEDA PPD's
testing and inspection of the Product, GENSIA shall replace the Product at no
charge within thirty (30) days and shall pay for shipping charges to deliver
replacement Product to OHMEDA PPD. Non-conforming Product shall, upon mutual
agreement by the parties and at GENSIA's sole expense, either (i) be returned to
GENSIA within a reasonable period of time or (ii) be destroyed by OHMEDA PPD. If
requested by OHMEDA PPD, GENSIA shall assist OHMEDA PPD in the transfer of the
required analytical test methods to monitor the quality of the Products. If
required, GENSIA will provide all required analytical methodology, the
associated documentation and required standards. The warranties given by GENSIA
in this Agreement shall survive any failure to reject by OHMEDA PPD pursuant to
this Section 3.2
3.3 DISPUTES WITH RESPECT TO REJECTION. If GENSIA disputes OHMEDA PPD's
right to reject all or part of any shipment of the Products as set forth in
Section 3.2 hereof, and such dispute is not resolved by mutual agreement between
the parties within sixty (60) days of OHMEDA PPD's notice of rejection, such
dispute shall be resolved by an independent FDA approved testing organization
mutually agreed upon by the parties, the appointment of which shall not be
unreasonably withheld or delayed by either party. The determination of such
testing entity with respect to all or part of any shipment of the Products shall
be final and binding upon
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the parties, but only as to the reasons given by OHMEDA PPD in rejecting the
shipment or portion thereof and shall have no effect on any matter for which
said entity did not render a determination. The fees and expenses of the third
party making the determination shall be paid by the party against which the
determination is made.
3.4 MASTER FORMULA. The composition of Products will be as stated in the
applicable approved Product ANDA.
3.5 MANUFACTURING AND PACKAGING INSTRUCTIONS AND PROCEDURES. Products will
be manufactured and packaged by GENSIA or by permissible third-party
manufacturers in accordance with current Good Manufacturing Practices ("GMP") as
promulgated by the FDA and pursuant to the Drug Master File ("DMF") and/or the
applicable approved Product ANDA.
3.6 CONTAINERS AND PACKAGING. GENSIA shall supply the vials, stoppers,
seals, labelling and packaging necessary to manufacture the Products in
accordance with the Products Specifications.
3.7 LABELLING. All labels for Products shall use the OHMEDA PPD name and
NDC number. GENSIA shall be permitted to use such labels only on Products
delivered to OHMEDA PPD hereunder. OHMEDA PPD shall provide in a timely manner
the camera ready art work for labelling for the containers, package inserts and
packaging for each dosage unit of Product, as well as for the shipping
containers in the form specified by GENSIA at OHMEDA PPD's cost. OHMEDA PPD
shall have approved all such labelling in writing in advance of initial
printing. Unless otherwise agreed labelling approved by OHMEDA PPD shall be the
only labelling used by GENSIA for Products, provided that any labels and package
inserts shall be consistent with FDA and GENSIA's requirements with regard to
physical dimensions and specifications relating
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to the methods of handling and affixing on container. Any label art work
preparation and setup charge shall be billed to OHMEDA PPD on a pass through
cost basis. In addition, all costs associated with any labelling changes
required by OHMEDA PPD or required by the FDA, including the costs associated
with any labelling or packaging rendered obsolete by such changes, shall be
borne by OHMEDA PPD. During the initial six-month (6) period of this Agreement,
if circumstances warrant, and if approved by OHMEDA, GENSIA may supply Products
for OHMEDA PPD with the current GENSIA label, under the terms and conditions
herein, until the OHMEDA PPD labeled Product is ready. Thereafter, GENSIA may
supply a Product with a GENSIA label only if no OHMEDA PPD labeled Product is
available and OHMEDA consents to such supply.
3.8 CHANGE CONTROL. GENSIA will notify OHMEDA PPD in writing of any
proposed change to ingredients or components of the Products, process
specifications and/or controls, as well as equipment, facilities, or third party
contractors utilized for the manufacturing and/or packaging of Products if the
proposed change requires FDA notification. Any such change must be agreed upon
and approved in writing by OHMEDA PPD prior to implementation or submission to
regulatory authorities for approval. Subject to Section 4.3, changes in the
prescribing information (package insert) and labeling shall be the
responsibility of GENSIA to implement. Notwithstanding the foregoing, in the
event that any proposed change to ingredients or components of the Products,
process specifications and/or controls, equipment; facilities or third party
packagers utilized for the manufacturing and/or packaging of Products is
required by any governmental authority, GENSIA shall deliver written notice to
OHMEDA PPD specifying such change required by such governmental authority. Such
change shall be deemed to have been accepted by OHMEDA PPD unless within thirty
(30) days after OHMEDA PPD's receipt
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of such notice, it shall notify GENSIA in writing that it cannot, in good faith,
agree to such change. If OHMEDA PPD determines that such change to ingredients
or components of the Products, process specifications and/or controls,
equipment, facilities or third party packagers utilized for the manufacturing
and/or packaging of Products required by such governmental authority cannot be
so agreed to, then OHMEDA PPD and GENSIA shall negotiate, in good faith, an
amendment to the Agreement deleting the Product to which the proposed changes
are applicable and altering or adding such other terms as may be just and
equitable in the circumstances.
3.9 BATCH RECORDS. Records which include the information relating to the
manufacturing, packaging and quality operation for each lot of Products shall be
prepared by GENSIA for each lot at the time at which such operations occur. The
records shall include, but are not limited to, the following documentation:
manufacturing, raw materials and components charge-in records; mixing and
fillings records; packaging component charge-in records; packaging records;
container and component traceability records; in-process and final laboratory
testing results; in-process and final product physical inspection results; yield
reconciliation for bulk and finished product; label samples; labeling control
records; as well as documentation listing any deviations and/or excursions from
approved procedure (as well as the GENSIA investigation and corrective actions)
incurred during the processing and packaging of the lot. The original documents
for each lot may be reviewed by OHMEDA PPD at its request when auditing the
sites of manufacture of Products.
3.10 BATCH DOCUMENTS TO BE INCLUDED WITH EACH SHIPMENT OF PRODUCT TO
OHMEDA PPD. The following outlines the minimum batch documentation required to
be included with each lot of Product shipped to OHMEDA PPD:
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o Packaging Xxxx of Materials
o Copies of Certificate of Analysis for each lot.
The certificate of analysis, signed by the responsible quality official, must
include the numerical results for each test (chemical, microbiological and
bacteriological) performed to assure results are in compliance with Product
Specifications, the date of manufacture and expiration date of the Product, as
well as a statement that subject lot was produced in accordance to the
applicable ANDA and in compliance with all applicable GMP requirements.
3.11 RETENTION SAMPLES. GENSIA is responsible for storing and maintaining
retention samples of finished Products from each lot supplied to OHMEDA PPD to
meet regulatory requirements. GENSIA is responsible for storing and maintaining
retention samples of each lot of raw material utilized in the manufacture of
Products in accordance with all regulatory and FDA GMP.
3.12 PRODUCT COMPLAINTS. GENSIA shall assist OHMEDA PPD in investigating
product complaints by analyzing Product and Materials to determine the cause, if
any, of an alleged Product manufacturing defect or failure. GENSIA shall also
assist OHMEDA PPD in the investigation of any adverse drug events when such
adverse events are believed to be attributable to Products. GENSIA shall
diligently work to provide a written report of its determination within thirty
(30) days from receipt of OHMEDA PPD's written request and samples of the
involved Products. OHMEDA PPD shall be responsible to ensure that GENSIA
receives samples of the Products to be investigated. In the event that OHMEDA
PPD determines that any reasonable additional physical, chemical, biological, or
other evaluation should be conducted by GENSIA in relation to an adverse drug
event or product complaint, OHMEDA PPD shall so advise GENSIA. GENSIA shall
conduct the necessary evaluations and advise
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OHMEDA PPD of the results. OHMEDA PPD shall correspond with complainants on all
product complaints associated with Products.
3.13 PROCESS VALIDATION. GENSIA shall validate, at its cost, all
processes, equipment, utilities, facilities and computers utilized in the
manufacture, packaging, storage, testing and release of Products for regulatory
submissions and commercial sale in conformance with all current FDA and other
applicable regulatory authority guidelines and regulations. GENSIA shall be
responsible for and shall ensure that all validated systems are maintained
according to FDA guidelines and that all required periodic revalidations are
performed according to FDA guidelines. OHMEDA PPD shall reserve the right to
review all Master Validation Plans and/or the corresponding protocols if no
Master Plan exists prior to execution of such validation. OHMEDA PPD reserves
the right to review the results of all related validation studies.
3.14 REGULATORY VISITS. In the event of an inspection by the FDA or any
applicable regulatory authority which results in a concern by the FDA or
applicable regulatory authority specifically related to Products, then OHMEDA
PPD through its designee, the OHMEDA PPD Vice President of Quality, will be
notified as soon as possible of such concern. GENSIA shall cooperate in
resolving the matter with FDA or the applicable regulatory authority.
3.15 CHANGES TO SPECIFICATIONS. Specifications of the Products shall not
be supplemented, modified or amended in any respect without the prior written
agreement of the parties hereto. In the event that OHMEDA PPD desires any change
to the Specifications of the Products, OHMEDA PPD shall deliver written notice
to GENSIA specifying such change desired by OHMEDA PPD and GENSIA shall respond
to any such notice within thirty (30) days after GENSIA's receipt thereof. In
the event that any change to the Specifications is required by
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any governmental authority, GENSIA shall deliver written notice to OHMEDA PPD
specifying such change required by such governmental authority. Such change
shall be deemed to have been accepted by OHMEDA PPD unless within thirty (30)
days after OHMEDA PPD's receipt of such notice, it shall notify GENSIA in
writing that it cannot, in good faith, agree to such change. If OHMEDA PPD
determines that such change in the specifications required by such governmental
authority cannot be so agreed to, then OHMEDA PPD and GENSIA shall negotiate, in
good faith, an amendment to the Agreement deleting the Product to which the
Specification sought to be changed is applicable and altering or adding such
other terms as may be just and equitable in the circumstances.
3.16 ON-GOING STUDIES. GENSIA shall be responsible for the generation of
all data and associated reports for all stability studies in support of the
currently approved ANDA in accordance with the on-going marketed protocol for
each of the Products.
3.17 AUDITS. OHMEDA PPD shall have the right, at reasonable intervals, as
circumstances require, and on reasonable prior notice (which notice shall be
waived if circumstances warrant), to inspect those sections of the
manufacturing, packaging, laboratory and warehousing facilities utilized in the
manufacture, packaging, storage, testing, shipping or receiving of Products.
Such inspections may include GMP inspections, systems audits and physical
inventories, of the excipient and active ingredients, the work in process and
finished goods of Products as well as all batch records as set forth in Section
3.9. The frequency and extent of inspections shall be determined by mutual
agreement of GENSIA and OHMEDA PPD. OHMEDA PPD shall have the right to station
quality personnel at the manufacturing facilities for the Products on
substantially a full-time basis, when there is work being conducted that
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relates to the Products, for the purpose of monitoring the production, and
quality assurance activities and reviewing batch records with respect to the
Products.
3.18 THIRD-PARTY MANUFACTURERS. To the extent that GENSIA, uses a
third-party manufacturer for any of the Products, then GENSIA shall monitor and
ensure that such third-party manufacturer is in compliance with the
manufacturing standards set forth in this Agreement. Subsequent to the execution
of this Agreement, GENSIA shall comply with the provisions of Section 3.8 prior
to any additional use of third-party manufacturers for any of the Products.
GENSIA shall ensure that any third-party manufacturer complies with OHMEDA PPD's
inspection and audit rights as set forth in this Agreement with respect to such
third party's manufacturing facilities and records that relate to the Products.
3.19 PROVISION OF DOCUMENTS TO CUSTOMERS. GENSIA will provide, at OHMEDA
PPD's request, specific documentation relating to the quality of manufacturing
operations and regulatory history for the Products as requested by OHMEDA PPD's
customers when such document request is considered reasonable by GENSIA or when
such documents would be available under the Freedom of Information Act.
4. REGULATORY SUBMISSIONS AID RECALLS
4.1 REGULATORY APPROVAL. GENSIA represents that for each of the Products
listed in Exhibit D it has an FDA approved ANDA or that such Products are
grandfathered pursuant to Xxxxxxx 000 xx xxx Xxxxxx Xxxxxx Food, Drug and
Cosmetic Act. GENSIA shall use commercially reasonable efforts to obtain an ANDA
approval for all remaining Products. GENSIA will hold product registrations in
the Territory for each of the Products and all Products supplied by GENSIA
hereunder shall be sold pursuant to such product registrations. During the
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term of this Agreement GENSIA shall maintain in full force and effect each
approved ANDA for a Product and comply with all conditions attached to each such
ANDA.
4.2 REGULATORY CONTACTS. GENSIA shall be responsible for all regulatory
contacts and filings with the FDA. GENSIA agrees to consult with OHMEDA PPD
prior to any material meetings or filings with the FDA with respect to any of
the Products after ANDA approval. OHMEDA PPD shall have the right to attend any
material meetings with the FDA with respect to the Products after ANDA approval.
GENSIA shall provide OHMEDA PPD in a timely fashion with copies of all material
correspondence with the FDA that relates to any of the Products after ANDA
approval.
4.3 CONSULTATIONS. GENSIA and OHMEDA PPD agree to consult from time to
time on the need for changes in prescribing information (package insert) or in
the labelling of packaging and containers of the Products or in the Product
information supplied to customers, the medical profession or patients. GENSIA
and OHMEDA PPD agree to negotiate in good faith to their mutual benefit with
respect to such changes.
4.4 ADVERSE EXPERIENCE REPORTING. OHMEDA PPD and GENSIA shall report to
the other any information that they have knowledge of concerning any adverse
drug experience in connection with the use of the Products, including the
incidence or severity thereof, associated with non-clinical toxicity studies,
clinical uses, studies, investigations or tests, whether or not determined to be
attributable to any of the Products. Reports of routine adverse drug experiences
of the type defined in Section 214.80 of Title 21 of the United
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States Code of Federal Regulations shall be exchanged by each party on a
quarterly basis. Reports of serious adverse drug experiences of the type defined
in Sections 312.32 and 314.80 of Title 21 of the United States Code of Federal
Regulations shall be made available to the other party within five (5) days
after a party becomes aware of such adverse drug experience. Upon receipt of any
such information concerning any serious adverse drug experience by either OHMEDA
PPD or GENSIA, the parties shall promptly consult each other and use their best
efforts to arrive at a mutually acceptable procedure for taking such possible
actions as appropriate or required under the circumstances; provided, however,
that nothing contained herein shall be construed as restricting the right or
duty of either party to make a required report or submission to the FDA or take
any other action that it deems to be appropriate or required by applicable law
or regulation. In any event, the responsibility of making any reports of adverse
drug experience or other required reports to the FDA shall be upon GENSIA as
holder of the product registration for each of the Products.
4.5 RECALL ACTION.
(a) In the event OHMEDA PPD should be required or should voluntarily
decide to initiate a recall, Product withdrawal, or field correction of any
Products in the Territory pursuant to this Agreement, OHMEDA PPD through its
designee, the OHMEDA PPD Vice President of Quality, shall notify GENSIA and
provide a copy of its proposal, including the recall letter, for review prior to
initiation of such action. In conjunction with such recall, GENSIA shall assist
in the investigation to determine the cause and extent of the problem.
(b) In the event that GENSIA independently believes that a recall,
Product withdrawal, or field correction for Products may be necessary or
appropriate, GENSIA shall notify OHMEDA PPD through OHMEDA PPD's designee, the
OHMEDA PPD Vice President
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of Quality, of GENSIA's belief, and the parties shall fully cooperate with each
other concerning the necessity and nature of such action.
(c) All coordination of any recall or field correction activities
involving Products shall be handled by OHMEDA PPD whether or not such action was
initially requested by GENSIA.
4.6 EXPENSES. In the event that any Product is recalled as a result of
(1) the supply by GENSIA of Product that does not conform to the warranty set
forth in Section 3.1, or (2) the negligent or intentionally wrongful act of
GENSIA or its representatives, then GENSIA shall bear all of the costs and
expenses of such recall including without limitation expenses related to
communications and meetings with all required regulatory agencies, expenses of
replacement stock, the cost of notifying customers and costs associated with
shipment of recalled Product from customers and shipment of an equal amount of
replacement Product to those same customers. In the event that any Product is
recalled as a result of the negligent or intentionally wrongful act of OHMEDA
PPD or its representatives, then OHMEDA PPD shall bear all of the costs and
expenses of such recall, including without limitation expenses related to
communications and meetings with all required regulatory agencies, expenses of
replacement stock, the cost of notifying customers and costs associated with
shipment of recalled Product from customers and shipment of an equal amount of
replacement Product to those same customers. To the extent that the reason for
any recall of Products hereunder is in part the responsibility of GENSIA and in
part the responsibility of OHMEDA PPD or is not due to the fault of either
party, then the expenses shall be allocated in an equitable manner between the
parties.
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4.7 RECALL RECORDS. GENSIA shall maintain complete and accurate recall
records for such periods as may be required by applicable law, but in no event
less than three (3) years, of all the Products sold by it.
5. CONSIDERATION.
5.1 TRANSFER PRICE. The price for each Product presentation ("Transfer
Price"), other than Hetastarch, to be delivered by GENSIA during the term of
this Agreement shall be the applicable Per Unit Materials Cost for each Product
presentation times * * * OHMEDA PPD shall pay to GENSIA, upon shipment to OHMEDA
PPD, the quantities of each Product presentation delivered to OHMEDA PPD
multiplied by the applicable Transfer Price for such Product presentation. The
terms of payment are net thirty (30) days from date of invoice.
5.2 ADJUSTMENTS TO TRANSFER PRICE. Except as otherwise noted, set forth
on Exhibit C is a calculation by GENSIA of the Per Unit Materials Cost for each
Product presentation based * * * together with the resulting Transfer Price for
each Product presentation based on such Per Unit Materials Cost. The Per Unit
Materials Costs portion of the Transfer Price of each Product presentation shall
be adjusted at the beginning of each Annual Period during the term of this
Agreement. GENSIA shall provide written notice of such adjustment thirty (30)
days prior to the date of the adjustment. Such adjustment will be based on the
then current actual invoice costs of Materials used to manufacture and package
Products to be delivered to OHMEDA PPD during the applicable period.
5.3 ROYALTY. In addition to the Transfer Price, for each Product
presentation detailed in Section 5.1 hereof, other than Hetastarch, OHMEDA PPD
will pay to GENSIA a royalty, "Royalty", * * * on Products delivered by GENSIA
and sold by OHMEDA PPD in the Territory.
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*** Confidential material redacted and separately filed with the Commission
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OHMEDA PPD will provide payment to GENSIA on a quarterly basis not more than
sixty (60) days following the end of each of the first three (3) quarters of an
Annual Period. Each payment shall be accompanied by a statement showing the Net
Sales for the applicable quarter and the calculation of the royalty fee in
accordance with this Section 5.3.
5.4 ANNUAL RECONCILIATION AND ADJUSTMENT. Within sixty (60) days after
the end of an Annual Period, OHMEDA PPD shall deliver to GENSIA a report setting
forth a determination of the Royalty for the applicable Annual Period calculated
in accordance with Section 5.3, using aggregate Net Sales and Transfer Prices
for the applicable Annual Period, including any year-end reconciliations. Such
Royalty for the Annual Period shall be reduced by the aggregate total of Royalty
payments made by OHMEDA PPD for each of the previous three (3) quarters during
the Annual Period. If the resulting amount is a positive number, then OHMEDA PPD
shall owe GENSIA that amount. If the resulting number is a negative number, then
GENSIA shall owe OHMEDA PPD that amount.
5.5 HETASTARCH.
(a) The purchase price payable to GENSIA for each unit of Hetastarch to
be delivered during the term of this Agreement shall be based on unit sales by
OHMEDA PPD during each Annual Period in accordance with the following schedule:
* * *
For purposes of this Section 5.5, "Average Selling Price" shall mean Net Sales
for the applicable period divided by the number of units sold, less returns,
during the applicable period.
----------
*** Confidential material redacted and separately filed with the Commission
-20-
(b) For invoicing purposes, the parties shall set an interim per unit
price of Hetastarch to be paid by OHMEDA PPD. The terms of payment are net
thirty (30) days from the date of invoice. The initial interim price per unit of
Hetastarch is set forth in Exhibit C. Such interim price per unit shall be
adjusted at the time of receipt of the next FDA ANDA deficiency letter related
to Hetastarch and thereafter shall be adjusted quarterly on the basis of * * *
The interim per unit price paid by OHMEDA PPD shall be subject to
reconciliations with the actual per unit purchase price in accordance with
Section 5.5(c).
(c) Within sixty (60) days after the end of each quarter during an Annual
Period, OHMEDA PPD shall deliver to GENSIA a report setting forth a calculation
of the amount of the purchase price payable to GENSIA for Hetastarch for the
Annual Period through the end of the applicable quarter. * * * The amount of the
purchase price for the Annual Period through the end of the applicable quarter
as determined in this Section 5.5 shall be reduced by the interim purchase price
paid by OHMEDA PPD for each unit sold during the Annual Period through the end
of the applicable quarter on a FIFO basis, and then further appropriately
reduced or increased as a result of any prior quarterly adjustments within the
Annual Period. If the resulting number is positive, then such amount shall be
payable to GENSIA. If the resulting number is negative, then such amount shall
be payable to OHMEDA. Any monies due shall be payable within ten (10) days of
the delivery of the report. An example of Hetastarch compensation payments for
an Annual Period is set forth in Schedule 5.5.
OHMEDA PPD may return damaged or shortdated units of Hetastarch for credit
(determined as set forth below) provided that, in the case of shortdated units,
OHMEDA has used commercially responsible efforts to sell such units. In the
event that any units purchased by OHMEDA PPD ultimately cannot be sold by OHMEDA
PPD, then the credit per unit to
----------
*** Confidential material redacted and separately filed with the Commission
-21-
OHMEDA shall be equal to the interim price per unit (as defined in Section 5.5
(b) above) reduced by the actual GENSIA cost to manufacture. For purposes of
this Section 5.5, "shortdated" shall mean having less than six (6) months shelf
life remaining.
(d) In the event that the Average Selling Price for units of Hetastarch
drops below * * * during any quarterly reporting period hereunder, then the
parties shall renegotiate the purchase price payable to GENSIA for units of
Hetastarch on a * * * consistent with the other Products set forth on Exhibit C.
5.6 TAXES. All federal, state, district, local or other governmental
authority income or similar tax measured by income that is imposed on either
party as a result of income, shall be the responsibility of such party. Any
federal, state, district, local or other governmental authority sales or use
tax, excise or similar tax assessed on the sale of Products by OHMEDA PPD shall
be paid by OHMEDA PPD.
5.7 INSPECTION. During the term of this Agreement and for a period of one
(1) year thereafter, each party shall have the right, at its own expense, to
have a public accounting firm to which the other party has no reasonable
objection examine the relevant books and records of account of such party during
business hours not more often than once each calendar year to determine whether
appropriate accounting and payment have been made pursuant to this Section 5.
Such inspection rights shall be limited to the records relating to the three
most recently concluded Annual Periods at the time of each inspection provided
that no such Annual Period shall be subject to inspection more than once. The
accounting firm shall disclose to the requesting party only whether the records
are correct or not and the specific details concerning any discrepancies. No
other information shall be shared. Each party shall preserve all relevant
----------
*** Confidential material redacted and separately filed with the Commission
-22-
records for a period of seven (7) years from the date of the applicable record.
If a party proposes to destroy any relevant records that have been held for
seven (7) years, then such party shall first advise the other party in writing,
and if the other party objects to such destruction, it shall store for or
deliver such relevant records to the other party, at the other party's expense.
5.8 CUSTOMER PRICING. OHMEDA PPD shall have sole discretion in setting
customer pricing for the Products in the Territory. Nevertheless, it is not the
intention of OHMEDA PPD to offer to sell the Products as loss leaders in
connection with the promotion of other OHMEDA PPD products.
6. TERM AND TERMINATION.
6.1 TERM AND RENEWAL. The obligation of the parties hereunder shall
effectively commence on January 1, 1996 and continue for five (5) Annual Periods
provided the Agreement will automatically be extended for additional and
successive terms of one (1) year each unless either party terminates this
Agreement effective the end of the initial term or any renewal term upon two (2)
years prior written notice.
6.2 TERMINATION FOR BREACH. This Agreement may be terminated by either
party if the other party fails to remedy and make good any material default in
the performance of any condition or obligation under this Agreement within sixty
(60) days of the date a written notice of such default and intention to
terminate is sent to the defaulting party.
6.3 TERMINATION FOR BANKRUPTCY. This Agreement may be terminated by
either party, forthwith, or at any time thereafter by notice to the other if the
other files a petition of
-23-
bankruptcy, is adjudged bankrupt, takes advantage of any insolvency act or
executes a xxxx of sale, deed of trust or assignment for the benefit of
creditors.
6.4 TERMINATION FOR FORCE MAJEURE. This Agreement may be terminated by a
party, upon thirty (30) days written prior notice in the event of the other
party's inability to substantially perform its obligations hereunder for more
than ninety (90) days due to an event of force majeure.
6.5 NO WAIVER. The failure of either party to terminate this Agreement
by reason of the breach of any of its provisions by the other party shall not be
construed as a waiver of the rights or remedies available for any subsequent
breach of the terms and provisions of this Agreement.
6.6 ACCRUED LIABILITIES. Termination of this Agreement for any reason
shall not discharge either party's liability for obligations incurred hereunder
at the time of such termination and shall be without prejudice to the rights and
remedies of either party with respect to any antecedent breach of any of the
provisions of this Agreement. GENSIA shall deliver and OHMEDA PPD shall pay
GENSIA for any finished Products that were ordered by OHMEDA PPD prior to
termination. Upon termination of this Agreement, OHMEDA PPD shall have the right
to sell any of its remaining inventory of Products in the Territory on the same
terms as set forth in this Agreement.
6.7 PROPERTY. In the event of termination of this Agreement for whatever
cause, in addition to the other obligations of the parties hereunder, each party
shall return to the other party or to the other party's designee no later than
thirty (30) days after the effective date of termination all of such other
party's property, including, but not limited to, all proprietary
-24-
information, in its possession, except to the extent required to be retained by
law or to comply with such party's continuing obligations hereunder.
7. INDEPENDENT CONTRACTORS.
The parties acknowledge, agree and declare that the relationship hereby
established between them is solely that of provider and recipient of
manufacturing services and that each party hereto is an independent contractor
with respect to the other.
8. INDEMNIFICATION.
8.1 INDEMNIFICATION BY GENSIA. GENSIA agrees to indemnify, defend and
hold harmless OHMEDA PPD, its affiliates and their respective employees against
any and all third-party claims, losses, damages and liabilities, including
reasonable attorney's fees, incurred by any of them arising out of any breach of
any obligation by GENSIA hereunder, any misrepresentation by GENSIA hereunder,
any negligent or intentionally wrongful act or omission by GENSIA in connection
with the manufacture of Products hereunder, or any inadequacy or failure to warn
in the prescribing information for the Products unless such prescribing
information has been modified by the mutual consent of the parties after ANDA
approval.
8.2 INDEMNIFICATION BY OHMEDA PPD. OHMEDA PPD agrees to indemnify,
defend and hold harmless GENSIA, its affiliates and their employees against any
and all third-party claims, losses, damages and liabilities, including
reasonable attorney's fees, incurred by any of them arising out of any breach of
any obligation by OHMEDA PPD hereunder or any misrepresentation by OHMEDA PPD
hereunder or any negligent or intentionally wrongful act or
-25-
omission of OHMEDA PPD in connection with the distribution or sale of the
Products in the Territory.
8.3 PATENT INDEMNITY. GENSIA shall, at its expense, defend or settle any
actions brought against OHMEDA PPD, its Affiliates, its employees, or any of
their customers alleging that any of the Products, or the use of any of them in
accordance with any approved indications, infringes one or more claims of a
patent. GENSIA shall pay all damages and costs awarded by a court of competent
jurisdiction, unappealed and unappealable.
8.4 PROCEDURE. If OHMEDA PPD, its affiliates or their respective
employees or customers, or GENSIA, its affiliates or their respective employees
(in each case an "Indemnified Party") receive any written claim which such
Indemnified Party believes is the subject of indemnity hereunder by GENSIA or
OHMEDA PPD as the case may be (in each case an "Indemnifying Party"), the
Indemnified Party shall, as soon as reasonably practicable after forming such
belief, give notice thereof to the Indemnifying Party; provided, that the
failure to give timely notice to the indemnifying Party as contemplated hereby
shall not release the Indemnifying Party from any liability to the Indemnified
Party unless the Indemnifying Party demonstrates that the defense of such claim
is prejudiced by such failure. The Indemnifying Party shall have the right, by
prompt notice to the Indemnified Party, to assume the defense of such claim, at
its cost, with counsel reasonably satisfactory to the Indemnified Party. If the
Indemnifying Party does not so assume the defense of such claim or, having done
so, does not diligently pursue such defense, the Indemnified Party may assume
such defense, with counsel of its choice, but at the cost of the Indemnifying
Party. If the Indemnifying Party so assumes such defense, it shall have absolute
control of the conduct of the litigation; the Indemnified Party may,
nevertheless, participate therein through counsel of its choice and at its cost.
The party not
-26-
assuming the defense of any such claim shall render all reasonable assistance to
the party assuming such defense, and all out-of-pocket costs of such assistance
shall be for the account of the Indemnifying Party. No such claim shall be
settled other than by the party defending the same, and then only with the
consent of the other party, which shall not be unreasonably withheld; provided,
that the Indemnified Party shall have no obligation to consent to any settlement
of any such claim which imposes on the Indemnified Party any liability or
obligation which cannot be assumed and performed in full by the Indemnifying
Party.
8.5 MODIFICATIONS TO PRESCRIBING INFORMATION. The parties shall be
mutually responsible with respect to any modifications to prescribing
information for a Product that are agreed to by the parties after ANDA approval
of such Product. To the extent that a third party claim arises out of such
modifications to prescribing information, then any resulting liabilities,
losses, costs, damages, or expenses shall be equitably allocated between the
parties.
9. INSURANCE.
Each party shall carry comprehensive general liability insurance,
including product liability insurance against claims for bodily injury or
property damage in an amount of not less than $3,000,000 per occurrence and
$8,000,000 in the aggregate. Such policy shall be endorsed to include the
following: (a) the policies shall provide for thirty (30) days' notice to the
other party of cancellation or material change in the coverage before such
cancellation or change takes effect; and (b) contractual liability including
this Agreement. Each party shall carry the insurance coverage set forth herein
during the term of this Agreement and for five (5) years following termination
of this Agreement. Such insurance shall be with insurance companies
-27-
licensed to do business in California and the insurers shall have a Best's
Insurance rating of A:X or better.
10. REMEDIES AID LIMITATION OF LIABILITY.
10.1 REMEDIES. In the event that GENSIA fails to supply Products in
accordance with the terms of this Agreement, then, unless an event of force
majeure has occurred, GENSIA shall reimburse OHMEDA PPD any increased cost of
obtaining Products from an alternative source, provided that OHMEDA PPD uses
reasonable commercial efforts to obtain such Products from an alternative
generic source. In addition, GENSIA agrees to reimburse OHMEDA PPD for any
losses, liabilities, or expenses that are incurred as a result of the inability
of OHMEDA PPD to comply with its supply obligations in customer agreements when
such inability to supply by OHMEDA PPD arises as a result of GENSIA's failure to
supply Products in accordance with the terms of this Agreement. A copy of an
illustrative OHMEDA PPD supply guarantee clause with a customer is set forth in
Exhibit F.
10.2 LIMITATION. EXCEPT AS SET FORTH IN SECTION 10.1, NEITHER PARTY SHALL
BE LIABLE TO THE OTHER FOR SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES UNDER
ANY CIRCUMSTANCES OR UNDER ANY THEORY OF LAW.
11. FORCE MAJEURE AND EXCESSIVE DEMAND.
11.1 FORCE MAJEURE. Neither party shall be liable to the other for
default or delay in the performance of its obligations under this Agreement, if
such default or delay shall be caused directly or indirectly by accident, fire,
flood, riot, war, act of God, embargo, strike, failure or
-28-
delay of normal source of supply of materials, or delay of carriers, or
governmental orders or regulations, provided same are not due to the fault or
neglect of such party and provided further that any such delay or failure shall
be remedied by such party as soon as possible after the removal of the cause of
such failure or delay.
11.2 EXCESSIVE DEMAND. In the event of a shortage or anticipated shortage
of the Products and/or delay in shipment or delivery occasioned by any of the
force majeure events set forth in Section 11.1 herein, GENSIA will endeavor to
allocate equitably the available product to OHMEDA PPD and to GENSIA's own use
on the basis of historic useage over the previous twelve month period. If the
demand by OHMEDA PPD during an Annual Period exceeds the amount forecasted in
the initial Demand Schedule for such Annual Period provided by OHMEDA PPD,
GENSIA will provide priority to OHMEDA PPD products up to 125% of the forecasted
quantity set forth in such Demand Schedule. GENSIA will use commercially
reasonable efforts to allocate equitably any demand by OHMEDA PPD in excess of
125% of such forecasted annual quantity.
12. CONFIDENTIALITY.
Any information or data (including but not limited to, any technical
information, experience or data) regarding either party's formulations, plans,
programs, plants, processes, technical materials, products, production
requirements, standard specifications, costs, equipment, operations, procedures,
instructions or customers (all of which is herein referred to as "Confidential
Information") is the sole property of the respective party. Each party shall
treat the other party's confidential information in the same protective manner
that it treats its own confidential information. Parties shall not use, except
for the purpose of carrying out this
-29-
Agreement, or disclose to others or permit their employees or agents to use,
except for the purpose of carrying out this Agreement, or disclose to others,
during the term of this Agreement and for a period of five (5) years from the
date of termination or expiration of this Agreement Confidential Information
which has heretofore come or hereafter may come within the knowledge of, or
which has been or may hereafter be acquired or developed by the respective
party, its employees or agents, in the performance of any services hereunder.
This paragraph shall not prevent either party from using or disclosing to others
information:
(i) which is known to the receiving party at the time it is
disclosed by or obtained from the disclosing party, which knowledge can be
established by competent evidence; or
(ii) which is, or through no fault of the receiving party becomes,
lawfully available to the public; or
(iii) which lawfully becomes available to the receiving party from a
source other than the disclosing party. Upon termination of this
Agreement, if requested, the receiving party shall deliver to the
disclosing party all notes, drawings, blueprints, manuals, letters,
notebooks, reports of or pertaining to Confidential Information, including
all copies thereof, and all other Confidential Information which is in the
possession of or under the control of the receiving party.
Parties shall restrict access to Confidential Information to as few as
practicable of their employees, and in all cases shall restrict such knowledge
to only those employees who are directly connected with the performance of the
services hereunder.
-30-
13. COMPLIANCE WITH LAW.
Each party shall comply with, and shall not be in violation of, any valid
applicable national, state or local statutes, laws, ordinances, rules,
regulations, or other governmental orders in the Territory.
14. ADDITIONAL PRODUCTS.
During the twelve (12) month period after the execution of this Agreement,
OHMEDA PPD shall have the option to add any of the products listed in Exhibit E
to this Agreement by providing written notice to GENSIA. Immediately after
receipt by GENSIA of such notice of the exercise of OHMEDA PPD's right to
include an additional product pursuant to this Section 14, then such product
shall be incorporated into the definition of "Products" hereunder and GENSIA
shall use commercially reasonable efforts to obtain ANDA approval of such
product in accordance with Section 4.1 and thereafter shall supply such product
on commercial terms to be negotiated by both parties.
15. CAPITATION AGREEMENTS.
To the extent that OHMEDA PPD offers capitation arrangements to customers
that include the supply of Products and such capitation arrangements are not on
a product basis, then the parties shall act in good faith to agree on a
methodology to equitably calculate net sales of such Products covered by such
capitation arrangements on a different basis than set forth in Section 1.8.
-31-
16. NOTICES.
Any notice or request expressly provided for or permitted under this
Agreement shall be in writing, delivered manually or by mail, telegram, telefax
or cable and shall be deemed sufficiently given if and when received by the
party to be notified at its address first set forth below, or if and when mailed
by registered mail or certified mail, postage prepaid, addressed to such party
at such address. Either party, by notice to the other, may change its address
for receiving such notices.
To GENSIA : GENSIA LABORATORIES, LTD.
00 Xxxxxx
Xxxxxx, Xxxxxxxxxx 00000-0000
Attention: President and Chief Operating
Officer
with copy to: GENSIA INC.
0000 Xxxxx Xxxxxx Xxxxx
Xxx Xxxxx, Xxxxxxxxxx 00000-0000
Attention: General Counsel
TO OHMEDA PPD: OHMEDA PPD
c/o Ohmeda Pharmaceutical Products Division Inc.
000 Xxxxx Xxxx
XX Xxx 000
Xxxxxxx Xxxxxx, Xxx Xxxxxx 00000
Attention: President
with a copy to: THE BOC GROUP, INC.
000 Xxxxxxxx Xxxxxx
Xxxxxx Xxxx, Xxx Xxxxxx 00000
Attention: Law Department
17. GOVERNING LAW/DISPUTE RESOLUTION.
(a) APPLICABLE LAW. The rights and obligations of the parties to this
Agreement and this Agreement shall be governed by, construed and enforced in
accordance with the laws of the State of
New York without regard to the
provisions thereof concerning conflict of laws.
-32-
(b) GOOD FAITH. Any controversy, claim or dispute arising out of or
relating to this Agreement or the breach thereof shall be settled, if possible,
through good faith negotiation between the parties. Such good faith negotiation
shall commence promptly upon a party's receipt of notice of any claim or dispute
from the other party and continue for a period of sixty (60) days.
(c) ARBITRATION. If such efforts are not successful such controversy,
claim or dispute shall be resolved by arbitration. Such arbitration shall take
place in
New York,
New York and be conducted in the English language and it
shall proceed in accordance with the Commercial Arbitration Rules of the
American Arbitration Association ("AAA") and in accordance with the laws of the
State of
New York without regard to the provisions thereof concerning conflict
of laws. At the end of the sixty (60) day period of good faith negotiations
between the parties, unless the parties mutually agree to extend this time
period, OHMEDA PPD and GENSIA shall each select one arbitrator within thirty
(30) days. The third arbitrator shall be selected by the arbitrators chosen by
OHMEDA PPD and GENSIA respectively. If the party selected arbitrators fail to
agree upon selection of a third arbitrator within thirty (30) days, the AAA will
make an administrative appointment. The arbitration award shall be final and
binding regardless of whether one of the parties fails or refuses to participate
in the arbitration and it shall be enforceable by any court of competent
jurisdiction. Costs of arbitration are to be split by the parties in the
following manner: OHMEDA PPD shall pay for the arbitrator it chooses, GENSIA
shall pay for the arbitrator it chooses, and the cost of the third arbitrator
shall be split equally. All other arbitration costs shall also be split equally.
The parties agree that service of any notice in the course of the proceedings
pursuant to this Section 17 made at the respective addresses as provided in
Section 16 shall be valid and sufficient.
-33-
18. COMPLETE CONTRACT.
This document, together with the exhibits thereto constitutes the complete
and exclusive statement of the terms of this Agreement between the parties
hereto with reference to the subject matter hereof, and no statement or
agreements, oral or written, made prior to or at the signing hereof shall vary
or modify the written terms hereof, and neither party shall claim any
modification or rescission from any provision hereof unless such modification or
rescission is in writing, signed by the other party.
19. NONASSIGNABILITY.
During the term of this Agreement the rights of either party under this
agreement shall not be assigned, nor shall the performance of either party's
duties be delegated without the other party's prior written consent provided
that either party may assign this Agreement to an Affiliate or to a purchaser of
all or of substantially all of the party's business.
20. WAIVER.
The waiver by any party of any breach by another party of any term or
condition of this Agreement shall not constitute a waiver of any subsequent
breach or nullify the effectiveness of that term or condition.
-34-
21. SURVIVAL.
The obligations of the parties contained in Sections 3.1, 3.2, 3.3, 3.9,
3.11, 3.14, 3.16, 3.17, 3.18, 3.19, 4.4, 4.5, 4.6, 4.7, 5.6, 5.7, 6.6, 6.7, 8,
10, 12, 13, 16, 17, 18, and 20 shall survive the termination of this Agreement.
IN WITNESS WHEREOF, the parties have caused this agreement to be executed
by their respective duly authorized representatives as of the day and year first
above written.
GENSIA LABORATORIES, LTD.
By /s/ Xxxx X. Xxxxxxx
--------------------------------------
Name: Xxxx X. Xxxxxxx
----------------------------
Title: Vice President, Corp. Dev.
----------------------------
OHMEDA PHARMACEUTICAL PRODUCTS DIVISION INC.
By /s/ Xxxxxx X. Xxxxxx
--------------------------------------
Name: Xxxxxx X. Xxxxxx
----------------------------
Title: Vice President, Finance
----------------------------
-35-
SCHEDULE 5.5
* * *
----------
*** Confidential material redacted and separately filed with the Commission
-36-
EXHIBIT A
=======================================================================
PRODUCT FILL/VIAL SIZE CAT#
-----------------------------------------------------------------------
NEOSTIGMINE 1MG/ML l0ML 2704-03
-----------------------------------------------------------------------
NEOSTIGMINE 0.5MG/ML 1ML/2ML 2711-03
-----------------------------------------------------------------------
NEOSTIGMINE 0.5MG/ML 10ML 2714-03
-----------------------------------------------------------------------
PANCURONIUM 1MG/ML l0ML 2804-03
-----------------------------------------------------------------------
PANCURONIUM 2MG/ML 2ML 2812-04
-----------------------------------------------------------------------
PANCURONIUM 2MG/ML 5ML 2823-04
-----------------------------------------------------------------------
PHENYLEPHRINE 2ML 1631-04
=======================================================================
=======================================================================
THIOPENTAL 1 GM KIT 2530-01
-----------------------------------------------------------------------
THIOPENTAL 2.5GM KIT 2540-01
-----------------------------------------------------------------------
THIOPENTAL 5GM KIT 2550-01
-----------------------------------------------------------------------
THIOPENTAL 500MG SYR KIT 2580-01
-----------------------------------------------------------------------
BUMETANIDE .25MG/ML 2ML 5062-03
-----------------------------------------------------------------------
BUMETANIDE .25MG/ML 4ML/5ML 5063-03
-----------------------------------------------------------------------
BUMETANIDE .25MG/ML 10ML 5064-03
=======================================================================
=======================================================================
METOCLOPRAMIDE 2ML 4502-04
-----------------------------------------------------------------------
SOD CHLOR 23.4% 30ML 5336-04
-----------------------------------------------------------------------
SOD CHLOR 23.4% 100ML 5338-03
-----------------------------------------------------------------------
SODIUM NITROPRUSSIDE 2ML 1802-01
-----------------------------------------------------------------------
ATROPINE 0.4MG/ML 1ML/2ML 2501-04
-----------------------------------------------------------------------
ATROPINE l.0MG/ML 1ML/2ML 2511-04
-----------------------------------------------------------------------
ATROPINE 0.4MG/ML 20ML 2525-03
=======================================================================
=======================================================================
DOBUTAMINE 20ML 1815-03
=======================================================================
=======================================================================
HETASTARCH 6% in 0.9% 500ML, 12 pack 5079-0701
-----------------------------------------------------------------------
NaCl 500ML, 4 pack 5079-0901
=======================================================================
-37-
EXHIBIT B
FINISHED PRODUCT SPECIFICATIONS AND DATA SHEET
(ATTACHED)
Page 6
EXHIBIT C
***
***Confidential material redacted and separately filed with the Commission.
EXHIBIT D
GENSIA APPROVED ANDA'S AND "GRANDFATHERED" PRODUCTS
==============================================================================
AADA/ANDA NUMBER PRODUCT
------------------------------------------------------------------------------
---- GF Atropine Sulfate Injection, USP
------------------------------------------------------------------------------
ANDA 74-206 Dobutamine Hydrochloride Injection
------------------------------------------------------------------------------
ANDA 00-000 Xxxxxxxxxxxxxx injection, USP
------------------------------------------------------------------------------
---- GF Neostigmine Methylsulfate Injection, USP
------------------------------------------------------------------------------
ANDA 72-759 Pancuronium Bromide Injection
------------------------------------------------------------------------------
ANDA 72-760 Pancuronium Bromide Injection
------------------------------------------------------------------------------
---- GF Phenylephrine Hydrochloride Injection, USP 1%
------------------------------------------------------------------------------
---- GF Sodium Chloride Injection, USP 23.4%
------------------------------------------------------------------------------
ANDA 73-465 Sodium Nitroprusside Injection
------------------------------------------------------------------------------
---- GF Thiopental Sodium for Injection
==============================================================================
GF = "Grandfathered"
Page 8
EXHIBIT E
Vecuronium
----------
10 mg vial
10 mg vial w/diluent
20 mg vial
20 mg vial w/diluent
Propofol
--------
10 mg/ml, 20 xx xxxx
10 mg/m1, 50 xx xxxx
10 mg/ml, 100 xx xxxx
10 mg/ml pre-filled syringes
Page 9
EXHIBIT F
SAMPLE SUPPLY GUARANTEE CLAUSE
"In the event of the failure of Vendor
(OHMEDA-PPD) to perform in accordance
with the terms of this Agreement,
(Buying Group Member) may purchase the
Products from other sources and the
Vendor shall be liable and responsible
to [Buying Group Member] for all
reasonable costs in excess of the Award
Price."
The clause set forth above is illustrative of supply guarantee obligations
of OHMEDA PPD in customer agreements. It is understood and agreed that
incorporation of this clause as an example is not to be deemed definitive of
such obligations and furthermore is not intended to foreclose such remedies as
may be available to OHMEDA's customers under the applicable provisions of the
Uniform Commercial Code in the event of a failure to supply.
Page 10
ADDENDUM TO MANUFACTURING AND
DISTRIBUTION AGREEMENT
Pursuant to Section 14 of the Manufacturing and Distribution Agreement
dated as of February 27, 1996 (the "Agreement"), the parties hereto agree that
propofol shall be added to the Agreement under the terms and conditions set
forth in this addendum (the "Addendum"). Except as specifically set forth
herein, or except to the extent they are inconsistent with the terms and
conditions of this Addendum, the terms and conditions of the Agreement shall
apply to the manufacture and distribution of propofol pursuant hereto. Except as
otherwise set forth herein, capitalized terms shall have the meanings ascribed
to them in the Agreement.
1. PRODUCT. For purposes of this Addendum, the term "Product" shall
mean the following products, manufactured and packaged by Gensia or its
permitted contract manufacturer in finished format with the OHMEDA PPD label:
(a) Propofol filled in 20mL, 50mL and 100mL vials (10mg/mL)
(b) Propofol filled in 20mL syringes (10mg/mL)
2. TERM. This Addendum shall become effective on the date set forth
below, and shall remain in effect for a period of two (2) years from the date of
approval of GENSIA's ANDA for the Product described in Section 1(a), above
("Vial Product").
3. LABELING. The Product shall be finished in OHMEDA PPD trade dress
provided by OHMEDA PPD, in accordance with the provisions of Section 3.7 of the
Agreement.
4. FEE. OHMEDA PPD shall pay GENSIA the sum of *** on October 1, 1996.
5. PRICE. The price for each presentation of the Product is set forth
in Schedule A attached hereto. In the event both Xxxxxx Laboratories and OHMEDA
PPD are actively selling propofol (other than GENSIA manufactured propofol) in
the Territory on the first anniversary date of the approval of GENSIA's ANDA for
the Product, ***. GENSIA and OHMEDA PPD will cooperate in identifying methods to
reduce the cost of Product described in Section 1(b), above ("Syringe Product"),
***. GENSIA and OHMEDA PPD will also work to reduce the cost of Vial Product,
and cost savings that relate directly to such cost reduction efforts will be
passed on to OHMEDA PPD in the form of unit price reductions on future units
purchased as such savings are realized. GENSIA shall not be paid any royalty
pursuant to Section 5.3 of the Agreement with respect to the Product
presentations purchased by OHMEDA PPD pursuant to this Addendum.
6. REQUIRED PURCHASES. OHMEDA PPD shall *** of Product from GENSIA in
the first twelve (12) month period commencing on the approval of GENSIA's ANDA
for the Product and (ii) *** units of Product from GENSIA in the next twelve
(12) month period during
--------
*** Confidential material redacted and separately filed with the Commission.
-1-
the term of this Addendum. Such minimum unit purchase obligation may be
fulfilled by the purchase of any mix of available presentations of the Product.
In the event OHMEDA PPD fails to purchase such minimum quantity of units during
either of the foregoing twelve (12) month periods, OHMEDA PPD shall pay to
GEENSIA, within thirty (30) days after the close of such twelve (12) month
period, a cash payment equal to the difference between (a) the amounts which
would have been due GENSIA from OHMEDA PPD pursuant hereto had OHMEDA PPD
purchased such minimum quantity of Product from GENSIA and (b) the actual
xxxxxxxx to OHMEDA PPD by GENSIA for such twelve (12) month period for Product.
For purposes of this Section 6, the payments referred to in clause (a) above
shall be calculated by assuming that OHMEDA PPD would have purchased the same
mix of presentations of the Product as the then current IMS mix of propofol
dosing sizes as reported for the twelve (12) months ending at the end of the
quarter preceding the close of the contract year in question. OHMEDA PPD may
purchase a *** of Product from GENSIA in each twelve (12) month period during
the term of this Addendum. GENSIA's obligation under Section 11.2 of the
Agreement to provide priority to OHMEDA PPD products shall apply to only 100% of
the forecasted quantity of Product. Notwithstanding anything in the foregoing to
the contrary, purchases by OHMEDA PPD of units of *** of the total units of
Product purchased hereunder.
7. PAYMENT TERMS. Payment terms for Product purchased hereunder shall
be net thirty (30) days from the date of shipment.
8. FORECASTS AND ORDERS. GENSIA shall keep OHMEDA PPD apprised of the
status of OHMEDA PPD's ANDA filing with respect to the Product and shall
immediately notify OHMEDA PPD in writing of approval by the FDA. OHMEDA PPD will
provide GENSIA with an initial forecast for the Product in writing upon receipt
from GENSIA of a copy of the conclusory paragraph of the ANDA deficiency letter
(or such other paragraph or portions of such paragraph as characterizes the
deficiency as major or minor) from FDA with respect to the Products. In the
event of a minor deficiency, such initial forecast shall be provided within five
(5) business days of OHMEDA PPD's receipt of such portions of the deficiency
letter; in the event of a major deficiency, such initial forecast shall be
provided within ninety (90) days of OHMEDA PPD's receipt of such portions of the
deficiency letter. GENSIA shall use its best efforts to deliver Product ordered
for the first two (2) months following FDA approval of the Product on the
delivery date required by OHMEDA PPD, and shall thereafter deliver products
within sixty (60) days from orders submitted in accordance with the procedures
set forth in Section 2.4 of the Agreement.
--------
*** Confidential material redacted and separately filed with the Commission.
-2-
IN WITNESS WHEREOF, the parties hereto have executed this Addendum as of
the 18th day of September, 1996.
GENSIA LABORATORIES, LTD.
By: /s/ Xxxxxxx X. Xxxxx
-------------------------------
Name: Xxxxxxx X. Xxxxx
Title: President and Chief
Operating Officer
OHMEDA PHARMACEUTICAL PRODUCTS DIVISION INC.
By: /s/ X. Xxxxxx
-------------------------------
Name: X. Xxxxxx
Title:
-3-
OHMEDA AND GENSIA PRICING SCHEDULE
***
----------
*** Confidential material redacted and separately filed with the Commission.
CONFIDENTIAL
AMENDMENT TO MANUFACTURING & DISTRIBUTION AGREEMENT
THIS SECOND AMENDMENT (the "Amendment), dated as of October 7, 1998,
amends that certain Manufacturing & Distribution Agreement by and between GENSIA
SICOR PHARMACEUTICALS, INC., a Delaware Corporation ("Gensia Sicor") (formerly
Gensia Laboratories, Ltd.) and XXXXXX PHARMACEUTICAL PRODUCTS INC., a Delaware
Corporation ("Xxxxxx PPI") (formerly Ohmeda Pharmaceutical Products Division
Inc) dated as of February 27, 1996, as amended (the "Agreement").
1. Section 1.0 of the Agreement shall be amended to add the following
definitions:
1.13 "Contracted Customer" shall mean persons with respect to which Gensia
Sicor has a direct customer contract for the Products in force for an existing
term as of the date of this Amendment, or a bid outstanding for the Products for
an existing term as of the date of this Amendment; provided such contracts may
not be materially amended and such contracts may not be extended by Gensia Sicor
and customers shall not be considered Contracted Customers after expiration of
said Gensia Sicor contracts, or during the term of any period of contract
extension by Baxter PPI, or during the term of any new contract by Baxter PPI;
and provided further that by definition, without limiting the generality of the
foregoing, Contracted Customers shall include hospitals, alternate care sites,
wholesalers/distributors, and group purchasing organizations and shall
specifically exclude persons for whom Gensia Sicor contract manufactures the
Products and any other persons who contract or market Products manufactured by
Gensia Sicor on Gensia Sicor's behalf.
1.14 "Transition Period" shall mean the time period between the date of
this Amendment and December 31, 1999.
1.15 "Variable Standard Costs" shall mean, for the purposes of this
Agreement, Gensia Sicor's actual variable standard costs for each Product
presentation determined in accordance with generally accepted accounting
principles and shall be calculated consistently with variable cost methodology
as used for financial accounting purposes throughout the Gensia Sicor
organization for its own products.
1.16 "Full Standard Costs" shall mean, for the purposes of this Agreement,
Gensia Sicor's actual full standard costs for each Product presentation
determined in accordance with generally accepted accounting principles and shall
be calculated consistently with full standard cost methodology as used for
financial accounting purposes throughout the Gensia Sicor organization for its
own products.
2. The Agreement shall be amended to add the following provisions after
Section 2.6 hereof:
2.7 EXCLUSIVITY. Subject to Section 2.8 hereof, during the term of this
Agreement and as of the date of this Amendment, Gensia Sicor grants to Baxter
PPI the exclusive right (exclusive even as to Gensia Sicor) to market and sell
the Products in the Territory. After the Transition Period set forth in Section
2.8 hereof, the Products shall be marketed and sold solely in Baxter trade dress
or in other such trade dress as approved by Baxter PPI. Notwithstanding
Page 1
the foregoing nothing herein shall require Gensia Sicor to breach its existing
agreement with American Pharmaceutical Partners ("APP").
2.8 TRANSITION PERIOD. Except as set forth below, the Products may be
marketed and sold in Gensia Sicor trade dress only to Contracted Customers until
the earlier of the expiration of such contracts or December 31, 1999. As of the
date of this Amendment, Gensia Sicor shall assign its contracts with Contracted
Customers to Baxter PPI and, subject to the terms set forth therein, Baxter PPI
shall supply such Contracted Customers with Product in Baxter PPI trade dress
after Product containing Gensia Sicor trade dress is exhausted. As soon as
reasonably practical Gensia Sicor shall take all commercially reasonable steps
to obtain consents to assign such contracts where consent is required. Following
the date of this Amendment and having successfully obtained consents to
assignment of Gensia Sicor contracts, Gensia Sicor shall not produce any
additional Product, except for atracurium, in Gensia Sicor trade dress.
Atracurium may be produced in Gensia Sicor trade dress until Baxter PPI takes
its first delivery of bulk atracurium besylate from Gensia Sicor.
Notwithstanding the foregoing, Products shall continue to be sold to Contracted
Customers in Gensia Sicor trade dress after the Transition Period, and Gensia
Sicor may continue to manufacture such Products in Gensia Sicor trade dress
after the Transition Period, if and only to the extent failure to do so would
cause Gensia Sicor to be in breach of any agreement with a Contracted Customer
or give Gensia Sicor reasonable grounds to believe that such Contracted Customer
would terminate such agreement, and provided that Gensia Sicor has used
reasonable commercial efforts to cause such Contracted Customer to consent to
substitution of Baxter PPI-labeled Product for Gensia Sicor-labeled Product.
Gensia Sicor shall attach to this Amendment a list of Contracted Customers,
Products covered and contract term. Royalty payments for Transition Period sales
shall be described in Section 5.3.
2.9 LICENSE. Subject to the provisions of this Section 2.9, Gensia Sicor
grants to Baxter PPI an exclusive license for the term of this Agreement to
make, have made, use and sell the Products (including the technology described
in Gensia Sicor's Product ANDAs and grandfathered Products documentation or any
changes or supplements thereto in the Territory); provided that Baxter PPI shall
not be permitted to sublicense such right other than to its Affiliates. In
consideration of the grant of such license, Baxter PPI agrees to (a) pay a
Royalty described in Section 5.3 hereof, and (b) purchase *** of both Baxter PPI
and Gensia Sicor combined (current) generic Product requirements for bulk
atracurium besylate from Gensia Sicor or its Affiliates at a price of *** upon
approval of a Baxter PPI ANDA supplement for the Gensia Sicor bulk drug
substance. Baxter PPI agrees to make commercially reasonable efforts to file its
supplemental ANDA for Gensia Sicor bulk atracurium besylate by October 31, 1998
and further to use commercially reasonable efforts to pursue the ANDA supplement
through to approval.
2.10 DILTIAZEM SUPPLY. Baxter PPI agrees to purchase Gensia Sicor's
finished dosage diltiazem sufficient to meet *** of Baxter PPI's *** for such
product after Baxter PPI has fulfilled its minimum purchase obligations under
its contracts with other suppliers for such product existing as of the date of
this Amendment.
2.11 VECURONIUM SUPPLY. Baxter PPI agrees to purchase Gensia Sicor's
finished dosage vecuronium sufficient to meet *** of Baxter PPI's *** for such
product after Baxter PPI has fulfilled its minimum purchase obligations under
its contracts with other suppliers for such product existing as of the date of
this Amendment.
--------
*** Confidential material redacted and separately filed with the Commission.
Page 2
2.12 CO-PROMOTION. Gensia Sicor shall have the right, but not the
obligation, to co-promote, at its sole cost and expense, any Products in the
Territory during the term of the Agreement. All pricing shall be determined by
Baxter PPI. Any co-marketing efforts to create a private label with wholesalers
will be a collaborative effort with Baxter PPI.
2.13 OPTION TO DISCONTINUE PRODUCT. In the event that the sum of the Per
Unit Material Cost and applicable Variable Standard Costs for Products *** of
the *** due to future reductions in contract pricing after the date of this
Amendment, then Gensia Sicor may elect to discontinue manufacturing said Product
upon ninety days (90) written notice; provided, however, Baxter PPI may continue
to purchase said Products and Gensia Sicor shall manufacture them at Baxter
PPI's option for up to a two year period at the previous period Transfer Price
or until Baxter PPI locates another source for said Products.
3. Sections 5.1, 5.2 and 5.3 of the Agreement shall be deleted and replaced
in their entirety with the following:
5.1 TRANSFER PRICE. The price for each Product presentation ("Transfer
Price"), other than Vecuronium, Hetastarch and Propofol, to be delivered to
Baxter PPI by Gensia Sicor during the term of this Agreement shall be the sum of
the applicable *** for each Product presentation and the applicable Variable
Standard Cost; provided such sum does *** on the Premier Purchasing Partners
Contract as set forth in Exhibit C hereto; provided the transfer price for
Diltiazem 5ml and 10ml shall *** respectively except as set forth in Section
5.2. For Vecuronium the Transfer Price shall be the *** for each presentation;
provided such sum does *** on the Premier Purchasing Partners Contract as set
forth in Exhibit C hereto. Baxter PPI shall pay to Gensia Sicor an amount equal
to the quantities of each Product presentation delivered to Baxter PPI
multiplied by the applicable Transfer Price for such Product presentation. The
terms of payment are net thirty (30) days from date of invoice which invoice
shall not predate the shipment of Products.
5.2 ADJUSTMENTS TO TRANSFER PRICE. Except as otherwise noted, set forth
on Exhibit C is a calculation by Gensia Sicor of the Per Unit Materials Cost
for each Product presentation *** Variable Standard Costs and the Full
Standard Costs (for Vecuronium), together with the resulting Transfer Price
based on the calculation in Section 5.1 hereof. The Per Unit Materials Cost,
the Variable Standard Costs, and the Full Standard Costs shall be adjusted at
the beginning of each Annual Period during the term of this Agreement. A Per
Unit Materials Cost reduction in the Diltiazem 5ml and 10ml product shall be
reflected as a reduction in the Transfer Price set forth in Section 5.1.
Gensia Sicor shall provide written notice of such adjustment thirty (30) days
prior to the date of the adjustment. Such adjustment will be based on the
then current actual invoice costs of Materials used to manufacture and
package products to be delivered to Baxter PPI, the actual Variable Standard
Costs and the actual Full Standard Costs during the applicable period.
5.3 ROYALTY. In addition to the Transfer Price, for each Product
presentation detailed in Section 5.1 hereof other than Hetastarch, Propofol and
Transition Period Product sales to Contracted Customers, Baxter PPI will pay to
Gensia Sicor a Royalty ("Royalty") *** of the *** on Products delivered by
Gensia Sicor and sold by Baxter PPI in the Territory. With respect to
--------
*** Confidential material redacted and separately filed with the Commission.
Page 3
contracts with Contracted Customers which are assigned to Baxter PPI pursuant to
Section 2.8 hereof, Baxter PPI will pay a Royalty *** of the *** on Products
delivered by Gensia Sicor and sold by Baxter PPI to Contracted Customers through
December 31, 1999, after which the Royalty will be *** for calendar year 2000
and *** for each year thereafter. In the event Gensia Sicor's co-marketing
efforts produces a private label agreement with a drug wholesaler, then Baxter
PPI will pay to Gensia Sicor a Royalty *** of the *** on private labeled
Products delivered by Gensia Sicor and sold by Baxter PPI to such drug
wholesaler. Baxter PPI will provide payment to Gensia Sicor on a quarterly basis
not more than sixty (60) days following the end of each of the first three (3)
quarters of an Annual Period. Each payment shall be accompanied by a statement
showing the Net Sales for the applicable quarter and the calculation of the
Royalty set forth herein.
4. Exhibits A and C to the Agreement shall be deleted and replaced in their
entirety with the Exhibits A and C attached to this Amendment.
5. 6.1 Term and Renewal. Section 6.1 shall be amended to extend the initial
term to December 31, 2004.
6. Except as specifically set forth above, the Amendment to the Agreement
contained herein shall be effective as of the date hereof and all other terms
and conditions set forth in the Agreement shall remain unchanged.
7. Capitalized terms not otherwise defined herein shall have the
meaning ascribed to them by the Agreement.
IN WITNESS WHEREOF the parties hereto have executed this Amendment as of the
date first above written.
GENSIA SICOR PHARMACEUTICALS, INC. XXXXXX PHARMACEUTICAL PRODUCTS INC.
By: /S/ XXXXXXX X. XXXXXX By: /S/ XXXXXX X. XXXXXXX
-------------------------------- -----------------------------------
Name: Xxxxxxx X. Xxxxxx Name: Xxxxxx X. Xxxxxxx
Title: President Title: Vice President & General
Manager
----------
*** Confidential material redacted and separately filed with the Commission.
Page 4
EXHIBIT A
--------------------------------------------------------------------------------
PRODUCT FILL/VIAL SIZE CATALOGUE #
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
atropine 0.4mg/ml 1 ml/2 ml 2501-0401
--------------------------------------------------------------------------------
atropine 0.4mg/ml 20 ml 2525-0301
--------------------------------------------------------------------------------
atropine 1.0 mg/ml 1 ml/2 ml 2511-0401
--------------------------------------------------------------------------------
atracurium besylate inj. 10 mg/ml 5 ml 2643-03
--------------------------------------------------------------------------------
atracurium besylate inj. 10 mg/ml 10 ml 2644-03
--------------------------------------------------------------------------------
bumetanide 0.25 mg/ml 2 ml 5062-0301
--------------------------------------------------------------------------------
bumetanide 0.25 mg/ml 4 ml/5 ml 5063-0301
--------------------------------------------------------------------------------
bumetanide 0.25 mg/ml 10 ml 6064-0301
--------------------------------------------------------------------------------
diltiazem 5 mg/ml 5 ml 1553-03
--------------------------------------------------------------------------------
diltiazem 5 mg/ml 10 ml 1554-03
--------------------------------------------------------------------------------
hetastarch 6% in 0.9% NaCl 500 ml 12 pack 5079-07
--------------------------------------------------------------------------------
metoclopramide 2 ml 4502-0401
--------------------------------------------------------------------------------
neostigmine 1 mg/ml 10 ml 2704-0302
--------------------------------------------------------------------------------
neostigmine 0.5 mg/ml 1 ml/2 ml 2711-0302
--------------------------------------------------------------------------------
neostigmine 0.5 mg/ml 10 ml 2714-0302
--------------------------------------------------------------------------------
pancuronium 1 mg/ml 10 ml 2804-0301
--------------------------------------------------------------------------------
pancuronium 2 mg/ml 2 ml 2812-0401
--------------------------------------------------------------------------------
pancuronium 2 mg/ml 5 ml 2823-0401
--------------------------------------------------------------------------------
phenylepherine 2 ml 1631-0401
--------------------------------------------------------------------------------
sodium nitroprusside 2 ml 1802-0101
--------------------------------------------------------------------------------
thiopental 1 gm kit 2530-0101
--------------------------------------------------------------------------------
thiopental 2.5 gm kit 2540-0101
--------------------------------------------------------------------------------
thiopental 5.0 gm kit 2550-0101
--------------------------------------------------------------------------------
thiopental 500 mg syringe kit 2580-0101
--------------------------------------------------------------------------------
vecuronium 10 mg 10 ml 2914-0301
--------------------------------------------------------------------------------
vecuronium 20 mg 20 ml 2925-0301
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Page 5
EXHIBIT B
FINISHED PRODUCT SPECIFICATIONS AND DATA SHEET
(ATTACHED)
Page 6
EXHIBIT C
***
----------
***Two pages of confidential material redacted and separately filed with the
Commission.
Page 7
ASSIGNMENT AND ASSUMPTION AGREEMENT
ASSIGNMENT AND ASSUMPTION AGREEMENT (this "Agreement"),dated as of October
7, 1998, is by and between GENSIA SICOR PHARMACEUTICALS, INC., a Delaware
corporation ("GENSIA SICOR") and XXXXXX PHARMACEUTICAL PRODUCTS INC., a Delaware
corporation ("BAXTER PPI"). Capitalized terms used herein but not defined herein
shall have the meanings ascribed to them in the Amendment (as hereinafter
defined).
WHEREAS, Gensia Sicor and Baxter PPI have entered into an Amendment to
Manufacturing & Distribution Agreement dated as of September __, 1998 (the
"AMENDMENT") pursuant to which, among other things, Gensia Sicor has agreed to
assign to Baxter PPI and Baxter PPI has agreed to assume, certain contracts
between Gensia Sicor and its Contracted Customers in effect as of the date
thereof.
NOW, THEREFORE, for good and valuable consideration, the receipt and
sufficiency of which is hereby acknowledged, and pursuant to the Amendment, the
parties hereto agree as follows:
1. SALE AND ASSIGNMENT OF ASSETS. Gensia Sicor does hereby sell, assign,
transfer, convey and deliver to Baxter PPI, and Baxter PPI does hereby purchase
and acquire from Gensia Sicor, all of Gensia Sicor's right, title and interest
in and to the contracts or those provisions of such contracts listed on EXHIBIT
A hereto, including all of the properties, rights and claims relating thereto;
PROVIDED, HOWEVER, as to any such contract which cannot be sold, assigned,
transferred, conveyed or delivered effectively without the consent of a third
party, which consent has not been obtained, this Agreement shall be of no force
or effect until such requisite consent is obtained, whereupon this Agreement
shall become of full force and effect with respect thereto.
2. ASSUMED LIABILITIES. Baxter PPI hereby assumes and agrees to pay,
perform and discharge when due, any and all debts, liabilities and obligations
with respect to the contracts listed on EXHIBIT A hereto which are to be paid or
performed after the later of the date hereof and the effective assignment of any
such contract (the later of such dates being referred to herein as the
"EFFECTIVE DATE"), except to the extent that any such debts, liabilities and
obligations relate to periods prior to the Effective Date or result from the
negligent act or omission of Gensia Sicor or a breach by Gensia Sicor of any of
the terms and conditions of the contracts listed on Exhibit A hereto.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed as of the day and year first above written.
GENSIA SICOR PHARMACEUTICALS, INC.
By: /s/ Xxxxxxx X. Xxxxxx
---------------------------------
Name: Xxxxxxx X. Xxxxxx
Title: President
XXXXXX PHARMACEUTICAL PRODUCTS INC.
By: /S/ XXXXXX X. XXXXXXX
---------------------------------
Name: Xxxxxx X. Xxxxxxx
Title: Vice President & Gen.
Manager
CONFIDENTIAL
Exhibit A (Partial List)
COMPANY CONTRACT# Contract Exp. NDC# Description
***
----------
*** Five pages of confidential material redacted and separately filed with
the Commission.
Page 1 of 1
AMENDMENT TO MANUFACTURING & DISTRIBUTION AGREEMENT
THIS THIRD AMENDMENT (the "Amendment"), dated as of December 23, 1998,
amends that certain Manufacturing & Distribution Agreement by and between GENSIA
SICOR PHARMACEUTICALS, INC. ("Gensia Sicor") (formerly Gensia Laboratories,
Ltd.), a Delaware Corporation, and XXXXXX PHARMACEUTICAL PRODUCTS INC. ("Baxter
PPI") (formerly Ohmeda Pharmaceutical Products Division Inc.), a Delaware
Corporation, dated February 27, 1996, as amended (the "Agreement").
1. Sections 2.6 and 2.12 of the Agreement shall be deleted and replaced in
their entirety with the following:
2.6 DELIVERY TERMS. Gensia Sicor agrees to deliver Product(s) manufactured
in California to Baxter PPI - F.O.B. Gensia Sicor's plant in Irvine, California
or other U.S. Gensia Sicor designated location. For Hetastarch, Gensia Sicor
agrees to deliver Product(s) to Baxter PPI, in Memphis, Tennessee - CIP.
Incoterms 1990 shall apply. Product(s) shall be shipped by Gensia Sicor
according to Baxter PPI's instructions and in conformance with all requirements
set forth in the Product labeling.
2.12 GO-PROMOTION. Gensia Sicor shall have the right, but not the
obligation, to co-promote, at its sole cost and expense, any Product(s) in the
Territory during the term of the Agreement. All pricing shall be determined by
Baxter PPI. Except for Propofol and Hetastarch, any co-promotion efforts to
create a private label with wholesalers will be a collaborative effort with
Baxter PPI.
2. Sections 5.3 and 5.5 of the Agreement shall be deleted and replaced in
their entirety with the following:
5.3 ROYALTY. In addition to the Transfer Price, (i) for each Product
presentation detailed in Section 5.1 hereof other than Hetastarch, Propofol and
Transition Period Product sales to Contracted Customers, Baxter PPI will pay to
Gensia Sicor a Royalty ("Royalty") *** of the *** on Products delivered by
Gensia Sicor and sold by Baxter PPI in the Territory; (ii) for Transition Period
sales to Contracted Customers which are assigned to Baxter PPI pursuant to
Section 2.8 hereof, Baxter PPI will pay a Royalty *** of the *** on Products
delivered by Gensia Sicor and sold by Baxter PPI to Contracted Customers through
December 31, 1999, after which the Royalty will be *** for calendar year 2000
and *** for each year thereafter; (iii) for Hetastarch Baxter PPI shall pay a
Royalty *** of the *** on Hetastarch delivered by Gensia Sicor and sold by
Baxter PPI in the territory; and (iv) in the event Gensia Sicor's co-promotion
efforts pursuant to Section 2.12 hereof result in a private label agreement,
excluding Hetastarch and Propofol, with a drug wholesaler, then Baxter PPI will
pay to Gensia Sicor a Royalty equal to sixty percent (60%) of the Gross Margin
on private label Products delivered by Gensia Sicor and sold by Baxter PPI to
such drug wholesaler. Baxter PPI will provide payment to Gensia Sicor on a
quarterly basis not more than sixty (60) days following the
----------
*** Confidential material redacted and separately filed with the Commission.
Page 1
end of each of the first three (3) quarters of an Annual Period. Each payment
shall be accompanied by a statement showing the Net Sales for the applicable
quarter and the calculation of the Royalty set forth herein.
5.5 HETASTARCH.
(a) The initial Hetastarch purchase price ("Initial Hetastarch
Purchase Price"), shown in the Transfer Price column of Exhibit C, payable
by Baxter PPI to Gensia Sicor for each unit of Hetastarch to be delivered
during the fourth quarter of 1998 and the first quarter of 1999 shall be
***. For the balance of the Term of this Agreement the purchase price is
set forth in Section 5.5 (b) below.
(b) For invoicing purposes, after the expiration of the Initial
Hetastarch Purchase Price set forth in 5.5(a) above, the parties shall set
a new per unit Hetastarch Purchase Price at the beginning of each quarter
as set forth below. The Hetastarch Purchase Price ("Hetastarch Purchase
Price") payable by Baxter PPI to Gensia Sicor for each unit of Hetastarch
to be delivered during the Term following the expiration of the Initial
Hetastarch Purchase Price set forth in Section 5.5(a) above shall be the
***, as determined quarterly. Gensia Sicor's Landed Cost as set forth in
the Sum of Material Costs and Variable Standard Costs per unit column in
Exhibit C shall be defined as the *** for Hetastarch for the purposes of
Royalty calculation for Hetastarch. The most recently available *** and
the *** as defined in this Section shall be used to estimate the Royalty
payable. The terms of payment are net thirty (30) days from the date of
the invoice.
(c) The total price payable to Gensia Sicor shall be the Transfer
Price for Hetastarch as set forth in Section 5.5 (b) and a Royalty *** of
the *** on Hetastarch delivered by Gensia Sicor and sold by Baxter PPI in
the territory. Baxter PPI will provide payment to Gensia Sicor on a
quarterly basis not more than sixty (60) days following the end of each of
the first three (3) quarters of an Annual Period. Each payment shall be
accompanied by a statement showing the Net Sales for the applicable
quarter and the calculation of the Royalty set forth herein. Baxter PPI
shall provide an Annual Reconciliation and Adjustment under the terms of
Section 5.4 adjusted for the Hetastarch Purchase Price paid in calculating
the final total payment of Royalty due Gensia Sicor.
(d) Baxter PPI may return Hetastarch units damaged for credit
(determined as set forth below). Baxter PPI may return short dated
Hetastarch with a Gensia Sicor label to Gensia Sicor for credit only if
Baxter PPI has used commercially reasonable efforts to sell such units.
The credit per unit to Baxter PPl shall be equal to the Hetastarch
Purchase Price per unit (as defined in Section 5.5 (a) & (b) above). For
the purposes of this Section 5.5, "shortdated" shall mean having less than
six (6) months shelf life remaining. Short dated or expired Hetastarch in
a Baxter label is not returnable to Gensia Sicor for credit.
----------
*** Confidential material redacted and separately filed with the Commission.
Page 2
(e) Baxter PPI agrees to purchase and handle the total distribution
and selling of Hetastarch that has been manufactured and labelled with a
Gensia Sicor label as of the date of this Amendment as if it were Baxter
labelled product All future Hetastarch production will be in a Baxter
label. Gensia Sicor agrees to provide all licenses and approvals required
to distribute Hetastarch in Gensia Sicor's label.
(f) In the event that the "Average Selling Price" (defined as Net
Sales divided by the number of units sold in the period) for units of
Hetastarch drops below $*** during any quarterly reporting period
hereunder, then the parties shall renegotiate the purchase price payable
to Gensia Sicor for units of Hetastarch on a basis satisfactory to both
parties.
3. Exhibit C to the Agreement shall be deleted and replaced in their entirety
with the Exhibit C attached to this Amendment.
4. Section Sixteen of the Agreement shall be deleted and replaced in its
entirety with the following:
16. NOTICES. Any notice or request expressly provided for or permitted
under this Agreement shall be in writing, delivered manually or by mail,
telegram, telefax or cable and shall be deemed sufficiently given if and when
received by the party to be notified at its address first set forth below, or if
and when mailed by registered mail or certified mail, postage prepaid, addressed
to such party at such address. Either party, by notice to the other, may change
its address for receiving such notices.
To Gensia Sicor: Gensia Sicor, Inc.
00 Xxxxxx
Xxxxxx, XX 00000-0000
Attention: President and Chief Operating Officer
with copy to: Gensia Sicor, Inc.
00 Xxxxxx
Xxxxxx, XX 00000-0000
Attention: General Counsel
To Baxter PPI: Xxxxxx Pharmaceutical Products Inc.
000 Xxxxx Xxxx, XX Xxx 000
Xxxxxxx Xxxxxx, XX 00000
Attention: Vice President and General Manager
----------
*** Confidential material redacted and separately filed with the Commission.
Page 3
with copy to: Xxxxxx Healthcare Corp.
One Deerfield Parkway (DF 3-2E)
Xxxxxxxxx, XX 00000
Attention: Senior Counsel/Baxter PPI
5. Schedule 5.5 of the Agreement is hereby deleted.
6. Except as specifically set forth above, this Amendment shall be effective
as of the date hereof and all other terms and conditions set forth in the
Agreement shall remain unchanged.
7. Capitalized terms not otherwise defined herein shall have the meaning
ascribed to them by the Agreement.
IN WITNESS WHEREOF, the parties hereto have executed this Amendment as of the
date first above written.
GENSIA SICOR XXXXXX PHARMACEUTICAL
PHARMACEUTICALS, INC. PRODUCTS INC.
By /s/ Xxxxxxx Xxxxxx By /s/ Xxxxxx X. Xxxxxxx
------------------------ ---------------------------------
Name: Xxxxxxx Xxxxxx Name: Xxxxxx X. Xxxxxxx
------------------------ ---------------------------------
Title: President Title: Vice President & Gen. Manager
------------------------ --------------------------------
Page 4
EXHIBIT C
***
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Commission.
Page 5
AMENDMENT TO MANUFACTURING & DISTRIBUTION AGREEMENT
THIS FOURTH AMENDMENT (the "Amendment"), dated as of March 22, 1999,
amends that certain Manufacturing & Distribution Agreement by and between GENSIA
SICOR PHARMACEUTICALS, INC. ("Gensia Sicor") (formerly Gensia Laboratories,
Ltd.) and XXXXXX PHARMACEUTICAL PRODUCTS INC. ("Baxter PPI") (formerly Ohmeda
Pharmaceutical Products Division Inc.) dated as of February 27, 1996, as amended
(the "Agreement").
1. The recitals of the Agreement shall be deleted and replaced in their
entirety with the following:
WHEREAS, Gensia Sicor manufactures, packages, sells, markets and
distributes certain anesthesia related pharmaceutical products;
WHEREAS, Baxter PPI manufactures, packages, sells, markets and distributes
a range of anesthesia-related intravenous and inhalation products and devices;
WHEREAS, both Gensia Sicor and Baxter PPI believe that each of them and
their respective customers would benefit by formation of a collaborative
manufacturing, sales, marketing and distribution effort;
WHEREAS, Baxter PPI desires to distribute Gensia Sicor manufactured
products under a Baxter label and include such products in Baxter PPI "risk
sharing" programs;
WHEREAS, Gensia Sicor is willing to manufacture and supply such products
for Baxter PPI pursuant to the terms and conditions set forth herein;
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NOW, THEREFORE, in consideration of the mutual promises contained in this
Agreement, and for other good and valuable consideration the parties hereto
agree as follows:
2. Section 1.2 of the Agreement shall be deleted and replaced in its entirety
with the following:
1.2 "ANDA" shall mean (a) the Abbreviated New Drug Application for any of
the Products which has been submitted to the FDA, including any amendments or
supplements thereto; and (b) any Abbreviated New Drug Application for propofol
which has been submitted to the FDA, including any amendments or supplements
thereto.
1.2.1 "NDA" shall mean any New Drug Application for any propofol
emulsion in the same or similar presentations and formulations described in
Exhibit C attached hereto submitted to the FDA, by Baxter PPI or its Affiliates,
including any amendments or supplements thereto (provided that Gensia Sicor
shall agree to reimburse Baxter PPI for *** of the out-of-pocket costs incurred
by Baxter PPI in the submission of such New Drug Application in excess of those
out-of-pocket costs customarily incurred in the submission of an Abbreviated New
Drug Application).
3. Section 1.6 of the Agreement shall be amended to add the following new
Section 1.6.1 immediately following the end thereof:
1.6.1 ***
4. Sections 1.8 and 1.12 of the Agreement shall be deleted and replaced in
their entirety with the following:
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1.8 "Net Sales" shall mean actual invoiced sales of the Product(s) by
Baxter PPI or its Affiliates to third parties (that are not Affiliates), subject
to adjustment in accordance with Section 15 regarding "risk sharing" agreements,
less the following:
(i) allowances for discounts or rebates, chargebacks, or buying
group administration fees reasonably allocable to such sales of
Product(s);
(ii) returns, recalls, credits or allowances, if any, given or made;
(iii) sales, use, value-added or other excise taxes, if any, imposed
on the sale by any governmental entity; and
(iv) freight and insurance costs incurred in transporting Product(s)
to Baxter PPI's distribution center in Memphis, Tennessee or to such other
distribution center in the Territory as may be designated by Baxter PPI.
(v) deductions for returns, Section 1.8(iv) freight and insurance,
cash terms payable to wholesalers and distributors, and allowable buying
group administration fees shall be ***.
1.12 "Territory" shall mean the United States of America and its
territories and possessions, including the Commonwealth of Puerto Rico but shall
exclude customers known to Baxter PPI to have an intent to export the Product(s)
outside the Territory.
5. Section One of the Agreement shall be amended to add the following new
section after Section 1.16:
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1.17 "Propofol" shall mean propofol for human use in a finished product
formulation with an approved ANDA or NDA in the Territory.
6. Section 2.4 of the Agreement shall be amended to add the following new
Section 2.4.1 immediately following the end thereof:
2.4.1 Propofol Demand Schedule. Notwithstanding the foregoing, Baxter PPI
shall provide forecasts and orders for Propofol presentations as follows:
(a) Commencing on April 1, 1999, in each Demand Schedule provided
hereunder, Baxter PPI shall provide Gensia Sicor with a good faith twelve (12)
month forecast of its requirements for each presentation of Propofol. The first
three (3) months forecasted requirements for Propofol presentations in each of
the Demand Schedules required to be provided on April 1 and May 1, 1999, shall
constitute firm purchase orders. Commencing with the Demand Schedule required to
be provided on May 1, 1999, the first two (2) months forecasted requirements for
Propofol presentations in each Demand Schedule shall reflect Baxter PPI's firm
purchase orders therefor communicated by previous Demand Schedules, and a firm
purchase order for the next succeeding (third) month forecasted requirements for
Propofol presentations in each Demand Schedule.
(b) Baxter PPI shall be obligated to purchase one hundred percent
(100%) of each firm purchase order. Baxter PPI shall be obligated to purchase
not less than the following percentages of each Propofol presentation forecasted
for the following months in the Demand Schedule provided by Baxter PPI to Gensia
Sicor for the first month of any calendar quarter during the term of this
Agreement:
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***
(c) Gensia Sicor shall not be obligated to supply more than *** of
the aggregate units of each Propofol presentation forecasted for any month (a)
for each of months *** of the Demand Schedule required to be provided by Baxter
PPI to Gensia Sicor on April 1, 1999, and (b) for the twelfth (12th) month of
each Demand Schedule provided thereafter. Gensia Sicor will use commercially
reasonable efforts to supply sufficient quantities of Products above such
amounts to accommodate changing demand patterns in the market place.
(d) Notwithstanding anything in this Agreement to the contrary, and
notwithstanding any contractual or other commitments made by Baxter PPI to its
customers, Gensia Sicor shall not be obligated to deliver Propofol presentations
to Baxter PPI in excess of Gensia Sicor's manufacturing capacity at such time.
Gensia Sicor estimates, based on projected capital expenditures in accordance
with the capital spending plan previously disclosed to Baxter PPI, such
manufacturing capacity to be, over a period of any four (4) consecutive calendar
quarters, (a) *** of Propofol per year, for calendar quarters up to an including
the quarter ending March 31, 2000; (b) ***, for the five (5) calendar quarters
beginning April 1, 2000 up to and including the quarter ending June 30, 2001;
and (c) ***, for calendar quarters beginning July 1, 2001. Each lot of Propofol
shall comprise that number of units of Propofol presentations that is produced
from a lot of not less than 1500 liters of bulk propofol emulsion.
7. Sections 2.7 of the Agreement shall be amended to add the following new
Sections 2.7.1 and 2.7.2 immediately following the end thereof:
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2.7.1 PROPOFOL NON-HUMAN-USE. Notwithstanding the foregoing, Gensia Sicor
retains the exclusive right to market and sell propofol which is manufactured
using Gensia Sicor's technology for non-human use in the Territory.
2.7.2 PROPOFOL NON-COMPETITION. Except as otherwise permitted under this
Agreement, Baxter PPI shall not, and shall not grant any license or other right
to any third party to, sell or distribute in the Territory Propofol in the same
or similar presentations and formulations as those described in Exhibit C
hereto, for so long during the term of this Agreement as Baxter PPI remains
Gensia Sicor's exclusive distributor for Propofol in the Territory.
8. Sections 2.8 of the Agreement shall be amended to add the following new
Section 2.8.1 immediately following the end thereof:
2.8.1 PROPOFOL AND THE TRANSITION PERIOD. The provisions of Section 2.8
shall not apply to Propofol.
9. Sections 2.9, 2.10, 2.11 and 2.12 of the Agreement shall be deleted and
replaced in their entirety with the following new three sections:
2.9 BULK ATRACURIUM BESYLATE SUPPLY. Upon approval of a Baxter PPI ANDA
supplement qualifying bulk atracurium besylate from an Affiliate of Gensia
Sicor, Baxter PPI agrees to purchase bulk atracurium besylate from an Affiliate
of Gensia Sicor annually in an aggregate amount sufficient to meet *** of the
combined annual aggregate volumes of atracurium besylate as of March 22, 1999 to
meet Baxter PPI's and Gensia Sicor's generic product
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requirements for bulk atracurium besylate in the Territory, at a purchase price
***. Baxter PPI agrees to use commercially reasonable efforts to pursue such
ANDA supplement through to approval. Atracurium may be produced in a Gensia
Sicor label for human use until Baxter PPI takes its first delivery of bulk
atracurium besylate from a Gensia Sicor Affiliate. If, at the end of any
calendar year during the term of this Agreement, it is determined that the total
aggregate kilogram equivalent of all atracurium besylate injection products sold
by all parties in the United States during such calendar year, as reported by
IMS, changes from the total aggregate sold by all parties in the United States
for calendar year 1998, as reported by IMS, then Baxter PPI shall adjust
proportionately its minimum requirements for the following calendar year for
purchases of bulk atracurium besylate from an Affiliate of Gensia Sicor by an
amount equal to the percent change in the aforementioned total aggregate sales
by all parties.
2.10 BAXTER PPI PURCHASE OBLIGATIONS.
2.10.1 DILTIAZEM. Baxter PPI agrees to purchase Gensia Sicor's
finished dosage diltiazem sufficient to meet *** for diltiazem in the Territory
after Baxter PPI has fulfilled its minimum purchase obligations under its
contracts with other suppliers for such product existing as of October 7, 1998.
2.10.2 VECURONIUM. Baxter PPI agrees to purchase Gensia Sicor's
finished dosage vecuronium sufficient to meet *** for vecuronium in the
Territory.
2.10.3 HETASTARCH. Baxter PPI agrees to purchase Gensia Sicor's
finished dosage hetastarch sufficient to meet *** for hetastarch in the
Territory.
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2.10.4 PROPOFOL. Baxter PPI agrees to purchase Gensia Sicor's
finished dosage Propofol sufficient to meet *** for Propofol in the Territory.
2.11 CO-PROMOTION. Gensia Sicor shall have the right, but not the
obligation, to co-promote, at its sole cost and expense, any Product(s) in the
Territory during the term of the Agreement. All pricing shall be determined by
Baxter PPI. Except for Propofol and hetastarch, any co-promotion efforts to
create a private label with wholesalers will be a collaborative effort with
Baxter PPI.
10. Section 2.13 of the Agreement shall be renumbered to be Section 2.12 and
shall be amended to add the following new section immediately following the end
thereof:
2.12.1 OPTION TO DISCONTINUE PRODUCT. Notwithstanding the foregoing, if
the Transfer Price set forth on Exhibit C hereto for any presentation of
diltiazem, the Full Standard Cost for any presentation of vecuronium, the Landed
Cost for any presentation of hetastarch, or *** for any presentation of Propofol
*** (if any) for such Product presentation set forth on Exhibit C hereto, then
subject to the immediately following sentence, Gensia Sicor shall have the right
(at its option, in its sole discretion) to terminate this Agreement as to such
Product presentation on ninety (90) days prior written notice to Baxter PPI. If
Gensia Sicor elects to terminate this Agreement as to any such Product
presentation, then Baxter PPI shall have the right, which may be exercised only
by written notice to Gensia Sicor within thirty (30) days after Baxter PPI's
receipt of the termination notice from Gensia Sicor, to continue this Agreement
as to such Product presentation for a period (the "Continuation Period") of up
to one (1) year after the date of Gensia Sicor's
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receipt of the continuation notice from Baxter; provided, however, that (a)
during the Continuation Period with respect to any such Product presentation,
Gensia Sicor shall not be obligated to deliver to Baxter PPI more than the
quantity of such Product presentation ordered in good faith by Baxter PPI as
necessary to satisfy its requirements under those contracts of Baxter PPI
existing and in effect as of the date of Baxter PPI's receipt of the termination
notice under this Section 2.12.1; and (b) if such termination is with respect to
all Propofol presentations, the technology licenses granted under Section 2.13.1
shall terminate.
2.13 PROPOFOL SUPPLY.
2.13.1 PROPOFOL TECHNOLOGY LICENSE. Subject to the terms and
conditions of this Agreement, during the term of this Agreement (as such term
applies to Propofol), Gensia Sicor and Baxter PPI each hereby grants to the
other an exclusive license (exclusive even as to Baxter PPI in the case of the
license granted to Gensia Sicor, but not exclusive as to Gensia Sicor in the
case of the license granted to Baxter PPI, for the sole purpose of enabling
Gensia Sicor to manufacture and supply Propofol to Baxter PPI hereunder), with
the right to sub-license solely to their respective Affiliates, under its and
its Affiliates' rights in (i) present and future ANDAs or NDAs for propofol in
the same or similar presentations and formulations described in Exhibit C
attached hereto, and (ii) the patent rights, know how and other intellectual
property rights in the Territory necessary to manufacture, use and sell Propofol
in the Territory by the methods disclosed in such ANDAs or NDAs, for the sole
purpose of making Propofol in the Territory for use, offer for sale and sale in
the Territory. Notwithstanding the foregoing, each party reserves the exclusive
right to manufacture Propofol using its own technology in the Territory for use,
offer for sale and sale outside the Territory.
2.13.2 COOPERATION. Baxter PPI shall reasonably cooperate with
Gensia Sicor in addressing technical, regulatory and clinical issues related to
the manufacture of Propofol. Without
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limiting the generality of the foregoing, at the reasonable request of Gensia
Sicor, Baxter PPI shall make available to Gensia Sicor information regarding the
status of Baxter PPI's Propofol ANDA or NDA (as the case may be) and any
technology, or know-how in its possession relating to the manufacture of
Propofol. Baxter PPI shall make its employees and agents reasonably available to
Gensia Sicor in connection with the cooperation and information sharing provided
for herein. Each party shall bear its own costs in connection with such
cooperation.
2.13.3 USE OF CERTAIN BULK MATERIAL. Gensia Sicor will use
commercially reasonable efforts to renegotiate its existing raw material supply
agreement for propofol bulk active drug substance to eliminate the exclusivity
provision therein. In the event Gensia Sicor is successful in eliminating such
provision, then Gensia Sicor shall purchase from Baxter PPI such quantity of
propofol bulk active drug substance as is in Baxter PPI's possession as of March
22, 1999 (the "Baxter Material"), and is required to meet Gensia Sicor's demand
for propofol bulk active drug substance in excess of commitments made by Gensia
Sicor to its existing supplier in effect as of March 22, 1999, subject to the
following conditions:
(a) Gensia Sicor shall determine in its sole discretion the number
of shipments, the intervals of such shipments, the quantities per shipment and
the reasonable delivery instructions for such shipments; provided, however, that
Gensia Sicor shall use its commercially reasonable efforts to take delivery of
Baxter Material as soon as reasonably practicable. The Baxter Material shall be
delivered to Gensia Sicor C.I.F. Gensia Sicor's designated location.
(b) Gensia Sicor shall have no obligation to purchase Baxter
Material to the extent such purchase would constitute a default under, or
otherwise conflict with, Gensia Sicor's existing raw material supply agreement
for propofol bulk active drug substance.
(c) Gensia Sicor shall have no obligation to purchase Baxter
Material that has less than six (6) months' dating remaining at the time of
receipt by Gensia Sicor hereunder.
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(d) Baxter PPI shall be responsible, at its sole expense, for
causing the manufacturer of the Baxter Material to maintain a current drug
master file with respect to the Baxter Material.
(e) Baxter shall reimburse Gensia Sicor for *** incurred by Gensia
Sicor in preparing and making all regulatory filings necessary to permit Gensia
Sicor to manufacture Propofol using the Baxter Material.
(f) For all Baxter Material received by Gensia Sicor which conforms
to the representations and warranties set forth in Section 2.13.3(g) below,
Gensia Sicor shall pay to Baxter PPI a price equal to Gensia Sicor's then
current cost of propofol bulk active drug substance from its current supplier.
(g) Xxxxxx PPI represents and warrants to Gensia Sicor that the
Xxxxxx Material (i) will conform to the specifications for propofol bulk active
drug substance set forth in Gensia Sicor's Propofol ANDA, (ii) has been
manufactured, stored and handled in compliance with GMP and in accordance with
all applicable laws and regulations, and (iii) is not adulterated or misbranded
within the meaning of the applicable section of the U.S. Food, Drug and Cosmetic
Act.
(h) Xxxxxx PPI shall indemnify and hold harmless Gensia Sicor, its
officers, directors, employees and agents, from all losses, liabilities, damages
and expenses (including reasonable attorneys' fees and costs) that they may
suffer or incur as a result of any claims, demands, actions or proceedings made
or instituted by any third party resulting from the use by Gensia Sicor of the
Xxxxxx Material.
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2.13.4 PROPOFOL MINIMUM PURCHASES. In the event aggregate sales of
Propofol to Xxxxxx PPI hereunder during any four (4) consecutive calendar
quarters beginning on or after January 1, 2000 are *** units for any reason
other than Force Majeure or Gensia Sicor's failure to deliver quantities of
Propofol ordered by Xxxxxx PPl in accordance with the terms of this Agreement
(and subject to the limitations of Gensia Sicor's supply obligations hereunder),
the Percentage Payment for Propofol payable to Gensia Sicor pursuant to Section
5.3.1 hereof shall be ***, commencing with the fifth such consecutive calendar
quarter and continuing thereafter until the first calendar quarter after the
aggregate sales of Propofol to Xxxxxx PPI hereunder during any four (4)
consecutive calendar quarters again ***. In the event that such Percentage
Payment *** continues for four (4) consecutive calendar quarters or more, Gensia
Sicor may, at its sole option in its sole discretion, reduce Xxxxxx PPI's
exclusive right under Section 2.7 hereof to market and sell Propofol to a
non-exclusive right to market and sell Propofol upon written notice thereof to
Xxxxxx PPI; provided, however, thereafter, (a) such Percentage Payment shall
***, and (b) the provisions of Sections 2.7 (with respect to Propofol only),
2.10.4, 2.13.1, 2.13.2 and 2.13.3 hereof shall terminate. Any election by Gensia
Sicor under this Section 2.13.4 shall not be exclusive of any other remedies
available to it for any breach by Xxxxxx PPI of any obligation hereunder.
2.13.5 PROPOFOL R&D PAYMENT. On or before March 31, 1999, in
consideration for entering into this Agreement, Xxxxxx PPI shall pay to Gensia
Sicor a fee of ***, as partial reimbursement for research and development
expenses of Gensia Sicor with respect to Propofol. In the event, and only in the
event, (a) Gensia Sicor becomes unable to manufacture Propofol due to an event
of Force Majeure (as defined in Section 11.1 below) occurring prior to December
31, 2001, and (b) the aggregate number of units of Propofol which Xxxxxx PPI
sold as of December 31, 2001 is ***, then within ninety (90) days thereafter,
Gensia Sicor shall refund to Xxxxxx PPI a
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*** Confidential material redacted and separately filed with the Commission.
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portion of the fee paid under this Section 2.13.5 equal to the product of (x)
such fee, times (y) the fraction equal to (i) *** less the aggregate number of
units of Propofol sold by Xxxxxx PPI as of December 31, 2001, divided by (ii)
***.
2.13.6 CERTAIN PROPOFOL LITIGATION.
(a) Xxxxxx PPI shall reimburse Gensia Sicor, on a monthly basis
within thirty (30) days after receipt of an invoice from Gensia Sicor, for an
amount, not to *** in the aggregate, *** of the reasonable and necessary
out-of-pocket expenses (including, without limitation, attorneys' fees and
costs), incurred by Gensia Sicor on or after February 5, 1999, in connection
with the defense of the litigation styled ZENECA INC. V. SHALALA, ET AL., Civil
Action No. WMN-99-307, pending in the United States District Court for the
District of Maryland (together with any appeals thereof). Xxxxxx PPI shall have
the right, upon reasonable notice and during normal business hours (and not more
than once in any six (6) calendar month period), to audit the financial records
of Gensia Sicor evidencing such out-of-pocket expenses. Gensia Sicor shall
furnish Xxxxxx PPI with copies of, and shall afford Xxxxxx PPI or its counsel a
reasonable opportunity to review and consult in advance with Gensia Sicor with
respect to, all pleadings and other filings in such litigation.
(b) With respect to any other action or other proceeding in the
Territory regarding the governmental approval to manufacture or sell, or the
bioequivalence of, Propofol filed by any third party against both Gensia Sicor
and Xxxxxx PPI, Gensia Sicor and Xxxxxx shall share, ***, the reasonable and
necessary out-of-pocket expenses (including, without limitation, attorneys' fees
and costs), incurred by Gensia Sicor or Xxxxxx PPI in connection with the
defense of such action or other proceeding (together with any appeals thereof);
provided, however, all out-of-
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pocket expenses incurred by either party in connection with the defense of bona
fide claims of the willful misconduct of a party (the "Responsible Party") shall
be the sole responsibility of the Responsible Party.
(c) With respect to any other action or other proceeding in the
Territory regarding governmental approval to manufacture or sell, or the
bioequivalence of, Propofol filed by any third party against only one party,
such party shall be solely responsible for all out-of-pocket expenses
(including, without limitation, attorneys' fees and costs), incurred by such
party in connection with the defense of such action or other proceeding
(together with any appeals thereof).
(d) If such action or other proceeding results in a final judgment
or settlement pursuant to which Gensia Sicor may not use its propofol ANDA or
NDA technology to manufacture and supply Xxxxxx PPI with Propofol hereunder,
then (i) Xxxxxx PPI and/or its designated third party contract manufacturer
shall retain the exclusive right to manufacture Propofol using Xxxxxx PPI
technology in the Territory; (ii) the provisions of Section 2.13.1 above shall
terminate; (iii) Gensia Sicor shall receive the Applicable Percentage (defined
below) of the Gross Margin based on sales by Xxxxxx PPI and its Affiliates to
end users of Propofol manufactured using Xxxxxx PPI technology other than by
Gensia Sicor hereunder; and (iv) Gensia Sicor shall be responsible for the
Applicable Percentage of the out-of-pocket expenses incurred by Xxxxxx PPI in
the promotion and marketing of Propofol during the first six (6) months after
the re-launch of Propofol manufactured using Xxxxxx PPI technology other than by
Gensia Sicor.
(e) For purposes of Section 2.13.6(d) above, the "Applicable
Percentage" shall mean the greater of (i) ***, or (ii) the remainder of (A) ***,
less (B) that *** to which Xxxxxx PPI would be entitled hereunder, based on
sales by Xxxxxx PPI and its Affiliates to end users of
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Propofol manufactured by Gensia Sicor hereunder, less (C) that percent of the
*** (in excess of the *** which Xxxxxx PPI is required to pay to a third party
manufacturer of Propofol using Xxxxxx PPI technology under Xxxxxx PPI's existing
supply agreement with such third party; provided, however, that for purposes of
this Section 2.13.6(e), Gross Margin shall be calculated using a cost of goods
equal to ***.
2.13.7 CERTAIN PROPOFOL PAYMENTS.
(a) If such action or other proceeding described in Section 2.14.6
above results in a final judgment or settlement pursuant to which a party or its
Affiliates receive any compensation, then such party shall pay to the other
party *** of the total compensation it and its Affiliates receive from third
parties within thirty (30) days of receipt of such compensation.
(b) If a party or its Affiliates sells, transfers, licenses or
otherwise grants rights to any third party under any of its propofol ANDA or NDA
technologies in the same or similar presentations and formulations as those
described in Exhibit C hereto, or such party or its Affiliates agrees with a
third party to delay or not to market under granted market exclusivity or to
delay or not pursue approval of any of its propofol ANDA or NDA technologies in
the same or similar presentations and formulations as those described in Exhibit
C hereto, then such party shall pay the other party *** of the total
compensation it and its Affiliates receive from third parties within thirty (30)
days of receipt of such compensation.
11. Section 3.9 of the Agreement shall be deleted and replaced in its entirety
with the following:
3.9 BATCH RECORDS. Records which include the information specific to the
manufacturing, packaging and quality operation for each lot of Product(s)
hereunder shall be
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prepared by the site of manufacture of such Product for each lot at the time at
which such operations occur. The records shall include, but are not limited to,
the following documentation: manufacturing, raw materials and components
charge-in records; mixing and fillings records; packaging component charge-in
records; packaging records; container and component traceability records;
in-process and final laboratory testing results; in-process and final Product(s)
physical inspection results; yield reconciliation for bulk and finished
Product(s); label samples; labeling control records; as well as documentation
listing any deviations and/or excursions from approved procedure (as well as all
investigations and corrective actions) incurred during the processing and
packaging of the lot. The original documents for each lot manufactured by Gensia
Sicor may be reviewed by Xxxxxx PPI at its request when auditing the sites of
manufacture of Product(s) or as reasonably requested by the Xxxxxx PPI site
quality representative when present at the facility during auditing or release
of Product(s) pursuant to Section 3.17 hereof.
12. Section 3.17 of the Agreement shall be deleted and replaced in its
entirety with the following:
3.17 AUDITS. Xxxxxx PPI shall have the right to station a reasonable
number of quality control personnel at the manufacturing facilities of Gensia
Sicor for the Products on substantially a full-time basis, when there is work
being conducted that relates to the Products, solely for the purpose of
performing quality assurance testing of Products and reviewing batch records
regarding Products. Such quality control personnel shall be subject to such
reasonable restrictions, as Gensia Sicor determines consistent with industry
practices and as are reasonable and necessary to preserve Gensia Sicor's
confidential information (in addition to those restrictions required by
applicable law or regulation), regarding access to those sections of the
manufacturing, packaging, laboratory and warehousing facilities utilized in, and
that information regarding, the manufacture, packaging,
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storage, testing, shipping or receiving of Products. Upon the written request of
Xxxxxx PPI and not more than once in each calendar year, Xxxxxx PPI shall have
the right, during normal business hours and on reasonable prior notice (which
notice shall be waived if circumstances warrant), to inspect those sections of
the manufacturing, packaging, laboratory and warehousing facilities utilized in
the manufacture, packaging, storage, testing, shipping or receiving of Products
solely for the purpose of (a) auditing compliance with GMP and applicable laws
and regulations regarding the manufacture of Products, and (b) inspecting
physical inventories of the excipient and active ingredients, the work in
process and finished goods of Products as well as all batch records as set forth
in Section 3.9.
13. Section 3 of the Agreement shall be amended to add the following new
section after Section 3.19 thereof:
3.20 REPROCESSING. Xxxxxx PPI shall have the right to approve, in advance
(which approval shall not be unreasonably withheld or delayed), the reprocessing
or any drug substance or the use of a reprocessed drug substance in Products
manufactured by Gensia Sicor on behalf of Xxxxxx PPI.
14. Section 4 of the Agreement shall be amended to add the following new
section after Section 4.7 thereof:
4.8 DEBARMENT. Each of Xxxxxx PPI and Gensia Sicor represent that it is
not debarred under the Generic Drug Enforcement Act of 1992 and that it does not
employ or use the services of any individual who is debarred or has engaged in
activity that could lead to debarment.
15. Section 5 of the Agreement shall be amended by deleting the term "Royalty"
in each place in which it appears and by inserting in lieu thereof the term
"Percentage Payment."
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16. Section 5.1 of the Agreement shall be amended to add the following new
Section 5.1.1 immediately following the end thereof:
5.1.1 PROPOFOL INVOICE PRICE. Notwithstanding the foregoing, Xxxxxx
PPI shall pay to Gensia Sicor an amount equal to the unit quantity of a specific
Propofol presentation delivered to Xxxxxx PPI by Gensia Sicor multiplied by the
applicable price (the "Propofol Invoice Price") for such presentation. The
initial Propofol Invoice Price payable by Xxxxxx PPI to Gensia Sicor is set
forth in the following table:
***
The initial Propofol Invoice Price shall be in effect through September 30,
1999. The terms of payment are net thirty (30) days from the date of the invoice
which invoice shall not predate the shipment of Propofol.
17. Section 5.2 of the Agreement shall be amended to add the following new
Section 5.2.1 immediately following the end thereof:
5.2.1 ADJUSTMENTS TO PROPOFOL INVOICE PRICE. Notwithstanding the
foregoing, not less than thirty (30) days prior to October 1, 1999, and not less
than thirty (30) days prior to the end of each calendar quarter thereafter
during the term of this Agreement, the parties shall set a new Propofol Invoice
Price as follows:
(a) Following the expiration of the initial Propofol Invoice Price,
the Propofol Invoice Price payable by Xxxxxx PPI to Gensia Sicor for any
presentation of Propofol delivered to
----------
*** Confidential material redacted and separately filed with the Commission.
-18-
Xxxxxx PPI by Gensia Sicor shall be calculated by adding the applicable Propofol
Transfer Price as set forth in Exhibit C hereto (as adjusted pursuant to Section
5.3.1(c) below) to *** of Gensia Sicor's share of the *** which the parties
reasonably estimate will be earned on sales of such presentation during the
subsequent calendar quarter.
(b) If the parties are unable to timely reach mutually acceptable
agreement under Section 5.2.1(a) above on the applicable Propofol Invoice Price
for any Propofol presentation for any calendar quarter, then the applicable
Propofol Invoice Price for such Propofol presentation for such calendar quarter
shall be calculated by adding the *** as set forth in Exhibit C hereto (as
adjusted pursuant to Section 5.3.1 (c) below) to *** of Gensia Sicor's share of
the *** (calculated based upon the *** of all sales of such Propofol
presentation during the preceding twelve (12) full calendar months to the *** of
such Propofol presentation during such twelve (12) full calendar month period).
18. Section 5.3 of the Agreement shall be amended to add the following new
Section 5.3.1 immediately following the end thereof:
5.3.1 PROPOFOL PERCENTAGE PAYMENT.
(a) Notwithstanding the foregoing, the total amount payable by
Xxxxxx PPI to Gensia Sicor shall be the Transfer Price as set forth in Exhibit C
(as adjusted pursuant to Section 5.3.1(c) below) and a Percentage Payment *** on
Propofol delivered by Gensia Sicor and sold by Xxxxxx PPI and its Affiliates in
the Territory (as such percentage is subject to adjustment pursuant to Section
2.13.4 above and to offset pursuant to Section 5.9 below). Xxxxxx PPI will
provide payment to Gensia Sicor on a quarterly basis not more than sixty (60)
days following the end of each quarter during the term of this Agreement.
----------
*** Confidential material redacted and separately filed with the Commission.
-19-
(b) For purposes of calculating the Percentage Payment for each
Propofol presentation, the Transfer Price for each Propofol presentation shall
be subject to adjustment after the earlier of (i) the date when Xxxxxx PPI has
purchased its ***unit of Propofol from Gensia Sicor, or (ii) December 31, 2000.
Commencing with the first calendar month beginning after such date, and at the
beginning of each calendar year thereafter, the Transfer Price for each Propofol
presentation shall be adjusted *** of Gensia Sicor's *** of such Propofol
presentation for such calendar year. Gensia Sicor shall provide written notice
of each such adjustment promptly following the determination thereof.
(c) Each payment shall be accompanied by a statement detailing the
Net Sales of Propofol for the applicable quarter by product presentation, the
calculation of the Percentage Payment earned as set forth herein, and a
reconciliation calculation detailing the total amount received by Gensia Sicor
and the Percentage Payment amount earned by Gensia Sicor during the applicable
period.
(d) In addition, at meetings between inventory personnel of the
respective parties (which shall not be less than quarterly), Xxxxxx PPI shall
report to Gensia Sicor the inventory on hand, by product presentation.
19. Section 5 of the Agreement shall be amended to add the following two new
sections after Section 5.8:
5.9 PROPOFOL PERFORMANCE INCENTIVE. Gensia Sicor shall allow Xxxxxx PPI a
new product launch incentive (the "Propofol Performance Incentive") for each
unit of Propofol sold by Xxxxxx PPI and its Affiliates to end users up to a
maximum number (the "Propofol Performance Target")
----------
*** Confidential material redacted and separately filed with the Commission.
-20-
of ***. The amount of the Propofol Product Incentive for each calendar year
during the term of this Agreement shall be (a) for calendar year 1999, ***; (b)
for calendar year 2000 and beyond, (i) *** in the event *** of Propofol were
sold by Xxxxxx PPI and its Affiliates to end users in calendar year 1999; (ii)
*** in the event *** of Propofol were sold by Xxxxxx PPl and its Affiliates to
end users in calendar year 1999; and (iii) *** in the event *** of Propofol were
sold by Xxxxxx PPI and its Affiliates to end users in calendar year 1999.
Notwithstanding the foregoing, (x) no Propofol Performance Incentive shall be
due on any unit of Propofol sold after an aggregate number of units of Propofol
equal to the Propofol Performance Target is sold by Xxxxxx PPI and its
Affiliates to end users and (y) in the event *** of Propofol were sold by Xxxxxx
PPI and its Affiliates to end users in calendar year 1999 solely because of
Gensia Sicor's inability to manufacture at *** of Propofol during calendar year
1999, the amount of the Propofol Product Incentive for calendar year 2000 and
beyond shall be ***. The Propofol Product Incentive for each calendar quarter
shall be offset against the Percentage Payment for Propofol owing to Gensia
Sicor for such calendar quarter. If, as of December 31, 2001, Xxxxxx PPI has
sold less than the Propofol Performance Target number of units of Propofol,
then, within ninety (90) days thereafter, as a further incentive for future
sales, Gensia Sicor shall advance to Xxxxxx PPI in cash the Propofol Performance
Incentive (at a rate of ***) for that number of units of Propofol less than the
Propofol Performance Target number of units which Xxxxxx PPI sold as of December
31, 2001; provided, however, if Gensia Sicor becomes unable to manufacture
Propofol due to an event of Force Majeure occurring prior to December 31, 2001,
and the aggregate number of units of Propofol which Xxxxxx PPI sold as of
December 31, 2001 is *** units, then for purposes of this Section 5.9 and
subject to the terms of Section 2.13.5
----------
*** Confidential material redacted and separately filed with the Commission.
-21-
above, the Propofol Performance Target shall be reduced to the aggregate number
of units of Propofol which Xxxxxx PPI sold as of December 31, 2001.
5.10 CONTRACTS. Xxxxxx PPI represents and warrants that, as of March 22,
1999, Propofol is included on group purchasing contracts as a sole source award
(or under terms and conditions that convert into a sole source award within
sixty (60) days after Xxxxxx labeled Propofol is available in the marketplace)
with hospital groups whose member hospitals purchase, in the aggregate, *** of
the IMS Hospital Audit reported sales for isoflurane. Xxxxxx PPI will use
commercially reasonable efforts to keep sufficient group purchasing contracts in
effect throughout the term of this Agreement to maintain *** of the IMS Hospital
Audit reported sales for isoflurane.
20. Section 6.1 of the Agreement shall be deleted and replaced in its entirety
with the following:
6.1 TERM AND RENEWAL. The obligation of the parties hereunder shall
commence on January 1, 1996 and continue for an initial period of nine (9)
Annual Periods and thereafter shall automatically be extended for additional one
(1) year terms, unless earlier terminated as provided herein. Each party may
terminate this Agreement upon two (2) years prior written notice.
21. Section 11.1 of the Agreement shall be deleted and replaced in its
entirety with the following:
11.1 FORCE MAJEURE. Neither party shall be liable to the other for default
or delay in the performance of its obligations under this Agreement, if such
default or delay shall be caused directly or indirectly by accident, fire,
flood, riot, war, act of God, embargo, strike, failure or delay
----------
*** Confidential material redacted and separately filed with the Commission.
-22-
of normal source of supply of materials, delay of carriers, governmental or
regulatory orders, applicable laws or regulations, or orders of any court of
competent jurisdiction (collectively, "Force Majeure"), provided same are not
due to the fault or neglect of such party and provided further that any such
delay or failure shall be remedied by such party as soon as possible after the
removal of the cause of such failure or delay.
22. The September, 1996 Addendum to this Agreement dated February 27, 1996,
and the attached Pricing Schedule A, are deleted.
23. Section 21 of the Agreement shall be deleted and replaced in its entirety
with the following:
21. SURVIVAL. The obligations of the parties contained in Sections 3.1,
3.2, 3.3, 3.9, 3.11, 3.14, 3.16, 3.17, 3.18, 3.19, 4.4, 4.5, 4.6, 4.7, 4.8, 5.6,
5.7, 6.6, 6.7, 8, 10, 12, 13, 16, 17, 18 and 20 shall survive the termination of
this Agreement.
24. Exhibits A, B, C and D to the Agreement shall be deleted and replaced in
their entirety with the Exhibits A, B, C and D attached to this Amendment.
25. Except as specifically set forth above, all other terms and conditions set
forth in the Agreement shall remain unchanged.
-23-
26. Capitalized terms not otherwise defined herein shall have the meaning
ascribed to them in the Agreement.
IN WITNESS WHEREOF the parties hereto have executed this Amendment as of
the date first above written.
GENSIA SICOR PHARMACEUTICALS, INC. XXXXXX PHARMACEUTICAL
PRODUCTS INC.
By: /s/ Xxxxxxx X. Xxxxxx By: /s/ Xxxxxx X. Xxxxxxx
------------------------------- ---------------------------------
Name: Xxxxxxx X. Xxxxxx Name: Xxxxxx X. Xxxxxxx
----------------------------- -------------------------------
Title: President & CEO Title: General Manager
---------------------------- ------------------------------
-24-
EXHIBIT A
-----------------------------------------------------------------------------------
PRODUCT FILL/VIAL SIZE CATALOGUE #
-----------------------------------------------------------------------------------
-----------------------------------------------------------------------------------
Atropine 0.4mg/mL 1 mL/2 mL 2501-0401
-----------------------------------------------------------------------------------
Atropine 0.4mg/mL 20 mL 2525-0301
-----------------------------------------------------------------------------------
Atropine 1.0 mg/mL 1 mL/2 mL 2511-0401
-----------------------------------------------------------------------------------
Atracurium besylate inj. 10 mg/mL 5 mL 2643-03
-----------------------------------------------------------------------------------
Atracurium besylate inj. 10 mg/mL 10 mL 2644-03
-----------------------------------------------------------------------------------
Bumetanide 0.25 mg/mL 2 mL 5062-0301
-----------------------------------------------------------------------------------
Bumetanide 0.25 mg/mL 4 mL/15 mL 5063-0301
-----------------------------------------------------------------------------------
Bumetanide 0.25 mg/mL 10 mL 6064-0301
-----------------------------------------------------------------------------------
Diltiazem 5 mg/mL 5 mL 1553-03
-----------------------------------------------------------------------------------
Diltiazem 5 mg/mL 10 mL 1554-03
-----------------------------------------------------------------------------------
Hetastarch 6% in 0.9% NaCl 500 mL 12 pack 5079-07
-----------------------------------------------------------------------------------
Metoclopramide 2 mL 4502-0401
-----------------------------------------------------------------------------------
Neostigmine 1 mg/mL 10 mL 2704-0302
-----------------------------------------------------------------------------------
Neostigmine 0.5 mg/mL 1 mL/2 mL 2711-0302
-----------------------------------------------------------------------------------
Neostigmine 0.5 mg/mL 10 mL 2714-0302
-----------------------------------------------------------------------------------
Pancuronium 1 mg/mL 10 mL 2804-0301
-----------------------------------------------------------------------------------
Pancuronium 2 mg/mL 2 mL 2812-0401
-----------------------------------------------------------------------------------
Pancuronium 2 mg/mL 5 mL 2823-0401
-----------------------------------------------------------------------------------
Propofol 20 mL 2856-0401
-----------------------------------------------------------------------------------
Propofol 50 mL 2858-0901
-----------------------------------------------------------------------------------
Propofol 100 m L 2859-0301
-----------------------------------------------------------------------------------
Propofol 20 mL syringe 2866-2301
-----------------------------------------------------------------------------------
Phenylephrine 2 mL 1631-0401
-----------------------------------------------------------------------------------
Sodium nitroprusside 2 mL 1802-0101
-----------------------------------------------------------------------------------
Thiopental 1 gm Kit 2530-0101
-----------------------------------------------------------------------------------
Thiopental 2.5 gm Kit 2540-0101
-----------------------------------------------------------------------------------
Thiopental 5.0 gm Kit 2550-0101
-----------------------------------------------------------------------------------
Thiopental 500 mg Syringe kit 2580-0101
-----------------------------------------------------------------------------------
Vecuronium 10 mg 10 mL 2914-0301
-----------------------------------------------------------------------------------
Vecuronium 20 mg 20 mL 2925-0301
-----------------------------------------------------------------------------------
-25-
EXHIBIT B
FINAL PRODUCT SPECIFICATIONS AND DATA SHEETS FOR HETASTARCH, VECURONIUM,
DILTIAZEM AND PROPOFOL WILL BE PROVIDED BY GENSIA SICOR TO XXXXXX PPI WITHIN TEN
(10) BUSINESS DAYS AFTER EXECUTION OF THE FOURTH AMENDMENT TO THE MANUFACTURING
AND DISTRIBUTION AGREEMENT.
-26-
EXHIBIT C
***
----------
*** Three pages of confidential material redacted and separately filed with
the Commission.
-27-
EXHIBIT D
Gensia Sicor Approved ANDAs and "Grandfathered" Products
----------------------------------------------------------------------------
AADA/ANDA NUMBER PRODUCT
----------------------------------------------------------------------------
---- GF Atropine Sulfate Injection, USP
----------------------------------------------------------------------------
ANDA 74-613 Bumetanide
----------------------------------------------------------------------------
ANDA 74-894 Diltiazem
----------------------------------------------------------------------------
ANDA 74-592 Hetastarch
----------------------------------------------------------------------------
ANDA 73-135 Metocloramide Injection, USP
----------------------------------------------------------------------------
---- GF Neostigmine Methylsulfate Injection, USP
----------------------------------------------------------------------------
ANDA 72-759 Pancuronium Bromide Injection
----------------------------------------------------------------------------
ANDA 72-760 Pancuronium Bromide Injection
----------------------------------------------------------------------------
---- GF Phenylephrine Hydrochloride Injection,
USP 1%
----------------------------------------------------------------------------
ANDA 75-102 Propofol
----------------------------------------------------------------------------
ANDA 73-465 Sodium Nitroprusside Injection
----------------------------------------------------------------------------
---- GF Thiopental Sodium for Injection
----------------------------------------------------------------------------
ANDA 74-688 Vecuronium
----------------------------------------------------------------------------
-28-
AMENDMENT TO MANUFACTURING & DISTRIBUTION AGREEMENT
THIS FIFTH AMENDMENT (the "Amendment"), dated as of November 8, 1999,
amends that certain Manufacturing & Distribution Agreement by and between GENSIA
SICOR PHARMACEUTICALS, INC. ("Gensia Sicor") (formerly Gensia Laboratories,
Ltd.) and XXXXXX PHARMACEUTICAL PRODUCTS INC. ("Baxter PPI") (formerly Ohmeda
Pharmaceutical Products Division Inc.) dated as of February 27, 1996, as amended
(the "Agreement").
1. Section 1.6 of the Agreement shall be amended to add the following new
Section 1.6.2 immediately following the end thereof:
1.6.2 Notwithstanding the foregoing, Gross Margin shall mean, with respect
to each Enalaprilat presentation or for each period, the positive remainder (if
any) of (a) the aggregate Net Sales of such Enalaprilat presentation during such
period, less (b) the applicable Transfer Price set forth in Exhibit C for such
Enalaprilat presentation, as adjusted pursuant to Section 5.3.2(b), multiplied
by the number of units thereof sold during such period.
2. Section 2.4 of the Agreement shall be amended to add the following new
Section 2.4.1 immediately following the end thereof:
2.4.1 ENALAPRILAT DEMAND SCHEDULE. Notwithstanding the foregoing, Baxter
PPI shall provide forecasts and orders for Enalaprilat as follows:
(a) Commencing on January 1, 2000, in each Demand Schedule provided
hereunder, Baxter PPI shall provide Gensia Sicor with a good faith twelve (12)
month forecast of its requirements for each presentation of Enalaprilat. The
first three (3) months forecasted requirements for Enalaprilat in each of the
Demand Schedules shall constitute firm purchase orders. Commencing with the next
Demand Schedule and in all subsequent Demand Schedules, the first two (2) months
forecasted requirements for
-1-
Enalaprilat in each Demand Schedule shall reflect Baxter PPI's firm purchase
orders communicated in previous Demand Schedules. Such Demand Schedule shall be
accompanied by a firm purchase order for the next succeeding (third) month
forecasted requirements for Enalaprilat.
(b) Baxter PPI shall be obligated to purchase ***of each firm
purchase order. Baxter PPI shall be obligated to purchase not less than the
following percentages of each Enalaprilat presentation forecasted for the
following months in the Demand Schedule provided by Baxter PPI to Gensia Sicor
for the first month of any calendar quarter during the term of this Agreement:
***
(c) Gensia Sicor shall not be obligated to supply more than *** of
the aggregate units of each Enalaprilat presentation forecasted for any month
(a) for each of months 4 -12 of the Demand Schedule required to be provided by
Baxter PPI to Gensia Sicor, and (b) for the twelfth (12th) month of each Demand
Schedule provided thereafter. Gensia Sicor will use commercially reasonable
efforts to supply sufficient quantities of Products above such amounts to
accommodate changing demand patterns in the market place.
3. Sections 2.8 of the Agreement shall be amended to add the following new
Section 2.8.2 immediately following the end thereof:
2.8.2 ENALAPRILAT AND THE TRANSITION PERIOD. The provisions of Section 2.8
shall not apply to Enalaprilat.
4. Sections 2.10 of the Agreement shall be amended to add the following new
Section 2.10.5 immediately following the end thereof:
--------
*** Confidential material redacted and separately filed with the Commission.
-2-
2.10.5 ENALAPRILAT. Baxter PPI agrees to purchase Gensia Sicor's finished
dosage Enalaprilat sufficient to meet *** of its requirements for Enalaprilat in
the Territory.
5. Sections 2.12.1 of the Agreement shall be deleted and replaced in its
entirety by the following:
2.12.1 OPTION TO DISCONTINUE PRODUCT. Notwithstanding the foregoing, if
the Transfer Price set forth on Exhibit C hereto for any presentation of
diltiazem, the Full Standard Cost for any presentation of vecuronium, the Landed
Cost for any presentation of hetastarch, or *** for any presentation of
Enalaprilat or Propofol *** of the *** (if any) for such Product presentation
set forth on Exhibit C hereto, then subject to the immediately following
sentence, Gensia Sicor shall have the right (at its option, in its sole
discretion) to terminate this Agreement as to such Product presentation on
ninety (90) days prior written notice to Baxter PPI. If Gensia Sicor elects to
terminate this Agreement as to any such Product presentation, then Baxter PPI
shall have the right, which may be exercised only by written notice to Gensia
Sicor within thirty (30) days after Baxter PPI's receipt of the termination
notice from Gensia Sicor, to continue this Agreement as to such Product
presentation for a period (the "Continuation Period") of up to one (1) year
after the date of Gensia Sicor's receipt of the continuation notice from Baxter;
provided, however, that (a) during the Continuation Period with respect to any
such Product presentation, Gensia Sicor shall not be obligated to deliver to
Baxter PPI more than the quantity of such Product presentation ordered in good
faith by Baxter PPI as necessary to satisfy its requirements under those
contracts of Baxter PPI existing and in effect as of the date of Baxter PPI's
receipt of the termination notice under this Section 2.12.1; and (b) if such
termination is with respect to all Propofol presentations, the technology
licenses granted under Section 2.13.1 shall terminate.
--------
*** Confidential material redacted and separately filed with the Commission.
-3-
6. Section 5.1 of the Agreement shall be deleted and replaced in its entirety
by the following:
5.1 TRANSFER PRICE. The price for each Product presentation
("Transfer Price"), other than Vecuronium, Hetastarch, Propofol and Enalaprilat,
to be delivered to Baxter PPI By Gensia Sicor during the term of this Agreement
shall be the sum of the applicable Per Unit Materials Cost for each Product
presentation and the applicable Variable Standard Cost; provided such sum does
not ***of , the *** on the Premier Purchasing Partners Contract as set forth in
Exhibit C hereto; provided the Transfer Price for Diltiazem 5mL and 10mL shall
not be *** respectively except as set forth in section 5.2. For Vecuronium the
Transfer Price shall be the Full Standard Cost for each presentation; provided
such sum does not *** of the *** on the Premier Purchasing Partners Contract as
set forth in Exhibit C hereto. For Enalaprilat the Transfer Price shall be the
*** for each presentation multiplied by ***; provided such sum does not *** of
*** on the Premier Purchasing Partners Contract as set forth in Exhibit C
hereto. Baxter PPI shall pay to Gensia Sicor an amount equal to the quantities
of each Product presentation delivered to Baxter PPI multiplied by the
applicable Transfer Price for such Product presentation. The terms of payment
are net thirty (30) days from the date of invoice which invoice shall not
predate the shipment of Products.
7. Section 5.1 of the Agreement shall be amended to add the following new
Section 5.1.2 immediately following the end thereof:
5.1.2 ENALAPRILAT INVOICE PRICE. Notwithstanding the foregoing,
Baxter PPI shall pay to Gensia Sicor an amount equal to the unit quantity of a
specific Enalaprilat presentation delivered to Baxter PPI by Gensia Sicor
multiplied by the applicable price (the "Enalaprilat Invoice Price") for such
presentation. The initial Enalaprilat Invoice Price payable by Baxter PPI to
Gensia Sicor is set forth in the following table:
--------
*** Confidential material redacted and separately filed with the Commission.
-4-
***
The initial Enalaprilat Invoice Price shall be in effect through the first two
calendar quarters after commercial launch. The terms of payment are net thirty
(30) days from the date of the invoice which invoice shall not predate the
shipment of Enalaprilat.
8. Section 5.2 of the Agreement shall be deleted and replaced in its entirety
by the following:
5.2 ADJUSTMENTS TO TRANSFER PRICE. Except as otherwise noted, set
forth on Exhibit C is a calculation by Gensia Sicor of the Per Unit Materials
Cost for each Product presentation based on actual invoices or purchase orders
in effect for such Materials at the time of the execution of this Amendment, the
Variable Standard Costs and the Full Standard Costs (for Vecuronium and
Enalaprilat), together with the resulting Transfer Price based on the
calculation in Section 5.1 hereof. The Per Unit Materials Cost, the Variable
Standard Costs, and the Full Standard Costs shall be adjusted at the beginning
of each Annual Period during the term of the Agreement. A Per Unit Materials
Cost reduction in the Diltiazem 5mL and 10mL product shall be reflected as a
reduction in the Transfer Price set forth in Section 5.1. Gensia Sicor shall
provide written notice of such adjustment thirty (30) days prior to the date of
the adjustment. Such adjustment will be based on the then current actual invoice
costs of Materials used to manufacture and package products to be delivered to
Baxter PPI, the actual Variable Standard Costs and the actual Full Standard
Costs during the applicable period.
9. Section 5.2.1 of the Agreement shall be deleted and replaced in its
entirety by the following:
5.2.1 ADJUSTMENTS TO PROPOFOL AND ENALAPRILAT INVOICE PRICE.
Notwithstanding the foregoing, not less than thirty (30) days prior to October
1, 1999 for Propfol, and not less that thirty (30) days prior to the end of the
second calendar quarter
--------
*** Confidential material redacted and separately filed with the Commission.
-5-
after launch for Enalaprilat, and not less than thirty (30) days prior to the
end of each calendar quarter thereafter during the term of this Agreement for
Propofol and Enalaprilat, the parties shall set a new Propofol and Enalaprilat
Invoice Price as follows:
(a) Following the expiration of the initial Propofol or Enalaprilat
Invoice Price, the Propofol or Enalaprilat Invoice Price payable by Baxter PPl
to Gensia Sicor for any presentation of Propofol or Enalaprilat delivered to
Baxter PPI by Gensia Sicor shall be calculated by adding the applicable Propofol
or Enalaprilat Transfer Price as set forth in Exhibit C hereto (for Propofol as
adjusted pursuant to Section 5.3.1(c) and for Enalaprilat as adjusted pursuant
to Section 5.3.2(b)) ***of Gensia Sicor's share of the *** which the parties
reasonably estimate will be earned on sales of such presentation during the
subsequent calendar quarter.
(b) If the parties are unable to timely reach mutually acceptable
agreement under Section 5.2.1(a) above on the applicable Propofol or Enalaprilat
Invoice Price for any Propofol or Enalaprilat presentation for any calendar
quarter, then the applicable Propofol or Enalaprilat Invoice Price for such
Propofol or Enalaprilat presentation for such calendar quarter shall be
calculated by adding the applicable Propofol or Enalaprilat Transfer Price as
set forth in Exhibit C hereto (as adjusted pursuant to Section 5.3.1 (c) or
Section 5.3.2(b) below) to *** of Gensia Sicor's share of the *** (calculated
based upon the *** of all sales of such Propofol or Enalaprilat presentation
during the preceding twelve (12) full calendar months to the *** of such
Propofol and/or Enalaprilat presentation during such twelve (12) full calendar
month period).
10. Section 5.3 of the Agreement shall be amended to add the following new
Section 5.3.2 immediately following the end thereof:
--------
*** Confidential material redacted and separately filed with the Commission.
-6-
5.3.2 ENALAPRILAT PERCENTAGE PAYMENT.
(a) Notwithstanding the foregoing, the total amount payable by
Baxter PPI to Gensia Sicor shall be the Transfer Price as set forth in Exhibit C
(as adjusted pursuant to Section 5.3.2(b) below) and a Percentage Payment ***of
the *** on Enalaprilat delivered by Gensia Sicor and sold by Baxter PPI and its
Affiliates in the Territory. Baxter PPI will provide payment to Gensia Sicor on
a quarterly basis not more than sixty (60) days following the end of each
quarter during the term of this Agreement.
(b) Each payment shall be accompanied by a statement detailing the
Net Sales of Enalaprilat for the applicable quarter by product presentation, the
calculation of the Percentage Payment earned as set forth herein, and a
reconciliation calculation detailing the total amount received by Gensia Sicor
and the Percentage Payment amount earned by Gensia Sicor during the applicable
period.
(c) In addition, at meetings between inventory personnel of the .
respective parties (which shall not be less than quarterly), Baxter PPI shall
report to Gensia Sicor the inventory on hand, by product presentation.
(d) For purposes of calculating the Percentage Payment for each
enalaprilat presentation, the Transfer Price for such enalaprilat presentation
shall be adjusted commencing with the beginning of each calendar year after
Baxter PPI's commercial launch of enalaprilat to equal *** of Gensia Sicor's ***
for such enalaprilat presentation for such calendar year;
provided that, if such Transfer Price *** of the *** therefor on the then
current Premier Purchasing Partners Contract as set forth in Exhibit C hereto,
the Transfer Price shall be adjusted to *** of Gensia Sicor's ***. In no event
shall Gensia Sicor be compelled to sell enalaprilat to Baxter at a Transfer
Price less than Gensia Sicor's Full Standard Cost. Notwithstanding the
foregoing, in the event the Transfer Price for any enalaprilat
--------
*** Confidential material redacted and separately filed with the Commission.
-7-
presentation ***of the *** therefor on the then current Premier Purchasing
Partners Contract, Baxter shall have the right to delete such presentation from
this Agreement on ninety (90) days written notice to Gensia Sicor.
11. Exhibits A, B, C and D to the Agreement shall be deleted and replaced in
their entirety with the Exhibits A, B, C and D attached to this Amendment.
12. Except as specifically set forth above, all other terms and conditions set
forth in the Agreement shall remain unchanged.
13. Capitalized terms not otherwise defined herein shall have the meaning
ascribed to them in the Agreement.
IN WITNESS WHEREOF the parties hereto have executed this Amendment as of
the date first above written.
GENSIA SICOR PHARMACEUTICALS, INC. XXXXXX PHARMACEUTICAL |
PRODUCTS INC.
By: /s/ Xxxxx X. Xxxxxx By: /s/ Xxxxxx Xxxxxxx
-------------------------------- -----------------------------------
Name: Xxxxx X. Xxxxxx Name: Xxxxxx Xxxxxxx
------------------------------ ----------------------------------
Title: President Title: General Manager
---------------------------- ---------------------------------
--------
*** Confidential material redacted and separately filed with the Commission.
-8-
EXHIBIT A
---------------------------------------------- ------------------------------- -----------------------------
PRODUCT FULL/VIAL SIZE CATALOGUE #
---------------------------------------------- ------------------------------- -----------------------------
---------------------------------------------- ------------------------------- -----------------------------
Atropine 0.4mg/mL 1 mL/2 mL 2501-0401
---------------------------------------------- ------------------------------- -----------------------------
Atropine 0.4mg/mL 20 mL 2525-0301
---------------------------------------------- ------------------------------- -----------------------------
Atropine 1.0 mg/mL 1 mL/2 mL 2511-0401
---------------------------------------------- ------------------------------- -----------------------------
Atracurium besylate inj. 10 mg/mL 5 mL 2643-03
---------------------------------------------- ------------------------------- -----------------------------
Atracurium besylate inj. 10 mg/mL 10 mL 2644-03
---------------------------------------------- ------------------------------- -----------------------------
Bumetanide 0.25 mg/mL 2 mL 5062-0301
---------------------------------------------- ------------------------------- -----------------------------
Bumetanide 0.25 mg/mL 4 mL/5 mL 5063-0301
---------------------------------------------- ------------------------------- -----------------------------
Bumetanide 0.25 mg/mL 10 mL 6064-0301
---------------------------------------------- ------------------------------- -----------------------------
Diltiazem 5 mg/mL 5 mL 1553-03
---------------------------------------------- ------------------------------- -----------------------------
Diltiazem 5 mg/mL 10 mL 1554-03
---------------------------------------------- ------------------------------- -----------------------------
Enalaprilat 1.25mg/mL 1mL 1mL in 2mL Vial 8401-01
---------------------------------------------- ------------------------------- -----------------------------
Enalaprilat 1.25mg/mL 2mL 2mL in 2mL Vial 8411-01
---------------------------------------------- ------------------------------- -----------------------------
Hetastarch 6% in 0.9% NaCl 500 mL 12 pack 5079-07
---------------------------------------------- ------------------------------- -----------------------------
Metoclopramide 2 mL 4502-0401
---------------------------------------------- ------------------------------- -----------------------------
Neostigmine 1 mg/mL 10 mL 2704-0302
---------------------------------------------- ------------------------------- -----------------------------
Neostigmine 0.5 mg/mL 1 mL/2 mL 2711-0302
---------------------------------------------- ------------------------------- -----------------------------
Neostigmine 0.5 mg/mL 10 mL 2714-0302
---------------------------------------------- ------------------------------- -----------------------------
Pancuronium 1 mg/mL 10 mL 2804-0301
---------------------------------------------- ------------------------------- -----------------------------
Pancuronium 2 mg/mL 2 mL 2812-0401
---------------------------------------------- ------------------------------- -----------------------------
Pancuronium 2 mg/mL 5 mL 2823-0401
---------------------------------------------- ------------------------------- -----------------------------
-9-
---------------------------------------------- ------------------------------- -----------------------------
Propofol 20 mL 2856-0401
---------------------------------------------- ------------------------------- -----------------------------
Propofol 50mL 2858-0901
---------------------------------------------- ------------------------------- -----------------------------
Propofol 100mL 2859-0301
---------------------------------------------- ------------------------------- -----------------------------
Propofol 20 mL syringe 2866-2301
---------------------------------------------- ------------------------------- -----------------------------
Phenylephrine 2 mL 1631-0401
---------------------------------------------- ------------------------------- -----------------------------
Sodium nitroprusside 2 mL 1802-0101
---------------------------------------------- ------------------------------- -----------------------------
Thiopental 1 gm Kit 2530-0101
---------------------------------------------- ------------------------------- -----------------------------
Thiopental 2.5 gm Kit 2540-0101
---------------------------------------------- ------------------------------- -----------------------------
Thiopental 5.0 gm Kit 2550-0101
---------------------------------------------- ------------------------------- -----------------------------
Thiopental 500 mg Syringe kit 2580-0101
---------------------------------------------- ------------------------------- -----------------------------
Vecuronium 10 mg 10 mL 2914-0301
---------------------------------------------- ------------------------------- -----------------------------
Vecuronium 20 mg 20 mL 2925-0301
---------------------------------------------- ------------------------------- -----------------------------
-10-
EXHIBIT B
FINAL PRODUCT SPECIFICATIONS AND DATA SHEETS FOR ENALAPRILAT WILL BE PROVIDED BY
GENSIA SICOR TO BAXTER PP I NO LATER THAN TEN (10) BUSINESS DAYS PRIOR TO THE
DATE OF SHIPMENT OF THE FIRST COMMERCIAL BATCHES FROM GENSIA SICOR TO BAXTER
PPI.
-11-
EXHIBIT C
***
----------
*** Three pages of confidential material redacted and separately filed with
the Commission.
-12-
EXHIBIT D
Gensia Sicor Approved ANDAs and "Grandfathered" Products
-----------------------------------------------------------------------------
AADA/ANDA NUMBER PRODUCT
-----------------------------------------------------------------------------
-- GF Atropine Sulfate Injection, USP
-----------------------------------------------------------------------------
ANDA 74-613 Bumetanide
-----------------------------------------------------------------------------
ANDA 74-894 Diltiazem
-----------------------------------------------------------------------------
ANDA 75-578 Enalaprilat
-----------------------------------------------------------------------------
ANDA 74-592 Hetastarch
-----------------------------------------------------------------------------
ANDA 73-135 Metoclopramide Injection, USP
-----------------------------------------------------------------------------
-- GF Neostigmine Methylsulfate Injection, USP
-----------------------------------------------------------------------------
ANDA 72-759 Pancuronium Bromide Injection
-----------------------------------------------------------------------------
ANDA 72-760 Pancuronium Bromide Injection
-----------------------------------------------------------------------------
-- GF Phenylephrine Hydrochloride Injection,
USP 1%
-----------------------------------------------------------------------------
ANDA 75-102 Propofol
-----------------------------------------------------------------------------
ANDA 73-465 Sodium Nitroprusside Injection
-----------------------------------------------------------------------------
-- GF Thiopental Sodium for Injection
-----------------------------------------------------------------------------
ANDA 74-688 Vecuronium
-----------------------------------------------------------------------------
-13-
[SIXTH] AMENDMENT TO MANUFACTURING & DISTRIBUTION AGREEMENT
THIS [SIXTH] AMENDMENT (the "Amendment"), dated as of July 11, 2001,
amends that certain Manufacturing & Distribution Agreement by and between GENSIA
SICOR PHARMACEUTICALS, INC. ("Gensia Sicor") (formerly Gensia Laboratories,
Ltd.) and XXXXXX PHARMACEUTICAL PRODUCTS INC. ("Baxter PPI") (formerly Ohmeda
Pharmaceutical Products Division Inc.) dated as of February 27, 1996, as amended
(the "Agreement").
1. Section 1.6.2 of the Agreement shall be amended by deleting the phrase "as
adjusted pursuant to Section 5.3.2(b),".
2. Section 5.1.2 of the Agreement is deleted.
3. Section 5.2.1 of the Agreement shall be amended by deleting the phrases
"and Enalaprilat", "or Enalaprilat" and "and/or Enalaprilat" wherever they occur
in such section; by deleting the phrase ", and not less than thirty (30) days
prior to the end of the second calendar quarter after launch for Enalaprilat" in
the third and fourth lines thereof; by deleting the phrase "and for Enalaprilat
as adjusted pursuant to Section 5.3.2(b)" in subsection 5.2.1(a) thereof; and by
deleting the phrase "or Section 5.2.2(b)" in subsection 5.2.1(b) thereof.
4. Except as specifically set forth above, all other terms and conditions set
forth in the Agreement shall remain unchanged.
5. Capitalized terms not otherwise defined herein shall have the meaning
ascribed to them in the Agreement.
-1-
IN WITNESS WHEREOF the parties hereto have executed this Amendment as of
the date first above written.
GENSIA SICOR PHARMACEUTICALS, INC. XXXXXX PHARMACEUTICAL PRODUCTS INC.
By: /s/ Xxxxx X. Xxxxxx By: /s/ Xxxxxx X. Xxxxxxx
---------------------------- ------------------------------
Name: Xxxxx X. Xxxxxx Name: Xxxxxx X. Xxxxxxx
--------------------------- -----------------------------
Title: COO and President Title: VP and General Manager
------------------------- ---------------------------
-2-
