EXHIBIT 10.2
SUPPLY AGREEMENT
This Supply Agreement, dated as of the 1st day of January 2001 (the
"Effective Date"), is between Novartis Consumer Health, Inc., 000 Xxxxxx Xxxxxx,
Xxxxxx, Xxx Xxxxxx 00000 ("Novartis"), and CIMA LABS INC., 00000 Xxxxxx Xxxx
Xxxx, Xxxx Xxxxxxx, XX 00000 ("Supplier").
WHEREAS Supplier and Novartis are parties to a License Agreement dated
July 1, 1998 (the "License Agreement") and a Supply Agreement dated July 1, 1998
and an Amendment No. 1 thereto dated as of November 19, 1999 (collectively, the
"Prior Supply Agreement"); and
WHEREAS Supplier and Novartis wish to enter into a new Supply Agreement to
supersede the Prior Supply Agreement;
IT IS THEREFORE AGREED by and between the parties hereto as follows:
1. GENERAL SCOPE OF AGREEMENT
1.1 This Agreement shall supersede the Prior Supply Agreement as of the
Effective Date. The Prior Supply Agreement is hereby terminated without penalty
to either party, and shall be of no further force or effect after the Effective
Date. Notwithstanding the foregoing, the License Agreement remains in full force
and effect. Nothing set forth herein shall be deemed to effect any modification
to the terms of the License Agreement, except that (i) any references to the
"Supply Agreement" contained in the License Agreement shall be deemed to be
references to this Agreement; and (ii) any references in the License Agreement
to specific provisions of the "Supply Agreement" shall be deemed to be
references to the provisions set forth in this Agreement which are equivalent to
the Sections of the Prior Supply Agreement referred to in the License Agreement
(in particular, references in the License Agreement to provisions contained
within Section 12 of the Prior Supply Agreement shall be deemed to be references
to the equivalent provisions set forth within Section 7 of this Agreement).
1.2 Supplier shall manufacture, sell and cause to be delivered
exclusively to Novartis the products set forth in Exhibit A hereto (the
"Products") in accordance with and subject to the terms and conditions of this
Agreement, in quantities sufficient to meet the total requirements, consistent
with the forecasting and purchase order mechanism set forth in Article 3 of this
Agreement, of Novartis for such Products for use in the Territory (as defined in
the License Agreement).
1.3 Novartis shall purchase all of Novartis' requirements of the
Products for use in the Territory exclusively from Supplier, in accordance with
and subject to the terms and conditions of this Agreement. This requirements
obligation is limited to Novartis' requirements of Products which meet the
Specifications (as defined below).
1.4 Novartis shall be responsible for obtaining regulatory approval of
any products sold by Novartis. Supplier shall cooperate with Novartis and shall
use its commercially reasonable best efforts to assist Novartis in obtaining any
and all regulatory approvals necessary to market Novartis' products which
contain the Products.
1.5 All Products sold and delivered to Novartis hereunder shall (a) be
manufactured, packaged and sold in strict accordance with (i) the Quality
Assurance Agreement, attached hereto as Exhibit B (the "QA Agreement"),
including the specifications set forth therein, and with such further
specifications as shall be agreed to by Supplier and Novartis in writing (the
"Specifications"); and (ii) all applicable laws, regulations, and requirements
of any government or governmental agency; and (b) be subject to the warranties
set forth in Article 9 of this Agreement.
1.6 In order for the parties to conduct long-term planning with respect
to the manufacture and sales of the Products, senior representatives of Supplier
and Novartis shall meet annually, on or about the anniversary of the Effective
Date, and shall each present to the other the current status of its business and
its long-term plans with respect to the Products.
2. PAYMENT
2.1 In consideration of the satisfactory manufacture and delivery to
Novartis of the ordered quantities of Products, Novartis shall pay Supplier for
all Products accepted by Novartis pursuant to Section 4.1 of this Agreement in
accordance with the prices set forth in Exhibit C hereto, subject to adjustment
in accordance with this Agreement. Novartis shall make such payments within
thirty (30) days of the date of Supplier's invoice. Supplier shall issue its
invoice to Novartis upon the delivery of Products to Novartis hereunder.
2.2 Novartis shall bear the cost of any taxes of any kind, nature or
description whatsoever applicable to the sale of any Products by Supplier to
Novartis (except for any taxes based upon the income of Supplier or its
employees), unless Novartis is exempt from such taxes and provides to Supplier,
at the time of the submission of any purchase order, tax exemption certificates
or permits acceptable to the appropriate taxing authorities.
2.3 Shipping terms for the Products are EXW (Incoterms 2000), place of
manufacture. Notwithstanding the foregoing, Supplier shall load all Product onto
the trucks of Novartis' designated carrier, and title to and risk of loss of the
Products shall pass to Novartis when the Product is so loaded.
2.4 On [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***], the price at which
Novartis shall purchase the Products shall be increased or decreased to pass on
to Novartis, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] of any net increase
or decrease in the cost of (i) the raw materials and packaging materials
necessary to the manufacture of Products (collectively, the "Raw Materials");
and (ii) direct labor and fully-absorbed overhead rates (collectively, the
"Overhead") actually incurred by Supplier in
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producing the Products during the twelve (12) month period ending on the
preceding December 31. Such increase or decrease shall be effective with respect
to Product delivered to Novartis after the [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]
effective date of the applicable price adjustment.
2.4.1 On or before [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***],
Supplier shall provide Novartis with a non-binding estimate of the amount by
which the price will increase or decrease pursuant to this Section 2.4
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***]. Supplier shall determine the final
amount of any such increase or decrease by no later than the following
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***], and Supplier shall notify Novartis of
such amount in writing at that time. Product delivered to Novartis between
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***] shall be invoiced to Novartis at the
price applicable to Product delivered to Novartis during the immediately
preceding calendar year. Then on or about [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***], Supplier shall transmit to Novartis a corrected invoice for
Product delivered between [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***], taking into
account the final amount of any such price increase or decrease, and setting
forth the applicable additional charges or credits.
2.4.2 To determine the amount by which the cost of Raw Materials and
Overhead have increased or decreased during a period, the Raw Material and
Overhead costs at the beginning of the period shall be compared to the Raw
Material and Overhead costs at the end of the period, without regard to
intervening fluctuations. Notwithstanding the foregoing, in the event that (i)
the parties shall agree upon Supplier undertaking the development work necessary
to support the substitution of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] coated
in Supplier's own facilities (in Products containing [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***]) for coated [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] purchased from
third parties, and (ii) such development work is successfully completed, then in
calculating the amount by which the cost of Raw Materials has increased or
decreased during a period, Supplier shall only pass on to Novartis
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***] of any cost savings associated with the
substitution of Supplier-coated [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***].
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2.4.3 In no event shall any increase or decrease in price pursuant
to Section 2.4(ii) exceed, on a percentage basis, the percentage which the
Producers' Price Index, published by the U.S. Department of Labor, Bureau of
Labor Statistics, increased during the period since the last increase under
Section 2.4(ii).
2.4.4 At Novartis' request, the parties shall informally discuss the
factors which contributed to any price adjustment hereunder.
2.5 If, for any reason other than a Force Majeure Event (as defined in
Section 6.7), Supplier fails to deliver Products ordered in accordance with the
lead-times set forth in Section 3.2, in the quantities so ordered, within twenty
(20) days of the date specified in the applicable purchase order, then Novartis
shall be entitled, as liquidated damages, and not a penalty, to a discount of
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***] off the price of the late-delivered
Products.
2.6 Novartis shall have the right, not more than once in each calendar
year, upon reasonable notice and during normal business hours, to review through
an independent certified public accounting firm selected jointly by the parties,
but retained by Novartis (the "CPA Firm"), such records of Supplier as may be
necessary to verify the accuracy of the amounts invoiced to Novartis hereunder,
including the accuracy of any price adjustments made hereunder. The prices
charged for the Products shall be increased or decreased in accordance with the
CPA Firm's conclusions, including through the crediting of Novartis' account for
any overcharges, and through the payment by Novartis of any additional amounts
for any undercharges, actually incurred in the period audited.
2.6.1 Novartis shall pay all fees of the CPA Firm performing such
verification unless the CPA Firm concludes that there has been any cumulative
overcharge of prices of more than [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] in the
period audited, in which case Supplier shall bear all reasonable costs of the
audit charged by the CPA Firm.
2.6.2 Novartis shall instruct the CPA Firm not to disclose to
Novartis any information other than its conclusion as to the the accuracy of the
amounts invoiced to Novartis hereunder, including the accuracy of any price
adjustments made hereunder, and the amount of any variance between the amounts
actually invoiced to Novartis and the amounts which the CPA Firm determines
should have been invoiced.
2.6.3 In the event that Supplier should disagree with the
conclusions of the CPA Firm, it shall have the right to provide the CPA Firm
with any additional information it so chooses, and to request the CPA Firm to
reconsider. The CPA Firm shall review any such submissions and resolve the issue
in accordance with this Agreement and the facts. The costs charged by the CPA
Firm for conducting such a reconsideration shall be paid by the party against
whom the determination was made.
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2.7 Novartis may at any time identify to Supplier suppliers from which
Supplier might obtain any of the Raw Materials at a lower cost than Supplier is
able to obtain such Raw Materials. In such an event, the parties shall evaluate
the new suppliers' proposed pricing and determine whether such suppliers present
an opportunity for significant cost savings, and whether Supplier would incur
significant expenses in shifting to that supplier. Should the parties jointly
determine that it would be appropriate for Supplier to shift to any such new
suppliers, then Supplier shall utilize such suppliers, and the prices charged to
Novartis for Product hereunder shall be reduced as follows: (i) during the first
one (1) year from the date Supplier first utilizes supplies from any such new
supplier (the "Initial Year"), Supplier shall reduce the prices charged to
Novartis for Product by [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] of the amount
of any realized savings; and (ii) after the Initial Year, Supplier shall reduce
the prices charged to Novartis for Product by [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***] of the amount of any realized savings. Supplier shall not
unreasonably withhold its approval of any new suppliers identified by Novartis
hereunder. In making any such switch, Supplier shall be allowed to exhaust its
inventory of higher cost Raw Materials prior to commencing the use of the lower
cost materials from the new supplier. Novartis shall reimburse Supplier for any
costs Supplier shall reasonably incur in implementing any such change in
suppliers. Supplier shall maintain accurate records in sufficient detail to
clearly document any such cost savings which result from any new suppliers
identified by Novartis pursuant to this Section. Upon request, Supplier shall
provide all such records to Novartis.
2.8 Novartis and Supplier shall confer on a regular basis, but no less
than annually, to consider whether new technologies or new manufacturing methods
may exist which likely would reduce Supplier's cost of manufacturing the
Products. Should any such technologies and/or methods be identified, then
(unless utilizing such technologies and/or methods would restrict Supplier's
ability to conduct drug delivery projects for third parties) the parties shall
discuss the sharing of the costs of developing and implementing such
technologies and/or methods, and of the proceeds from any resulting cost
reductions in amounts to be agreed upon.
3. FORECASTS AND ORDERS
3.1 In order to assist Supplier in planning production, Novartis shall,
on or before the tenth (10th) day of each month, provide Supplier with a twelve
(12) month rolling forecast of the quantities of Products required by Novartis,
by month, for the following twelve (12) months. It is understood that such
forecasts are intended to be estimates only, and shall not be binding upon
Novartis. Notwithstanding the foregoing, Novartis shall be bound to purchase
from Supplier [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] of those quantities
of Products set forth in each such forecast as being Novartis' requirements of
Products for the first three (3) months of each twelve (12) month period.
Supplier shall, no later than fifteen (15) business days after receipt of each
such forecast, notify Novartis in writing of any prospective problems of which
it is aware that might prevent it from meeting Novartis'
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forecasted order quantities or estimated delivery dates. Unless Supplier so
informs Novartis that it would have problems in meeting Novartis' forecasted
requirements, Supplier shall be obligated to deliver during any calendar year,
pursuant to purchase orders provided under Section 3.2 of this Agreement, up to
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***] of Novartis' estimated purchases for that
calendar year. Supplier shall further use its commercially reasonable best
efforts to comply with orders for Products in excess of such [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION***] amount.
3.2 At least [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] prior to the date on
which Novartis desires to have Product delivered, Novartis shall furnish to
Supplier a binding purchase order for the quantity of Products which Novartis
shall purchase and Supplier shall deliver. The quantities to be delivered under
any such purchase order shall be in full batch-size quantities only, and for a
minimum of four (4) batches. Notwithstanding the foregoing, Novartis shall use
its commercially reasonable best efforts to consolidate its orders into at
quantities of eight (8) batches. Supplier shall, within five (5) business days
after its receipt of such purchase order, acknowledge such receipt and confirm
that the order can be supplied. Each such purchase order shall designate the
quantity of Products ordered and the date by which Supplier must deliver the
Products to Novartis.
3.3 Supplier shall use its commercially reasonable best efforts to
accommodate any Novartis requests for Product in excess of the quantities
described in any previously-submitted purchase order, or for delivery of Product
sooner than that allowed pursuant to this Article 3. Should Novartis' business
conditions necessitate reduction or delay in purchase order requirements, then
Supplier shall use its commercially reasonable best efforts to implement such
requested changes. Without limiting the generality of the foregoing, Novartis
shall have the right, up to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] prior
to the date of manufacture, to issue binding change orders, without charge, to
increase or decrease the quantities of Product ordered in any
previously-submitted purchase orders by amounts of up to [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION***] of the total quantity of Products ordered in such
purchase order. Notwithstanding anything to the contrary herein, (i) Supplier
shall not be obligated to accept any requests for modifications to purchase
orders during the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] period prior to the
date of manufacture; and (ii) Supplier shall not take any action in response to
any requests for modifications to purchase orders which would result in charges
to Novartis in addition to the standard purchase price permitted hereunder
without Novartis' prior written consent.
3.4 Supplier shall order each Raw Material in accordance with the
lead-time therefor specified in Exhibit D hereto, in amounts sufficient to
enable Supplier to manufacture [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED
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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] of those quantities
of Product forecast to be required at the end of the particular lead-time period
(as set forth in the most recent forecast issued pursuant to Section 3.1
available at the time which the order for the particular Raw Material must be
issued).
3.4.1 By way of example, if Raw Material A had a ninety (90) day
lead-time, and Raw Material B had a thirty (30) day lead-time, then in January,
Supplier shall order enough Raw Material A to meet [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***] of those quantities of Product forecast to be required in April,
and enough Raw Material B to meet [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] of
those quantities of Product forecast to be required in February, as set forth in
the most recent forecast available in January.
3.4.2 Should any Raw Materials obtained in accordance with the
requirements of this Section (or any additional quantities ordered as a result
of standard container sizes or minimum order quantities imposed by Supplier's
suppliers) become unusable due to changes in Product or purchase order
requirements, then Novartis shall reimburse Supplier for the full cost of such
unusable Raw Materials. Supplier shall use all reasonable commercial efforts to
mitigate any such losses of Raw Materials. Supplier shall submit supporting
documentation on all claims based on unusable Raw Materials, and requests for
reimbursement thereof.
3.5 If for any reason Supplier experiences any shortage of any input
used by Supplier in manufacturing the Products, including without limitation Raw
Materials, labor and plant capacity (each, an "Input"), and is therefore unable
to supply Novartis with the full quantity of Products ordered by it and accepted
by Supplier by the date set forth in the purchase order, then Novartis shall be
entitled to the same proportionate quantity of the Input as the quantity of the
Input used by Supplier in manufacturing Products for Novartis in the twelve (12)
months preceding the shortage bears to the total quantity of the Input used by
Supplier in manufacturing products for all its customers, during such period.
4. INSPECTIONS AND ACCEPTANCE
4.1 Novartis shall accept any delivery of Products hereunder if, in
Novartis' sole discretion, Novartis determines that the delivery complies fully
with the relevant purchase order, the Specifications, and with the requirements
of this Agreement. Novartis shall inspect all Products delivered hereunder, and
shall provide Supplier with written notice of its acceptance or rejection of the
delivery, as soon as reasonably practicable, but not later than thirty (30) days
after its receipt of the Products and all required documentation. Any notice of
rejection shall specify the reason(s) therefor. Except in the event of any
investigation, corrective action or retesting of a delivery, should Novartis
fail to provide Supplier with written notice of its acceptance or rejection of
the delivery within thirty (30) days of receipt of the Products and all required
documentation, then the delivery shall be deemed to have been accepted by
Novartis on the thirtieth (30th) day after delivery. After notice of rejection
is received by Supplier, Novartis shall cooperate with Supplier in determining
whether rejection is necessary or justified. Supplier
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shall notify Novartis as soon as reasonably possible, but not later than thirty
(30) days after receipt of the notice from Novartis, whether it accepts
Novartis' basis for rejection. If Supplier accepts Novartis' determination that
the Products are nonconforming, then Novartis shall be entitled to the remedies
set forth in Section 4.2. If Supplier does not accept Novartis' determination
that the Products are nonconforming, Novartis and Supplier jointly shall select
an independent third party expert to test the Products and determine whether
they conform to the applicable specifications. The parties agree that such third
party's determination shall be final. The party against whom the third party
rules shall bear the reasonable costs of the third party testing. If the third
party rules that the Product conforms to the specifications, Novartis shall
purchase the Products at the agreed upon price. If the third party rules that
the Product is nonconforming, then Novartis shall be entitled to the remedies
set forth in Section 4.2. Notwithstanding anything to the contrary herein, a
Product shall not be deemed nonconforming for purposes of this Agreement if such
nonconformance was caused by the acts or omissions of Novartis after delivery of
the Product in accordance with Section 2.3.
4.2 Once any such delivery, or any part thereof, is finally deemed to be
rejected, then, at Novartis' option, (a) Supplier shall, at no additional
charge, deliver replacement Products to Novartis as soon as reasonably
practicable thereafter (but, in any event, within sixty (60) days after the
initial notification by Novartis); or (b) the purchase order at issue shall be
deemed terminated, and Novartis shall not be obligated to make any payments to
Supplier with respect to such purchase order, or the rejected delivery (or, if
payment has already been made for such Products, then Novartis shall be entitled
to a credit in such an amount).
5. DOCUMENTATION AND INFORMATION
5.1 Supplier shall provide to Novartis all documentation and information
reasonably requested by Novartis (a) to assist Novartis in determining whether
any delivery complies fully with the Specifications and the requirements of this
Agreement; (b) to assist Novartis in obtaining any and all regulatory approvals
necessary to market Novartis' products which contain the Products; or (c) to
enable Novartis to comply with any statutory or regulatory requirements, or with
a request by any governmental or regulatory authority.
5.2 Every delivery of Products to Novartis shall be accompanied by a
Certificate of Analysis. Supplier hereby warrants the accuracy of each such
Certificate of Analysis to a reasonable degree of scientific certainty.
5.3 Upon request, Supplier shall submit to Novartis all manufacturing
and testing documents relating to any Products ordered hereunder, including
analyses with instrument conditions, within [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***] of the completion of the manufacturing process with respect to
any particular batch of Products.
6. PRODUCTION PROCEDURES
6.1 Supplier shall not rework or reprocess any non-conforming Products
without the prior written approval of Novartis. Notwithstanding the foregoing,
Supplier may correct minor
8
packaging defects observed prior to the completion of production of a batch of
Products without the prior written approval of Novartis. Supplier shall describe
any such corrections in the applicable batch records.
6.2 The Products shall be delivered to Novartis packaged in accordance
with the Specifications. Notwithstanding the foregoing, Novartis shall have the
right to require any special or varied packing that it believes is reasonably
necessary to meet customs or regulatory requirements. Reasonable incremental
costs which result directly from any packing changes required by Novartis will
be borne by Novartis.
6.3 At least [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] prior to its first
production run of Products, and prior to the production of qualification
batches, Supplier shall provide to Novartis written notice thereof. Supplier and
Novartis shall then agree upon a schedule for the review and approval by
Novartis of Supplier's production procedures for the Products, including without
limitation the manufacturing site, manufacturing equipment, manufacturing
process, manufacturing conditions or testing procedures within its facilities
for the manufacture of the Products (collectively, the "Production Procedures").
After such initial Novartis approval, if Supplier should wish to change any of
the Production Procedures, Supplier shall provide written notice of such
proposed changes to Novartis at least [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]
prior to implementation. Supplier and Novartis shall then agree upon a schedule
for the review and approval by Novartis of such changes, which must be approved
in writing by Novartis prior to being implemented, which approval shall not
unreasonably be withheld.
6.4 In the event that regulatory action or applicable law require
changes in the Specifications or any production procedures, then, subject to
Novartis' prior written agreement, Supplier shall use its commercially
reasonable best efforts to implement such changes as soon as reasonably
practicable. Should such regulatory action or applicable law only require
changes to the Products and not to any other products manufactured by Supplier,
then Novartis shall pay the reasonable costs actually incurred by Supplier in
implementing such changes. In all other events, the parties shall enter into
good faith negotiations to allocate the costs of any such changes between them.
6.5 Supplier represents and warrants, and shall take all actions
reasonably necessary to ensure, that all facilities, equipment and practices
used to perform its responsibilities under this Agreement by or on behalf of
Supplier, or any of Supplier's environmental or safety and health consultants or
waste management or disposal contractors (collectively, the "Supplier
Contractors"), will be during the term of this Agreement, in full compliance
with all health, safety and environmental laws, statutes, ordinances,
regulations, rules, permits and pronouncements.
6.5.1 Supplier assumes responsibility for disposing of any and all
waste generated during the performance of its responsibilities under this
Agreement (including, without
9
limitation, during any manufacturing, storage and transportation activities) in
accordance with all legal and professional standards.
6.5.2 Notwithstanding anything to the contrary herein, (i) should
Supplier and/or any Supplier Contractor fail to comply with the obligations set
forth in this Section 6.5, then Supplier shall be solely responsible for any
claims, suits, or liabilities resulting therefrom (including, without
limitation, those based on strict liability and joint and several liability),
and Supplier shall indemnify, defend and save Novartis (including officers,
directors, employees and agents of Novartis) harmless from and against any and
all such claims, suits, and liabilities; and (ii) Supplier shall indemnify,
defend and save Novartis (including officers, directors, employees and agents of
Novartis) harmless from and against any and all claims, suits, and liabilities
which arise directly or indirectly from the storage, release, transportation or
disposal of chemicals, raw materials, product, waste or any other substance by
Supplier and/or any Supplier Contractor.
6.6 Packaging and labeling content for Products shall be determined by
Novartis in its sole discretion. A representative sample or proof of all
packaging materials and labels will be submitted to Novartis for approval prior
to initial use. If Novartis wishes to institute changes in artwork, both parties
will develop a mutually acceptable implementation schedule and such changes will
be at Novartis' expense. Supplier shall purchase labeling and packaging
components in accordance with Novartis artwork. Supplier shall not alter, change
or in any way modify Novartis supplied artwork for any reason, without prior
written consent from Novartis. Commencing on the date this Agreement is signed
by the last party to sign it, Novartis shall be entitled to change the artwork
on each SKU of Product one (1) time in each calendar year without charge.
Novartis shall pay Supplier [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] per SKU
for each additional artwork change. Notwithstanding the foregoing, Novartis
shall not be charged for any artwork changes which are instigated by Supplier.
6.7 Neither party shall be liable for any failure to deliver or receive,
or delay in delivery or receipt of, any shipment when such failure or delay
shall be caused (directly or indirectly) by fire; flood; accident; explosion;
sabotage; civil commotions; riots; invasions; wars (present or future); acts,
restraints, requisitions, regulations, or directions of any governmental
authority; compliance by a party with any request of any governmental authority,
or any officer, department, agency, or committee thereof; compliance by a party
with any request for material represented to be for purposes of (directly or
indirectly) producing articles for national defense or national defense
facilities; shortage of labor, fuel, power or raw materials; inability to obtain
supplies; failures of normal sources of supplies; inability to obtain or delays
of transportation facilities; any act of God; or any cause (whether similar or
dissimilar to the foregoing) beyond the reasonable control of a party (a "Force
Majeure Event"). Except as provided in Sections 6.7.1 and 7.1, if a Force
Majeure Event occurs, then the affected party's performance shall be excused and
the time for performance shall be extended for the period of delay or inability
to perform due to such occurrence.
6.7.1 If any Force Majeure Event shall delay any shipment hereunder
or the receipt thereof for more than [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION
10
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] beyond
the scheduled delivery date, then (a) if such Force Majeure Event is suffered by
Novartis and not also by Supplier, Supplier shall have the right, at its option,
to cancel such shipment without incurring any liability to Novartis with respect
thereto, and (b) if such Force Majeure Event is suffered by Supplier and not
also by Novartis, Novartis shall have the right to cancel its order and to
purchase from a third party the amount of Product ordered without incurring any
liability to Supplier with respect thereto until such time as Supplier is able
to perform its obligations hereunder.
6.8 From time to time Supplier may provide Novartis with safety and
health information, including, without limitation, warnings, material safety
data sheets, precautionary safety measures, and instructions on proper care, use
and handling, storage, and disposal of the Product. Novartis agrees to observe
all precautions and instructions provided by Supplier and to communicate all
such environmental, safety and health information to its employees. Novartis
shall follow safe handling, storage, transportation, use and disposal practices
with respect to the Product.
7. MEETING PRODUCT SUPPLY DEMANDS; BACK-UP SUPPLIER; RIGHT TO MANUFACTURE
7.1 In the event that, for any reason, Supplier is unable to supply
conforming Product sufficient to meet Novartis' purchase orders made consistent
with Section 3.2 in any material respect (an "Inability To Supply"), Novartis
shall have the immediate right, exercisable upon written notice within
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***] after any such event, to manufacture and
package Product with a supplier other than Supplier (a "Back-Up Supplier").
Notwithstanding the foregoing, if Supplier's Inability To Supply is the result
of an Exceptional Event (as defined below), then Novartis may not exercise its
right to manufacture and package Product with a Back-Up Supplier until
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***] after the commencement of the applicable
Exceptional Event. If Novartis exercises its right pursuant to this Section 7.1
to utilize a Back-Up Supplier then the parties shall work together diligently to
establish a Back-Up Supplier in accordance herewith. In the event that any
Inability To Supply shall continue for more than [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***], then Novartis may immediately terminate this Agreement without
liability to Supplier by giving Supplier [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]
prior written notice of termination, and this Agreement shall terminate on such
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***] unless prior thereto performance under
this Agreement resumes and Supplier so notifies Novartis in writing.
7.1.1 Novartis shall act as Back-Up Supplier, utilizing the Novartis
Manufacturing Facility, unless Novartis determines, in its sole discretion, that
an interruption of
11
Product supply could result if the Novartis Manufacturing Facility is used, in
which event, Novartis shall have the right to have a third party supplier of
Novartis' choice (and reasonably acceptable to Supplier) act as Back-Up
Supplier.
7.1.2 Supplier shall cooperate fully with Novartis and the Back-Up
Supplier, and shall use commercially reasonable best efforts to enable Back-Up
Supplier to qualify and validate the Back-Up Supplier's facilities and to
manufacture and package the Product. Supplier shall give Back-Up Supplier prompt
and unrestricted access to, or, if requested, Supplier immediately shall provide
to Back-Up Supplier, all Technical Information. Any disclosure or use of
Technical Information will be subject to the confidentiality restrictions set
forth in Article 8 of this Agreement. Back-Up Supplier shall have the right to
observe the operation of any laboratory and manufacturing and/or packaging
facility of Supplier (subject to Supplier's obligations of confidentiality to
third parties) and to have a reasonable number of employees or other
representatives of Supplier visit the Back-Up Suppliers' facilities, at
Novartis' option and in accordance with a mutually agreed time table, to
demonstrate and explain any of the Technical Information and the manufacturing
and packaging processes.
7.1.3 In the event that Novartis has the Back-Up Supplier
manufacture and/or package Product pursuant to this Section 7.1, then Novartis
shall pay to Supplier an amount equal to the amounts that Novartis would have
owed Supplier pursuant to Section 7.3.2. In such an event, Novartis shall not be
obligated to make any payment to Supplier pursuant to Section 7.3.3.
7.1.4 For purposes of this Agreement, the term "Exceptional Event"
shall mean a Force Majeure Event which, at the time of its commencement, the
parties reasonably expect would be resolved within [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***] from the date of its commencement.
7.2 If Supplier is unable to supply conforming Product in accordance
with Novartis' firm orders made pursuant to and in accordance with the terms and
conditions of this Agreement, and as a direct result of Supplier's
nonperformance, (i) Novartis is unable to supply Product to the marketplace,
(ii) an out-of-stock condition ensues at the Novartis warehouse and (iii)
Novartis receives backorders for the Product, then Novartis shall have the
remedy set forth in Section 4.2.5 of the License Agreement. Failure by Supplier
to supply Product ordered pursuant to a change order issued to Supplier pursuant
to Section 3.3 hereof which increased the order for the related month above
Novartis' forecast shall not be considered nonperformance by Supplier for
purposes of this Section 7.2.
7.3 In consideration for the payments made to Supplier under the License
Agreement and this Agreement, Novartis shall have the option to manufacture
and/or package the Product, and/or have a third party supplier of Novartis'
choice (and reasonably acceptable to Supplier) ("Third Party Supplier")
manufacture and/or package the Product and any future pharmaceutical product
developed using the OraSolv Technology with respect to which Novartis licenses
rights from Supplier. Novartis may exercise such right, by [***CONFIDENTIAL
TREATMENT
12
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***] written notice to Supplier, at any time.
7.3.1 Supplier shall cooperate fully with Novartis and the Third
Party Supplier, if any, and shall use commercially reasonable best efforts to
enable Novartis and/or the Third Party Supplier to qualify and validate the
Novartis Manufacturing Facility or the Third Party Supplier's facilities and to
manufacture and package the Product. Supplier shall give Novartis and the Third
Party Supplier prompt and unrestricted access to, or, if requested, immediately
shall provide to Novartis and the Third Party Supplier, all Technical
Information. Any disclosure or use of Technical Information will be subject to
the confidentiality restrictions set forth in Article 8 of this Agreement.
Novartis and/or the Third Party Supplier shall have the right to observe the
operation of any laboratory and manufacturing and/or packaging facility of
Supplier (subject to Supplier's obligations of confidentiality to third parties)
and to have a reasonable number of employees or other representatives of
Supplier visit the Novartis Manufacturing Facility or the Third Party Supplier's
manufacturing and/or packaging facilities upon reasonable notice and during
normal business hours, at Novartis' option and in accordance with a mutually
agreed time table, to demonstrate and explain any of the Technical Information
and the manufacturing or packaging processes.
7.3.2 Novartis shall reimburse Supplier for all reasonable,
pre-approved and fully-documented costs and expenses, including the cost of
reasonable personnel time, development, scale-up and validation costs, and other
out-of-pocket expenses actually incurred by Supplier in connection with the
technology transfer anticipated by this Section 7.3.
7.3.3 In the event Novartis elects to exercise this option, Novartis
will pay to Supplier total transfer costs not to exceed [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION***] according to the following payment schedule:
1. Upon exercising this option [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]
2. Upon order of equipment [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]
3. Upon completion of installation of equipment [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***]
4. Upon completion of validation of equipment [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***]
13
Notwithstanding the foregoing, if the license granted to Novartis under the
License Agreement has been converted to a fully paid-up, royalty-free,
irrevocable, nonexclusive license under the CIMA Patents and Know-How pursuant
to Section 8.5 of the License Agreement and, therefore, Novartis has rights to
the Technical Information pursuant to that Section 8.5, Novartis shall not be
required to make any payments to Supplier under this Section 7.3 upon exercising
the option to manufacture and/or package the Product.
7.4 For purposes of this Agreement, the following terms shall have the
meaning set forth below:
7.4.1 "Novartis Manufacturing Facility" shall mean a manufacturing
and/or packaging facility of Novartis or a Novartis Affiliate.
7.4.2 "Technical Information" means all know how, trade secrets,
inventions, data, technology and other information now owned or licensed by
Supplier or hereafter acquired or licensed by Supplier during the term of this
Agreement, including that related to the OraSolv Technology (as defined in the
License Agreement) which are necessary or useful to the manufacture, packaging,
use or sale of Products including, but not limited to, (i) medical, chemical and
other scientific data, (ii) processes and analytic methodology used in the
validation, stability testing and other testing or analysis of such Products and
(iii) packaging and manufacturing data and processes.
8. TRADE SECRETS, CONFIDENTIALITY AND PUBLICITY
8.1 Article 7 of the License Agreements incorporated herein by
reference.
9. QUALITY OF THE PRODUCT; COMPLIANCE WITH LAW
9.1 Supplier hereby represents and warrants that:
9.1.1 no Products constituting or being a part of any shipment
hereunder shall at the time of any such shipment be (i) adulterated or
misbranded within the meaning of the Federal Food, Drug and Cosmetic Act, as
amended from time to time (the "Act"), or regulations promulgated thereunder, as
such law or regulation is constituted and in effect at the time of any such
shipment, or (ii) an article which may not, under the provisions of Sections
404, 505 or 512 of the Act, be introduced into interstate commerce;
9.1.2 all Products furnished to Novartis hereunder shall be in full
compliance with the Specifications at the time of delivery, and shall remain in
full compliance with the Specifications for the full period of the expected
shelf-life of such Products, so long as the Products are stored in accordance
with the Specifications (absent convincing proof to the contrary, proper storage
shall be determined by comparing delivered Product with Product from the same
production lot which Supplier has held as a retained sample; if only the
delivered Product is non-compliant then the failure shall be deemed to be the
result of improper storage);
14
9.1.3 Supplier shall perform its obligations hereunder in compliance
with all applicable federal, state and local laws and regulations, including
without limitation the Act, FDA's then current Good Manufacturing Practices
("cGMP"), and any and all health, safety and environmental laws and regulations
applicable to Supplier's operations and performance hereunder;
9.1.4 all Products furnished to Novartis hereunder shall have been
manufactured in accordance with the terms of the QA Agreement;
9.1.5 Supplier has complied with, and during the term of this
Agreement will continue to comply with, the laws, rules and regulations which
affect the ability of Supplier to manufacture and package the Products in
commercial quantities for use and sale in the Territory;
9.1.6 Supplier's manufacturing, laboratory and packaging facilities
shall remain in compliance with cGMP at all times during the term of this
Agreement to the extent applicable to the manufacture and packaging of the
Products;
9.1.7 Supplier has disclosed to Novartis all material information
concerning Supplier's facilities and Supplier's ability to perform its
obligations hereunder which is in Supplier's possession as of the date this
Agreement is executed by Supplier, and will use reasonable best efforts to
continue to disclose such information to Novartis in the future, promptly after
receiving or becoming aware of it; and
9.1.8 the title conveyed on all Products furnished to Buyer
hereunder shall be good, and its transfer rightful, and the Products shall be
delivered free from any security interest or other lien or encumbrance.
9.2 EXCEPT AS OTHERWISE SPECIFICALLY PROVIDED IN THIS AGREEMENT,
SUPPLIER MAKES NO WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, CONCERNING THE
PRODUCTS, OR THE MERCHANTABILITY OR FITNESS THEREOF FOR ANY PURPOSE.
9.3 In the event that Products are delivered to Novartis by Supplier
which are not in compliance with the warranties made in Section 9.1 then, at
Novartis' option (i) Supplier shall replace the non-compliant Products at no
additional charge (which replacement Products shall be delivered to Novartis as
soon as reasonably practicable, but in no event more than sixty (60) days after
the initial notification by Novartis); or (ii) Supplier shall credit Novartis'
account in the amount of the price of the non-compliant Products.
10. INDEMNIFICATION AND INSURANCE
10.1 Novartis agrees to defend, indemnify and hold harmless Supplier
against any and all claims, damages, expenses, reasonable attorneys' fees,
settlement amounts and judgments arising out of any personal injury, bodily
injury or property damage to a third party alleged to have been caused by the
Products, except to the extent that such injury or damage was the result of any
breach of this Agreement by Supplier, including any warranty contained herein,
or
15
the result of any latent defects in the Products caused by the negligence or
willful misconduct of Supplier. Supplier shall promptly notify Novartis of any
such claim or action, shall reasonably cooperate with Novartis in the defense of
such claim or action, and shall permit Novartis to control the defense and
settlement of such claim or action, all at Novartis' cost and expense.
10.2 Supplier shall defend, indemnify and hold Novartis harmless against
any and all claims, damages, expenses, attorneys' fees, settlement amounts,
royalty fees, and judgments arising out of (i) any claim of personal injury,
bodily injury or property damage to a third party to the extent that such injury
or damage is the result of (a) any breach of this Agreement by Supplier,
including any warranty contained herein, or (b) any claim regarding latent
defects in the Products caused by the negligence or willful misconduct of
Supplier; or (ii) any claim regarding a work-related injury to any Supplier
employee. Novartis shall promptly notify Supplier of any such claim or action,
shall reasonably cooperate with Supplier in the defense of such claim or action,
and shall permit Supplier to control the defense and settlement of such claim or
action, all at Supplier's cost and expense.
10.3 Supplier shall obtain, at its own expense, a policy of insurance in
amounts no less than those specified below:
10.3.1 naming Novartis as an additional insured on a policy of
general liability insurance with combined limits of not less than $1,000,000 per
occurrence and $1,000,000 per accident for bodily injury, including death, and
property damage;
10.3.2 workers' compensation and disability insurance in the amounts
required by the law of the state(s) in which its workers are located, and
employer's liability insurance with limits of not less than $1,000,000 per
occurrence;
10.3.3 naming Novartis as an additional insured on a policy of
product liability insurance with limits not less than $1,000,000;
10.3.4 property insurance for the replacement value of the
facilities and equipment used to produce the Products; and
10.3.5 naming Novartis as an additional insured on a policy of
excess insurance with limits not less than $5,000,000.
10.4 Supplier shall provide to Novartis evidence of its insurance.
Supplier shall provide Novartis thirty (30) days prior written notice of any
cancellation or change in coverage.
10.5 Novartis warrants that it maintains a policy or program of insurance
or self-insurance at levels sufficient to support the indemnification
obligations assumed herein. Upon request, Novartis shall provide to Supplier
evidence of its insurance. Novartis shall provide to Supplier thirty (30) days
prior written notice of any cancellation or change in coverage.
10.6 THE EXPRESS OBLIGATIONS STATED IN THIS ARTICLE 10 AND IN ARTICLES 4
AND 9 ARE IN LIEU OF ALL OTHER LIABILITIES OR OBLIGATIONS OF
16
SUPPLIER FOR DAMAGES, INCLUDING BUT NOT LIMITED TO DIRECT OR CONSEQUENTIAL
DAMAGES, ARISING OUT OF OR IN CONNECTION WITH THE DELIVERY, USE OR PERFORMANCE
OF SUPPLIER'S PRODUCTS.
11. TERM AND TERMINATION
11.1 This Agreement shall commence on the Effective Date hereof and shall
continue in effect for [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] (the "Initial
Term") and, thereafter, subject to agreement on pricing pursuant to Section
11.1.3, shall automatically renew for an unlimited number of [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION***] periods (the "Renewal Terms").
11.1.1 Novartis may terminate this Agreement at no cost, effective
at the end of the Initial Term or at the conclusion of any Renewal Term, by
giving Supplier at least [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] prior written
notice of such termination.
11.1.2 Novartis may terminate this Agreement in accordance with the
provisions of Section 7.1.
11.1.3 Subject to Section 11.1.1, commencing on or about
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***] prior to the conclusion of the Initial
Term or any Renewal Term, the parties shall meet to negotiate pricing for the
Products for one (1) or more Renewal Terms.
11.1.3.1 If the parties reach such an agreement on price, then
this Agreement shall be deemed to be renewed and Supplier shall continue to
supply the Products to Novartis in accordance with the terms and conditions set
forth herein.
11.1.3.2 In the event that the parties are unable to reach an
agreement on price by the end of the Initial Term, then this Agreement shall be
deemed to be automatically renewed for a period of [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***] from the end of the Initial Term (the "Transition Term"), with no
further right of automatic renewal. In such an event, (i) during the Transition
Term, Supplier shall charge Novartis the Transition Price (as defined below) for
Products; and (ii) should Novartis choose to transfer production of the Products
to Novartis or to a Novartis facility or to a Third Party Supplier pursuant to
Section 7.3, then Novartis shall pay to Supplier an amount equal to the amounts
that Novartis would otherwise have owed Supplier pursuant to Section 7.3.2 and
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
17
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] of the amounts that
Novartis would otherwise have owed Supplier pursuant to Section 7.3.3.
11.1.3.3 For purposes of this Agreement, the term "Transition
Price" for any Product shall mean the price which Supplier charged Novartis for
the Product in accordance with this Agreement during the final year of the
Initial Term, adjusted so as to permit Supplier to earn a percent profit margin
on the Product which is [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] than the
average percent profit margin which Supplier actually earned on the manufacture
of prescription drug products during the final year of the Initial Term. By way
of example, if the average profit margin which Supplier actually earned on the
manufacture of prescription drug products during the final year of the Initial
Term was [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION***], then the price which Supplier
charged Novartis for the Products in accordance with this Agreement during the
final year of the Initial Term would be adjusted so as to permit Supplier to
earn a [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION***] profit margin on the Products.
The Transition Price (including the profit margin data on which it is based)
shall be subject to review by a CPA Firm in accordance with Section 2.6.
11.2 In the event that either party shall materially breach this
Agreement, the other party shall give such party written notice specifying such
breach with reasonable detail. Should the breaching party fail to cure such
breach within [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] of its receipt of
such notice, then the other party may terminate this Agreement. In addition,
either party may terminate this Agreement with immediate effect upon giving
written notice to the other party in the event of insolvency, assignment for the
benefit of creditors, or bankruptcy proceedings by or against the other party.
11.3 In order to permit Novartis to make a smooth transition to a new
supplier of Products, in the event that this Agreement should terminate for any
reason other than a termination pursuant to Section 11.2 due to the material
breach of Novartis, then Novartis shall be permitted, in its discretion, to
continue to submit purchase orders to Supplier in accordance with Section 3.2,
and Supplier shall continue to supply Products to Novartis in accordance with
such purchase orders and this Agreement, for a period of [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION***] after the termination of this Agreement, and this
Agreement shall remain in effect with respect to such purchase orders until the
expiration or termination of the purchase orders.
11.4 Notwithstanding any termination of this Agreement, the provisions of
Sections 6.5.2, 7.2, 7.3, 7.4, 8, 9, 10, 11.3 and 13 shall remain in effect.
Notwithstanding the foregoing, in the event that this Agreement is terminated
pursuant to Section 11.2 due to the material breach of Novartis, then Novartis
may not exercise its rights under Section 7.3 until it has cured such breach,
and, in any event, Novartis shall exercise any rights under Section 7.3
18
within [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION***] after the termination of this
Agreement.
12. AUDIT AND INSPECTION RIGHTS
12.1 During the term of this Agreement and any extension thereof,
Novartis shall have the right, at its sole cost and expense, to send Novartis
representatives to audit, inspect and observe the manufacture, storage, disposal
and transportation of the Products, and all other materials related thereto or
used in connection therewith, with reasonable notice during normal business
hours. Such Novartis representatives shall have no responsibility for
supervision of Supplier employees performing the manufacture, storage, disposal
or transportation operations themselves. The audit and inspection rights set
forth in this Section 12.1 are for the purpose of determining Supplier's
compliance with the terms of this Agreement.
12.2 Supplier shall make available to Novartis all records and reports
relating to the manufacture, storage, disposal and transportation of the
Products, and all other materials related thereto or used in connection
therewith, including without limitation those documents relating to analytical
data, for Novartis' review during normal business hours and upon reasonable
prior notice, and Novartis shall have the right to copy these documents as
required. Such records and reports shall be subject to the confidentiality
provisions of Section 8 of this Agreement. Novartis shall have the right to
conduct inventory reconciliation audits and other audits as reasonably required
for its internal control, at Novartis' sole cost and expense.
12.3 If, as a result of any such inspection, Novartis concludes that
Supplier is not in compliance with any of its obligations hereunder, it shall so
notify Supplier in writing, specifying such areas of noncompliance in reasonable
detail. Supplier shall provide to Novartis within [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***] of Novartis' request a written action plan satisfactory to
Novartis, with a time line for resolution of the problems identified within a
reasonable, mutually agreed upon time frame.
12.4 Supplier shall inform Novartis within [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***] of any notification to Supplier of any site visits to any of
Supplier's facilities by the FDA, state or federal regulatory agencies or any
other governmental or regulatory agency, directly relating to the manufacture of
the Products, and shall provide to Novartis all other materials related thereto
or used in connection therewith. Novartis shall have the option of participating
in any site visit by any governmental or regulatory agency, if the site visit
directly relates to the manufacturing, storage, disposal and transportation of
the Products , subject to such reasonable restraints on such participation as
Supplier may reasonably require. Should Novartis not participate in the site
visit, Supplier shall report in writing the results of the visit to Novartis
within [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION***] of the occurrence thereof. In
the event that any such governmental or regulatory agency finds that the site is
deficient or unsatisfactory in any respect, Supplier shall
19
cure all deficiencies within the earlier of [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***] or such cure period as ordered by the government or regulatory
agency. If all deficiencies are not cured within the required time frame,
Novartis shall have the option to immediately terminate this Agreement, without
liability.
12.5 In the event that any provision of Article 12 should conflict with
any provision of the QA Agreement, then the applicable provision of the QA
Agreement shall take precedence over the applicable provision of this Agreement.
13. MISCELLANEOUS
13.1 Each party acknowledges and agrees that any failure on the part of
the other party to enforce at any time, or for any period of time, any of the
provisions of this Agreement shall not be deemed or construed to be a waiver of
such provisions or of the right of such other party thereafter to enforce each
and every such provision.
13.2 If and to the extent that any provision of this Agreement is
determined by any legislature, court or administrative agency to be, in whole or
in part, invalid or unenforceable, such provision or part thereof shall be
deemed to be surplusage and, to the extent not so determined to be invalid or
unenforceable, each provision hereof shall remain in full force and effect
unless the purposes of this Agreement cannot be achieved. In the event any
provisions shall be held invalid, illegal or unenforceable the parties shall use
commercially reasonable efforts to substitute a valid, legal and enforceable
provision which insofar as practical implements the purposes hereof.
13.3 This Agreement shall be governed by, and construed in accordance
with, the laws of the State of New York as though made and to be fully performed
in said State.
13.4 All notices required or permitted hereunder shall be given in
writing and sent by facsimile transmission, or mailed postage prepaid by
first-class certified or registered mail, or sent by a nationally recognized
express courier service, or hand-delivered to the following addressees:
Novartis: Novartis Consumer Health, Inc.
000 Xxxxxx Xxxxxx
Xxxxxx, XX 00000
Attn: General Counsel
Supplier: CIMA LABS INC.
00000 Xxxxxx Xxxx Xxxx
Xxxx Xxxxxxx, XX 00000
Attn: Vice President, Business Development
or to such other address as may be specified in a notice given to the other
party in accordance with this Section. Any notice, if sent properly addressed,
postage prepaid, shall be deemed made
20
three (3) days after the date of mailing as indicated on the certified or
registered mail receipt, or on the next business day if sent by express courier
service or on the date of delivery or transmission (if delivered or sent during
ordinary business hours, otherwise on the next business day) if hand-delivered
or sent by facsimile transmission.
13.5 The captions of each section of this Agreement are inserted only as
a matter of convenience and for reference and in no way shall be deemed to
define, limit, enlarge, or describe the scope of this Agreement and the
relationship of the parties hereto, and shall not in any way affect this
Agreement or the construction of any provisions herein.
13.6 This Agreement, including all Exhibits annexed hereto (which are
incorporated herein by reference), represents and incorporates the entire
understanding between the parties hereto with respect to the subject matter of
this Agreement, and each party acknowledges that there are no warranties,
representations, covenants or understandings of any kind, nature or description
whatsoever made by any party to any other, except such as are expressly set
forth herein. This Agreement shall not be subject to change or modification
except by the execution of a writing specified to be an explicit amendment to
this Agreement duly executed by all parties hereto. Notwithstanding the
foregoing, the terms and conditions set forth in this Agreement shall take
precedence over any contrary or inconsistent terms and conditions appearing or
referred to in any Exhibits annexed hereto, unless the Exhibit explicitly states
otherwise.
13.7 The parties recognize that, during the term of this Agreement, a
purchase order, acknowledgment form or similar routine document (collectively,
"Forms") may be used to implement or administer provisions of this Agreement.
Therefore, the parties agree that the terms of this Agreement shall prevail in
the event of any conflict between this Agreement and the printed provisions of
such Forms, or typed provisions of Forms that add to, vary, modify or are at
conflict with the provisions of this Agreement.
13.8 Nothing in this Agreement shall create between the parties a
partnership, joint venture or principal-agent relationship and, for the
avoidance of doubt, each of Supplier and Novartis now confirms and accepts that
it is an independent contractor trading for and on its own behalf.
13.9 Neither party hereto shall assign or otherwise transfer any of its
rights or obligations under this Agreement, in whole or in part, without the
prior written consent of the other party, except that either party may, without
the necessity for such consent, assign this Agreement or any interest herein or
any right hereunder, to any of its Affiliates or successors by merger or sale of
all or substantially all of its business unit to which this Agreement relates.
This Agreement shall be binding upon any permitted Assignee or successor of
either party. Any assignment that is not in accordance with this Section 13.9
will be void.
13.10 Novartis shall have the right, not to be unreasonably exercised, to
disapprove of any subcontractor or sub-subcontractor retained or to be retained
to assist Supplier in the performance of its obligations hereunder. Any such
approval or disapproval shall not relieve Supplier of its obligations under this
Agreement. Supplier may not make use of the services of
21
any subcontractor or sub-subcontractor in the performance of the Services if
Novartis has disapproved of that subcontractor or sub-subcontractor.
13.11 This Agreement may be executed in two or more counterparts, each of
which shall constitute an original and all of which together shall constitute a
single instrument.
13.12 This Agreement is understood and accepted by Supplier as a general
Novartis Agreement that facilitates application to all Novartis Affiliates in
the world. Due to Affiliate-specific requirements relating to product supply, it
is further recognized and agreed that each Novartis Affiliate will finalize
their specific supply details, including Annexes if the Affiliate so elects,
separately with Supplier; provided, however, that Supplier agrees (1) to the
extent volume discounts are then available to Novartis, as Novartis Affiliate
incremental volume is added to total Product production, pricing for the Product
to all Novartis Affiliates will be discounted to appropriately reflect the
increase in total Novartis and Novartis Affiliate volume for Product meeting the
criteria set forth in (2)(a) - (c) of this Section 13.12; and (2) each Novartis
Affiliate shall be entitled to, but not bound by, financial terms no less
favorable than the terms set forth in Article 2 hereof for manufacture and
packaging by Supplier of a product of (a) the same formulation and dosage as the
Product, (b) packaged in the same blister packaging and, (c) in the same pack
count. Pricing for external packaging and labeling shall be negotiated in good
faith by Supplier and the Novartis Affiliate; provided, that, such pricing is
based on competitive costing.
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of
the day and year first above written.
CIMA LABS INC. NOVARTIS CONSUMER HEALTH, INC.
By: /s/ Xxxx X. Xxxxxxx By: /s/ Xxx Xxxxxx
------------------- --------------
Name: Xxxx X. Xxxxxxx Name: Xxx Xxxxxx
Title: President & CEO Title: Sr VP Supply Chain
Date: 2 September 2001 Date: 8/24/01
Ver. Fixed 01/1-4
22
EXHIBIT A
List of current Novartis Triaminic Softchews SKU's as of January 1, 2001:
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]
EXHIBIT B
Novartis Consumer Health. Inc.
000 Xxxxxx Xxx.
Xxxxxx, Xxx Xxxxxx 00000
NOVARTIS Tele: (000) 000-0000
Fax: (000) 000-0000
QUALITY AGREEMENT INDEX & CONTACT LIST
Date: May 16, 2000
To: CIMA
cc: ###, Legal, QACS File, QACS Product Manual
Document: CIMA Revision No.:
02
Quality Assurance Agreement for CIMA
CIMA 01
Attachment Attachment Title Attachment
Number Revision
Number
A.01 Testing requirements for Triaminic(R) Softchew(R) 01
Tablets
B.01 Validation requirements for Triaminic(R) Softchew(R) 01
Tablets
C.01 Contractor guideline for Triaminic(R) Softchew(R) 01
Tablets
D.01 Quality Control line check and sampling procedure for 00
Triaminic(R) Softchew(R) Tablets, per CIMA SOP ###
E.01 Approved Supplier list for Triaminic(R) Softchew(R) 01
Tablets
CIMA Address: 00000 Xxxxxx Xxxx Xxxx
Xxxx, Xxxxx Xxx
Xxxx Xxxxxxx, XX 00000
Key Contacts at Novartis Key Contacts at CIMA
Name Telephone No. Name Telephone No.
###, Manager Quality ### ###, Director QC ###
Assurance Contract Supply
Xxxx Xxxxxxxx 000-000-0000
VP Regulatory Compliance
Approved by NCHIs QACS: /s/ ### Date: 25 May 00
--------------------- ---------------
### - [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]
Approved by CIMA: /s/ X. Xxxxxxxx Date: 25 May 00
------------------------- ---------------
CHANGE HISTORY
Reason for Change: 3/30/2000--Document revised to add information specific to
SKU ### TRIAMINIC(R) Softchews(R) Cough - 1/2" Strawberry - ###
### - [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION***]
QUALITY ASSURANCE CONTRACT SUPPLY AGREEMENT CIMA - 001
TESTING REQUIREMENTS FOR TRIAMINIC(R) SOFTCHEW(R) TABLETS
================================================================================
TESTING REQUIREMENTS FOR RAW MATERIALS, COMPONENTS, AND
PACKAGED PRODUCT
SKU Product Code No.:
--------------------------------------------------------------------------------
SKU ### Triaminic(R) Softchews(R) Cold & Allergy 1/2" Orange ###
SKU ### Triaminic(R) Softchews(R) Cough & Cold 1/2" Cherry ###
SKU ### Triaminic(R) Softchews(R) Throat Pain & Cough, 5/8" ###
Grape
SKU ### Triaminic(R) Softchews(R) Cough-Strawberry ###
================================================================================
Testing per Approved Blend Product Specification(s), and referenced on the
Certificate of Analysis -- BLEND TESTING
[ ] N/A [ ] Full Testing [X] Reduced Testing(explain below)
Explanation: Per specifications; ###
================================================================================
Testing per Approved Product Specification(s), and referenced on the Certificate
of Analysis -- PACKAGED PRODUCT TESTING / FINISHED PRODUCT TESTING
[ ] N/A [ ] Full Testing [X] Reduced Testing(explain below)
Explanation: Per specifications; ###
================================================================================
Testing per Approved Raw Material Specifications - RAW MATERIAL TESTING
[ ] N/A [ ] Full Testing [X] Reduced Testing(explain below)
Explanation: Per SOP ### & raw material specifications.
================================================================================
Testing per Approved Component Specifications -- COMPONENT TESTING / PACKAGING
MATERIALS
[ ] N/A [ ] Full Testing [X] Reduced Testing(explain below)
Explanation: Per packaging specifications.
================================================================================
FOR REFERENCE ONLY - KEY STANDARD OPERATING PROCEDURE(s)
SOP #: OOS / Retest SOP ###
SOP #: Reduced Testing & Supplier Qualification Program ###
SOP #: Vendor Audit Program ###
SOP #: Quality Control Line Check and Sampling Procedure for Triaminic(R)
Softchews(R), SOP # ###
================================================================================
### - [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION***]
QUALITY ASSURANCE CONTRACT SUPPLY AGREEMENT CIMA - 001
VALIDATION REQUIREMENTS FOR TRIAMINIC(R) SOFTCHEW(R) TABLETS
================================================================================
Product: Code: NCHI Package List No.:
--------------------------------------------------------------------------------
Triaminic(R) Softchews(R) Cold & ### ###
Allergy 1/2" Orange
Triaminic(R) Softchews(R) Cough ### ###
& Cold 1/2" Cherry
Triaminic(R) Softchews(R) Throat ### ###
Pain & Cough, 5/8" Grape
================================================================================
Validation Area Required Validation Completed
(Check box below if completed)
--------------------------------------------------------------------------------
Manufacturing Process [X] Yes [ ] No [ ]
Cleaning [X] Yes [ ] No [ ]
Validation
Packaging Process [X] Yes [ ] No [ ]
Cleaning [X] Yes [ ] No [ ]
Validation
Child Resistant [X] Yes [ ] No [X] SKU ### only. NCHI approval
Testing letter dated Oct. 29, 0000
Xxxxx Product [X] Yes [ ] No Copy of Data Obtained Lot
Expiration Dating [ ] Yes [ ] No Numbers:
Blend Product [X] Yes [ ] No [ ] Poly drums with plastic
Storage Conditions liner over the lid, less than 25
grains/lbs of air.
Test Method(s) [X] Yes [ ] No [ ]
Transfer Required
Cross Validation [X] Yes [ ] No [ ]
between laboratories
Test Method [X] Yes [ ] No [ ]
Validation Required
Stability Data [X] Yes [ ] No Copy of Data Obtained Lot
(Supports Expiry) [ ] Yes [ ] No Numbers:
================================================================================
Manufacturing and control procedures, including Cleaning Procedures must be
validated. CIMA will be responsible for process (manufacturing & packaging)
validation. CIMA will be responsible for cleaning validation. CIMA will be
responsible for analytical testing validation. CIMA will be responsible for
IQ/OQ and equipment validation. The validation responsibility included
performance of validation and maintenance of the associated documentation is
CIMA responsibility. CIMA will provide NCHIs QACS with the validation protocols
for review and approval prior to implementation. The final validation report(s)
will be sent to NCHIs QACS for review and approval upon completion of validation
activities.
### - [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION***]
QUALITY ASSURANCE CONTRACT SUPPLY AGREEMENT CIMA - 001
VALIDATION REQUIREMENTS FOR TRIAMINIC(R) SOFTCHEW(R) TABLETS
================================================================================
Product: Code: NCHI Package List No.:
--------------------------------------------------------------------------------
Triaminic(R) Softchews(R) ### ###
Cough 1/2" Strawberry
================================================================================
Validation Area Required Validation Completed
(Check box below if completed)
--------------------------------------------------------------------------------
Manufacturing Process [X] Yes [ ] No [ ]
Cleaning [X] Yes [ ] No [ ]
Validation
Packaging Process [X] Yes [ ] No [ ]
Cleaning [X] Yes [ ] No [ ]
Validation
Child Resistant [ ] Yes [X] No [ ]
Testing
Blend Product [X] Yes [ ] No Copy of Data Obtained Lot
Expiration Dating [ ] Yes [ ] No Numbers:
Blend Product [X] Yes [ ] No [ ] Poly drums with plastic liner
Storage Conditions over the lid, less than 25
grains/lbs of air.
Test Method(s) [X] Yes [ ] No [ ]
Transfer Required
Cross Validation [X] Yes [ ] No [ ]
between laboratories
Test Method [X] Yes [ ] No [ ]
Validation Required
Stability Data [X] Yes [ ] No Copy of Data Obtained Lot
(Supports Expiry) [ ] Yes [ ] No Numbers:
================================================================================
Manufacturing and control procedures, including Cleaning Procedures must be
validated. CIMA will be responsible for process (manufacturing & packaging)
validation. CIMA will be responsible for cleaning validation. CIMA will be
responsible for analytical testing validation. CIMA will be responsible for
IQ/OQ and equipment validation. The validation responsibility included
performance of validation and maintenance of the associated documentation is
CIMA responsibility. CIMA will provide NCHIs QACS with the validation protocols
for review and approval prior to implementation. The final validation report(s)
will be sent to NCHIs QACS for review and approval upon completion of validation
activities.
### - [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]
QUALITY ASSURANCE CONTRACT SUPPLY AGREEMENT CIMA - 001
Title: Contractor Guideline for CIMA, Triaminic(R) Softchew(R) Tablets
Revision Number: 00 Supersedes: None
1. PURPOSE: This guideline will describe the sampling requirements (line
& legal retains), expiry term coding, lot coding, and batch record
content for Triaminic(R) Softchew(R) Tablets at CIMA.
2. SCOPE: This procedure applies to the following product Manufactured and/or
Packaged at CIMA.
Manufacturing
Product Code Number
--------------------------------------------------------------------------------
Triaminic(R) Softchews(R) Cough- 1/2" Strawberry ###
Triaminic(R) Softchews(R) Cold & Allergy 1/2" Orange ###
Triaminic(R) Softchews(R) Cough & Cold 1/2" Cherry ###
Triaminic(R) Softchews(R) Throat Pain & Cough, 5/8" Grape ###
3. RESPONSIBILITIES:
3.1. CIMA is responsible for complying with this procedure.
3.2. If CIMA can not comply with this procedure they must inform Novartis
Consumer Health, Inc. (NCHI) Quality Assurance Contract Supply
(QACS) in writing with the rationale and proposed changes for the
document.
3.3. QACS is responsible for the issuance, revision, and control of this
procedure.
3.4. Only QACS has the authority to change this procedure.
4. PROCEDURE:
RETAINS
4.1. From each batch/lot of product produced a minimum of three cases per
lot will be pulled evenly from the beginning, middle, and end of
every batch/lot of product. Ensure the product is labeled to
identify when and from where the samples were taken.
4.1.1. All retains and batch records will be forwarded to QACS at
the following address:
Novartis Consumer Health, Inc.
Quality Assurance Contract Supply
000 Xxxxxx Xxx
Xxxxxx, XX 00000-0000
### - [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION***]
4.2. EXPIRY TERM CODING
4.2.1. The expiration dating on the cartons must appear as follows:
- EXP 01/01
- Two digit month
- Two digit year
4.2.2. The expiration dating on the blister cards and shippers must
appear as follows:
- EXP 01/2001
- Two digit month
- Four digit year
QUALITY ASSURANCE CONTRACT SUPPLY AGREEMENT CIMA - 001
Contractor Guideline for CIMA, Triaminic(R) Softchew(R) Tablets
Revision Number: 00 Supersedes: None
Lot coding will adhere to a coding procedure using seven digits defined as
follows:
- First & second digit represents a particular product SKU:
- T1 - Triaminic(R) Softchew(R) Cold & Allergy, 1/2"
Orange.
- T2 - Triaminic(R) Softchew(R) Cold & Cough, 1/2"
Cherry.
- T3 - Triaminic(R) Softchew(R) Throat Pain & Cough, 5/8"
Grape.
- T5 - Triaminic(R) Softchew(R) Cough, 1/2", Strawberry
- Third digit represents the year, 1998 => 8.
- Fourth digit represents the month, Jan => A, Feb => B... (do
not use "I").
- Fifth & sixth digits represent a sequential number for the
month.
- Seventh digit will only be used if the bulk lot is split
during packaging, each portion must be assigned its own unique
lot number using an alpha suffix (i.e., A, B, C, etc.).
4.3. BATCH RECORD CONTENT - CIMA will maintain full manufacturing and
packaging batch records. The following batch record documents will
be forwarded to NCHIs ACS as outlined below:
Required in Batch
Record
YES NO Record(s)
X NCHI Purchase Order
X Batch Manufacturing Record (weighting & blending, compression,
blister packaging, & final packaging)
X Master Packaging Specification
X "CIMA Raw Material Test Form for all Actives"
X Vendor CofA for Active Raw Material(s)
X Finished Product CofA
X Product Reconciliation
X Component Reconciliation
X QC On-line Inspection Reports Manufacturing & Packaging
X Certificate(s) for Critical Components
X Copies of all Labeling
X QC Record(s) and test results for the Release of Blend
X QC Record(s) and test results for the Release of Raw Materials
X QC Record(s) and test results for the Release of Components
X QC Record(s) and test results for the Release of Finished Product
X Line Clearance & Set-up Documentation for the Manufacturing and
Packaging Process
X Documentation and/or Investigation for any Process Deviation(s)
X Documentation indicating that samples have been forwarded to the
outside or internal laboratory for Testing
X Cleaning and sanitization records.
X Packaging Waivers signed by the appropriate NCHI Departments
(Regulatory, Package Development, & Contract Operations).
X Manufacturing Deviations signed by NCHIs QACS.
QUALITY ASSURANCE CONTRACT SUPPLY AGREEMENT CIMA - 001
Title: Contractor Guideline for CIMA, Triaminic(R) Softchew(R) Tablets
Revision Number: 00 Supersedes: None
HISTORY PAGE
REVISION NO. DATE CHANGE
------------ ---- ------
02 3/30/2000 Added Information specific to Triaminic-
Softchew-Cough - Strawberry flavor SKU
QUALITY ASSURANCE CONTRACT SUPPLY AGREEMENT CIMA - 001
AQL'S & DEFECT CATEGORIES FOR PACKAGING AND FINISHED PRODUCT
TRIAMINIC(R) SOFTCHEW(R) TABLETS
Refer to CIMAs SOP ###.
### - [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION***]
QUALITY ASSURANCE CONTRACT SUPPLY AGREEMENT CIMA - 001
APPROVED SUPPLIER LIST FOR TRIAMINIC(R) SOFTCHEW TABLETS(R)
List all actives, excipients, and components used to manufacture/package
material for NCHL
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]
EXHIBIT C - TRIAMINIC PRICING
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]
Exhibit D Lead Times
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]
