EXHIBIT 10.6
AMENDED AND RESTATED
U.S. PRODUCT MANUFACTURING AGREEMENT
THIS AMENDED AND RESTATED U.S. PRODUCT MANUFACTURING AGREEMENT (the
"Agreement") dated as of February 27, 2006, is made and entered into by and
between SANOFI-AVENTIS DEUTSCHLAND GMBH (formerly known as HOECHST XXXXXX
XXXXXXX DEUTSCHLAND GMBH), a German limited liability company ("Supplier"), and
KING PHARMACEUTICALS, INC., a Tennessee corporation ("King"). Capitalized terms
used in this Agreement shall have the meanings ascribed to them in Article I
hereof or as otherwise set forth herein.
RECITALS
WHEREAS, Supplier is engaged in the manufacture of the Product;
WHEREAS, Supplier and King are parties to that certain U.S. Product
Manufacturing Agreement dated December 17, 1998, as amended June 22, 2000,
December 16, 2002 and September 13, 2004 (the "Original Agreement");
WHEREAS, Supplier and King have agreed to amend and restate the
Original Agreement;
WHEREAS, Supplier and King have also entered into that certain General
Products Agreement dated December 17, 1998, as amended (the "General Products
Agreement") whereby King acquired certain Assets (as such term is defined in the
General Products Agreement) which relate to, among other things, Ramipril;
WHEREAS, Supplier and King have entered into that certain U.S. Product
Agreement dated December 17, 1998, as amended (the "U.S. Product Agreement")
whereby King acquired, among other things, certain rights which relate to
Ramipril;
WHEREAS, King desires to have Supplier manufacture the Product in
accordance with this Agreement; and
WHEREAS, Supplier agrees to supply the Product to King, upon the terms
and subject to the conditions provided herein.
NOW, THEREFORE, in consideration of the mutual covenants and
agreements set forth in this Agreement, and for other good and valuable
consideration, the receipt of which is hereby acknowledged, the parties hereto
hereby agree as follows:
ARTICLE I
DEFINITIONS
The following terms shall have the meanings set forth below. Unless
the context indicates otherwise, the singular shall include the plural and the
plural shall include the singular.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
1.1. "ACT" shall mean the Federal Food, Drug and Cosmetic Act, as
amended.
1.2. "AFFILIATE" shall mean any entity that directly, or indirectly
through one or more intermediaries, controls or is controlled by or is under
common control with the entity specified.
1.3. "AGREEMENT" shall mean this U.S. Product Manufacturing Agreement.
1.4. "ANNUAL COMMITTED QUANTITY" shall have the meaning set forth in
Section 2.10(a) herein.
1.5. "ARBITRATING ACCOUNTANT" shall have the meaning set forth in
Section 3.2(d) herein.
1.6. "BUSINESS DAY" or "BUSINESS DAY" shall mean a day other than
Saturday, Sunday or any day on which banks located in the State of Missouri are
authorized or obligated to close. Whenever this Agreement refers to a number of
days, such number shall refer to calendar days unless Business Days (or business
days) are specified.
1.7. "CALENDAR QUARTER" shall mean, with respect to the first such
Calendar Quarter, the period beginning on the date hereof and ending on the last
day of the calendar quarter within which the date hereof falls and, thereafter,
each successive period of three consecutive calendar months ending on March 31,
June 30, September 30 or December 31. In the event that the termination of this
Agreement does not fall on the last day of a Calendar Quarter, the "Final
Calendar Quarter" shall mean the period from the last day of the most recent
Calendar Quarter through the applicable date of termination of this Agreement.
1.8. "CALENDAR YEAR" shall mean each successive twelve (12)-month
period commencing on January 1 and ending on December 31; provided that the
first such Calendar Year shall begin on the date hereof and end on December 31,
2006. In the event that the termination of this Agreement does not fall on the
last day of a Calendar Year, the "Final Calendar Year" shall mean the period
from the last day of the most recent Calendar Year through the applicable date
of termination of this Agreement.
1.9. "CGMP" shall mean current Good Manufacturing Practices as
promulgated under the Act at 21 CFR (chapters 210, 211, 600 and 610), as the
same may be amended or re-enacted from time to time.
1.10. "DISCRETIONARY MANUFACTURING CHANGES" shall have the meaning set
forth in Section 2.7(b) herein.
1.11. "EXCESS PRICE" shall have the meaning set forth in Section 3.1
herein.
1.12. "FDA" shall mean the United States Food and Drug Administration
or any successor entity thereto.
1.13. "FORCE MAJEURE" shall have the meaning set forth in Section 11.3
herein.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
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1.14. "GENERAL PRODUCTS AGREEMENT" shall have the meaning set forth in
the Recitals.
1.15. "GENERIC VERSION" shall have the meaning set forth in Section
2.9(f) herein.
1.16. "GOVERNMENTAL OR REGULATORY AUTHORITY" shall mean any court,
tribunal, arbitrator, authority, agency, commission, official or other
instrumentality of the United States, any foreign country or any domestic or
foreign state, county, city or other political subdivision.
1.17. "INDEMNITEE" shall have the meaning set forth in Section 9.3
herein.
1.18. "INDEMNITOR" shall have the meaning set forth in Section 9.3(a)
herein.
1.19. "INITIAL COSTS" shall have the meaning set forth in Section 3.1
herein.
1.20. "LIABILITIES" shall have the meaning set forth in Section 9.1
herein.
1.21. "LAWS" shall mean all laws, statutes, rules, regulations,
ordinances and other pronouncements having the effect of law of the United
States, any foreign country or any domestic or foreign state, county, city or
other political subdivision or of any Governmental or Regulatory Authority.
1.22. "LICENSED PRODUCTS" shall have the meaning ascribed to such term
in the U.S. Product Agreement.
1.23. "MINIMUM PRICE" shall have the meaning set forth in Section 3.1
herein.
1.24. "MINIMUM QUARTERLY PAYMENT" shall have the meaning set forth in
Section 2.9(b) herein.
1.25. "NDA" shall mean the new drug applications related to the
Products, submitted to the FDA pursuant to provisions of the Act and applicable
regulations related thereto.
1.26. "ORIGINAL AGREEMENT" shall have the meaning set forth in the
Recitals.
1.27. "PEDIATRIC EXTENSION" shall mean any pediatric exclusivity
extension that may be granted by the FDA to King for Licensed Mono-Product (as
defined in the U.S. Product Agreement).
1.28. "PEDIATRIC EXTENSION EXPIRATION DATE" shall mean the date of
expiration of any Pediatric Extension, provided that in no event will such date
extend beyond April 30, 2009.
1.29. "PRIME RATE" shall have the meaning set forth in Section 3.2(a)
herein.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
3
1.30. "PRODUCT(S)" shall mean Ramipril in either a (a) powder form or
(b) PC granules (i.e., coated) form intended for further processing into a
pharmaceutical formulation, the Specifications for which are set forth on
SCHEDULE 1.30, attached hereto.
1.31. "RAMIPRIL" shall mean the compound (2S,3aS,6aS)-1[(S)-N-[(S)-
1Carboxy-3-phenylpropyl]alanyl]octahydrocyclopenta[b]pyrrole-2-carboxylic acid,
1-ethyl ester, as depicted in the chemical formula set forth on SCHEDULE 1.31,
attached hereto.
1.32. "REQUIRED MANUFACTURING CHANGES" shall have the meaning set
forth in Section 2.7(a) herein.
1.33. "SPECIFICATIONS" shall mean the written specifications for
Products as set forth in the NDA.
1.34. "TECHNICAL AGREEMENT" shall mean the Agreement set forth on
EXHIBIT D, attached hereto.
1.35. "TERM" shall have the meaning set forth in Section 4.1 herein.
1.36. "THIRD PARTY" shall have the meaning set forth in Section 2.9(f)
herein.
1.37. "U.S. PRODUCT AGREEMENT" shall have the meaning set forth in the
Recitals.
1.38. "U.S. TERRITORY" shall mean the U.S. Territory as such term is
defined in the U.S. Product Agreement.
ARTICLE II
MANUFACTURE, PURCHASE AND
SALE OF PRODUCT; ANNUAL MINIMUMS
2.1. EXCLUSIVE SUPPLY; NON-COMPETE.
(a) Exclusive Supply. Pursuant to the terms and conditions of
this Agreement, Supplier agrees to manufacture exclusively for King (except
as permitted in the U.S. Product Agreement), during the Term, the Products
for King to make or have made, sell or use Licensed Products in the U.S.
Territory in accordance with the U.S. Product Agreement. During the Term,
King agrees to purchase all of its requirements for the Products in the
U.S. Territory exclusively from Supplier.
(b) Non-Compete. Except as permitted in the U.S. Product
Agreement, during the Term: (i) Supplier agrees that it will not, and will
cause its Affiliates to not, manufacture, package, distribute or sell in
the U.S. Territory the Product included in this Agreement; and (ii) King
agrees that it will not and will cause its Affiliates to not, manufacture,
package, distribute or sell the Product outside the U.S. Territory.
2.2. FORECASTS.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
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(a) Long-Range Forecasts. Within [***] from the execution of this
Agreement, and at least [***] prior to the beginning of each Calendar Year
for the Term or any renewals or extensions thereof, King shall furnish
Supplier with a rolling quarterly forecast of the quantities of Products
that King intends to order during the [***] commencing with the upcoming
Calendar Year. Such forecasts shall represent the most current estimates
for planning purposes, and will include the quantities of Product in either
powder or PC granules form, but shall not be purchase commitments.
(b) Short Term Forecasts. At least [***] prior to the first day
of each succeeding Calendar Quarter, King shall furnish Supplier with a
rolling forecast of the quantities of each Product, (i) Ramipril in powder
form and (ii) Ramipril in PC granules form, by kg, that King intends to
order by month, during the [***] period commencing with that Calendar
Quarter. Subject to the provisions of Section 2.9 and to the extent
Supplier can supply any quantities in excess of the Annual Committed
Quantity, such forecasts shall constitute binding commitments of King to
purchase the percentages of Products set forth below pursuant to firm
orders issued in accordance with Section 2.3. Supplier will use its
reasonable best efforts to fill orders by King in excess of the Annual
Committed Quantities:
Percentage of each Product
(in powder form and PC granules form)
Period of the Forecast that King is Required to Purchase
---------------------- -------------------------------------
[***] [***]%
[***] [***]%
[***] [***]%
[***] [***]%
[***] [***]%
[***] [***]%
2.3. FIRM ORDERS. King shall place each purchase order with Supplier
for Products to be delivered hereunder at least [***] prior to the delivery date
specified in each respective order. King acknowledges that each Product is
produced in full lot quantities, as set forth in EXHIBIT B. Such orders shall
specify Ramipril in powder form and/or Ramipril in PC granules form, by
kilogram, in full lots and minimum order quantities and shall specify [***] an
aggregate quantity of Products which is at least as great as the amount of
Products (in powder form and/or in PC granules form) required to be purchased by
King pursuant to Sections 2.2 and 2.9. In addition, the number of such purchase
orders shall not exceed [***] per month, unless a greater monthly number is
agreed to by Supplier, and, to the extent possible, be delivered to Supplier on
or about the fifteenth (15th) of such month. Supplier shall confirm in writing
each such purchase order within [***] of receipt thereof. Supplier shall deliver
against each such order in accordance with Section 2.4. King shall be obligated
to purchase all such Products ordered and delivered by the delivery date
specified in King's purchase order, provided that such Products meet the
Specifications. Unless otherwise specified in writing by Supplier, all orders
placed by King with Supplier hereunder shall be addressed as follows:
Manager of PharmaChemical Sales Germany
Sanofi-Aventis Deutschland GmbH
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
5
PharmaChemical Sales
Industriepark Hoechst
Gebaude / Building D 711
65926 Frankfurt am Main
Notwithstanding anything else in this Section 2.3 or in Section 2.4, if at any
time the amount of Product King is required to purchase in order to meet its
Quarterly Minimum Quantity or Annual Minimum Quantity is less than a full lot or
if King has met the Annual Minimum Quantity, King's orders and deliveries may be
in fractional, not full, lot quantities.
2.4. DELIVERY. Delivery terms for Products shall be F.O.B. Supplier's
manufacturing facility, or such other facility mutually agreed to by the
parties. Supplier shall ship Products on a carrier or carriers specified by King
and at King's expense in accordance with Supplier's purchase order form or as
otherwise directed by King in writing. Title and risk of loss as to any Products
purchased by King shall pass to King upon the earlier of (i) a common carrier
accepting possession or control of such Products, or (ii) the passage of such
Products from the loading dock of Supplier's facility to any employee, agent or
contractor of King or such common carrier. It is understood that all quantities
shipped shall be shipped in full lots, as set forth in EXHIBIT B.
2.5. REJECTED GOODS/SHORTAGES.
(a) Notice; Replacement. King shall notify Supplier in writing of
any claim relating to Products that fail to meet the Specifications,
arising from defective manufacture, storage or handling of such Products by
Supplier which occur prior to transfer of Product to King or any shortage
in quantity of any shipment of Products as soon as reasonably practical,
but not later than [***] (or [***] in the event an outside testing
laboratory is used) of receipt of such Products. Provided the parties agree
that such Products are defective or that there is a shortage, Supplier
shall replace the defective Products or make up the shortage at the time of
the next order, [***]. King shall make arrangements with Supplier for the
return or disposal of any rejected Products; the costs of such return or
disposal shall be paid [***]. In the event that only a limited supply of
Products is available to replace or supply such rejection or shortage, then
Supplier shall ship to King such quantities of Products as are available
and King will be promptly reimbursed or credited against future orders, at
King's option, for amounts paid for the remaining quantity of rejected
Products.
(b) Disputes. If Supplier disagrees with King's claim that such
Products fail to meet the Specifications, Supplier and King representatives
shall attempt to resolve such dispute. If the representatives cannot
resolve such dispute, a sample of such Products shall be submitted by
Supplier to a mutually agreed-to qualified laboratory for testing against
the Specifications and the test results obtained by such laboratory shall
be final and controlling. The fees and expenses of such laboratory testing
shall be borne [***]. In the event the test results indicate that the
Products in question do not conform to the Specifications, Supplier shall
replace such Products [***] to King as soon as reasonably possible after
receipt of such results. In the event the test results indicate that
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
6
the Products in question do conform to the Specifications, [***] costs
incurred by Supplier as a result of the disagreement.
(c) Sole Remedy. The provisions of Sections 2.5(a) in the case of
shortage in quantity of any shipment of Product, and except as otherwise
provided in Section 9.2(a) herein, Sections 2.5(a) and (b), in the case of
Product that fails to meet the Specifications, shall be the sole remedy
available to King with respect to any shortage in quantity of any shipment
of Product, or Product that fails to meet the Specifications, as the case
may be.
2.6. CAPACITY ALLOCATION; FAILURE TO SUPPLY.
(a) Capacity. Supplier's maximum annual capacity to manufacture
each Product is set forth on EXHIBIT B.
(b) Supplier Notice. In the event that Supplier, upon receiving a
forecast under Section 2.2(b) or a firm order under Section 2.3, is, or
anticipates that it will be, unable to meet such forecast or firm order,
either in whole or in part, due to any reason, Supplier shall give written
notice of such inability to King within [***] of receipt of such forecast
or firm order (or upon Supplier's reasonable belief that it cannot fulfill
the forecast or firm order, if such date is after such [***] period). If
such inability is partial, Supplier shall fulfill firm orders with such
quantities of Products as are available. Supplier shall consistently use
its commercially reasonable efforts to ensure that firm orders are supplied
in full on a timely basis.
(c) Supply Alternatives. Supplier and King shall meet within
[***] of such written notice pursuant to Section 2.6(b) to consider
alternative arrangements for meeting King's requirements for Products. Any
such alternative pursued shall be subject to all required regulatory
approvals and approval of both parties, which approval shall not be
unreasonably withheld. Any alternative arrangements entered into pursuant
to this Section 2.6(c) shall act in no way as a waiver of any other rights
or remedies which King or Supplier may have under this Agreement or
otherwise; provided, however, King shall have no obligation to pay for
orders of Products that Supplier is unable to provide.
(d) Capacity Allocation. In the event that Supplier's inability
to meet firm orders or forecasts is due to a shortage of production
capacity at Supplier's facility, in addition to the requirements of Section
2.6(a) and Section 2.6(b) above, Supplier shall promptly notify King of
such shortage of production capacity, and, if possible, the date such
shortage of production capacity is expected to end. In such event, Supplier
shall allocate its available production capacity to the production of
Products in such proportion (expressed as a function of equipment utilized)
as the production equipment capacity actually utilized to meet orders for
the Products over the previous [***] period bears to total production
equipment capacity in such Supplier facility(ies) over that same period.
(e) Supply Resumption. Supplier shall notify King as soon as
possible of the date upon which such shortage of production capacity will
cease. Upon resumption of production of Products, King shall resume
obtaining its requirements for
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
7
Products from Supplier to the extent such resumption is consistent with any
contractual arrangements entered into with third parties pursuant to
Section 2.6(c).
2.7. MANUFACTURING CHANGES. Subject to the procedures set forth in
Section 3.1(d) of the U.S. Product Agreement:
(a) Required Manufacturing Changes. For changes to the
Specifications or manufacturing processes that are required by Laws or by
medical or scientific concerns as to the toxicity, safety and/or efficacy
of the Products (collectively "Required Manufacturing Changes"), the
parties shall cooperate in making such changes promptly.
(b) Discretionary Manufacturing Changes. For changes to the
Specifications or Manufacturing process that are not Required Manufacturing
Changes (collectively "Discretionary Manufacturing Changes") the parties
must both agree to such Discretionary Manufacturing Changes and shall, to
the extent commercially reasonable under the circumstances, cooperate in
making such changes, and each party agrees that it shall not unreasonably
withhold its consent to such Discretionary Manufacturing Changes.
Notwithstanding the foregoing, Supplier's standard change control
procedures shall be utilized in reviewing such changes.
(c) Manufacturing Changes. Notwithstanding the foregoing, (i) all
costs associated with Required Manufacturing Changes, (including, without
limitation, obsolete raw materials, work-in-process and finished product
inventories, and excluding all printed materials, including without
limitation, packaging and labeling materials) shall be shared equally; (ii)
all costs associated with Required Manufacturing Changes regarding all
printed materials, including without limitation, packaging and labeling
materials shall be borne by King; and (iii) all costs associated with
Discretionary Manufacturing Changes shall be borne by the party initiating
such change. If any of the Required Manufacturing Changes (other than those
regarding printed materials) will result in aggregate costs in excess of
[***] (per Required Manufacturing Change event), then the parties agree
that either party may elect to be excused from its requirements under this
Agreement unless the other party agrees to bear the entire cost of such
Required Manufacturing Changes, and such an election shall be treated as an
early termination under Section 4.2 and subject to the requirements of
Section 4.4. An election by one (1) party to discontinue this Agreement in
accordance with the immediately preceding sentence shall apply only as to
the requirements of that electing party with respect to the particular
Product(s) precipitating such Required Manufacturing Changes. Furthermore,
if the aggregate costs of a Required Manufacturing Change with aggregate
costs in excess of [***] are paid for by King, then thereafter (i) King
shall have the right to terminate this Agreement pursuant to Section 4.1
upon [***] prior written notice to Supplier, and (ii) King shall own all
rights, title and interests in and to any assets purchased by Supplier for
such Required Manufacturing Change.
2.8. LABELING AND PACKAGING. Supplier shall ensure that all labeling
and packaging for the Products shall be consistent with the FDA or other
Governmental or Regulatory Authority approved labeling and packaging for the
Products.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
8
2.9. ANNUAL MINIMUM QUANTITIES.
(a) King shall purchase from Supplier a minimum quantity of [***]
of Product for each of 2006, 2007 and 2008 and, in the event that the Term
of this Agreement is extended to the Pediatric Extension Expiration Date,
pursuant to Section 4.1 of this Agreement, a minimum quantity of [***] of
Product for 2009 (the "Annual Minimum Quantity"). For the sake of clarity
it is agreed that the Annual Minimum Quantity for 2008 applies even if the
term of the Agreement expires prior to December 31, 2008.
King shall order the Annual Minimum Quantity in quarterly
installments of at least [***] of Product for each Calendar Quarter of each
year through 2008 and at least [***] of Product for the Calendar Year 2009
("Quarterly Minimum Quantity"). For the avoidance of doubt, the Annual
Minimum Quantities set forth in this Section 2.9(a) shall constitute the
aggregate of Product both in its powder and PC granules forms.
Additionally, the parties acknowledge that the Ramipril content of the
Product in PC granules form shall consist of approximately [***] of
Ramipril for each kilogram of Product.
(b) Subject to Section 2.9(e) below, the total payment made by
King to Supplier for each Calendar Quarter during the Term shall be [***]
(the "Minimum Quarterly Payment"). In the event that King does not order
and pay for at least the applicable Quarterly Minimum Quantity in any given
Calendar Quarter, then King shall pay [***].
(c) In the event that King does not pay the amount(s) described
in Section 2.9(b) pursuant to Section 3.2(a), Supplier in its sole
discretion may exercise the mechanism for default as set forth in Section
3.3.
(d) King shall have discretion to determine the schedule for
delivery of Product purchased and paid for by King in accordance with this
Agreement. For purposes of clarification, nothing in this Section 2.9(d)
shall modify or affect in any way King's obligation to place and pay for
orders of Product on a quarterly basis.
(e) In the event King's cumulative purchases of Product during
any Calendar Year meet the Annual Minimum Quantity, then King will no
longer be subject to the Annual Minimum Quantity (or the corresponding
Quarterly Minimum Quantity) or the Minimum Quarterly Payment for the rest
of that Calendar Year, and King may (i) cease orders of Product for the
rest of that Calendar Year, or (ii) order additional quantities of Product
during that Calendar Year, which additional quantities will be at the
Excess Price set forth in Section 3.1.
(f) In the event that any party other than Supplier, King or
Cobalt Pharmaceuticals, Inc. or its Affiliates (to the extent they are
selling a generic version of King's Altace(R) capsule product pursuant to
rights granted to them by King) (such other party being a "Third Party")
launches a generic formulation that contains Ramipril as its sole active
ingredient in the U.S. Territory (a "Generic Version"), the parties agree
that:
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
9
(i) King's obligations to purchase Product exclusively from
Supplier shall continue throughout the Term; and
(ii) King and Supplier shall negotiate in good faith to
determine the Annual Minimum Quantity, and the
corresponding Quarterly Minimum Quantity, for any
Calendar Year or Calendar Quarter that shall be
affected by such occurrence. Any such good faith
negotiation shall not include a reduction of the
Minimum Price or Excess Price, as set forth in Section
3.1 of this Agreement. In the event that the parties
are unable to reach agreement concerning a reduced
Annual Minimum Quantity, such dispute shall be subject
to the dispute resolution provisions of Section 10.1 of
this Agreement.
2.10. ANNUAL COMMITTED QUANTITIES.
(a) During the Term of this Agreement and only if required by
King, Supplier shall be obligated to supply to King the following
quantities of Product for each Calendar Year indicated below (the "Annual
Committed Quantity"):
Calendar Year Annual Committed Quantity
------------- -------------------------
2006 [***] metric tons
2007 [***] metric tons
2008 [***] metric tons
2009 [***] metric tons
The Annual Committed Quantity shall be the amount of Product reserved for
King each Calendar Year and shall be provided by Supplier to King in
accordance with the purchase order and forecast provisions of this
Agreement, including the Quarterly Minimum Quantity obligations. The
foregoing notwithstanding, in no event shall King be obligated or required
to purchase the Annual Committed Quantity in any given Calendar Year (other
than that portion consisting of the Annual Minimum Quantity).
(b) Supplier shall exert its reasonable best efforts to supply
King with quantities of Product required by King which exceed the Annual
Committed Quantity in any Calendar Year provided always that this Section
2.10(b) shall not be deemed to amend any rights of King or obligations of
Supplier under this Agreement, except that the parties agree that Section
2.6(d) of this Agreement shall not apply with regard to quantities
requested by King which exceed the Annual Committed Quantity. For
quantities that King requires which exceed the Annual Committed Quantity,
King is obligated to purchase such exceeding quantities from Supplier to
the extent Supplier is able to supply such exceeding quantities.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
10
ARTICLE III
PRODUCT PRICING AND PAYMENT
3.1. PRICING. The price for the Products constituting the Annual
Minimum Quantity shall be $[***] of Product (the "Minimum Price"). In the event
that King's orders exceed the Annual Minimum Quantity, the price shall be $[***]
of Product for the remaining orders in that Calendar Year (the "Excess Price").
The Minimum Price and the Excess Price shall remain firm during the Term.
3.2. PAYMENT.
(a) Terms. All payments required by this Agreement shall be made
in United States Dollars by wire transfer to an account designated by
Supplier. All invoices are strictly net and payment must be received within
[***] from the date of invoice. The date of each invoice shall be the date
of shipment of Products pursuant to Section 2.4. Payment shall be made
without deduction, deferment, set-off, lien or counterclaim of any nature,
other than for rejected or returned goods for which a credit acknowledgment
has been issued by Supplier. Time for payment shall be of the essence.
(b) Late Payments. Unless King notifies Supplier in writing of a
good faith dispute, with respect to payments not received within such
[***], interest shall accrue on any amount overdue, at the lesser of (i)
the prime rate as reported by the Xxxxxx Guaranty Bank and Trust, New York,
New York (the "Prime Rate") on the date such payment is due, plus an
additional [***] or (ii) the maximum rate permitted by law, such interest
to begin accruing on a daily basis from the date of invoice, and shall
accrue both before and after judgment; provided, however, in the case of a
good faith dispute regarding payment resolved to be due and not paid within
[***] after such resolution, such interest shall begin accruing on a daily
basis from the date such payment becomes overdue, and shall accrue [***];
provided, further, in the case of a good faith dispute regarding payment,
King may in its discretion determine to pay such amounts disputed to be
overdue and in the event amounts are finally determined not to be due by
King, Supplier shall repay such excess amounts to King determined not be
due, and interest shall accrue on any such amount, at the lesser of (i)
Prime Rate plus an additional [***] or (ii) the maximum rate permitted by
law, such interest to begin accruing on a daily basis from the date such
disputed payment was received by Supplier.
(c) Default. In the event that King fails to make its payments
consistent with the terms in Sections 2.9(b) or 3.2(a), then Supplier shall
give to King a notice of default, and King shall have thirty (30) days to
cure the default. If King has not cured such default within the [***]
period, then Supplier shall, in its sole discretion, and without prejudice
to any other of its accrued rights, be entitled to liquidated damages as
set forth in Section 3.3; provided, however, a good xxxxx xxxx fide dispute
by King regarding a payment pursuant to this Agreement shall not be
considered a default of payment so long as King notifies Supplier in
writing of such dispute within the later of [***] from the date of invoice
or the date of payment. King acknowledges it will notify Supplier promptly
upon a determination that a dispute exists regarding a payment.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
11
(d) Resolution of Payment Disputes. Unless the parties otherwise
agree, if the parties are unable to resolve any payment dispute within the
[***] period after receipt by Supplier of written notice from King of a
dispute regarding payment, the New York office of the certified public
accounting firm of Xxxxxx Xxxxxxxx, XX (the "Arbitrating Accountant") shall
be engaged as arbitrator hereunder to settle such dispute as soon as
practicable. In the event Xxxxxx Xxxxxxxx, XX is unwilling or unable to
serve as the Arbitrating Accountant, the parties hereto shall select by
mutual agreement another nationally-recognized independent certified public
accounting firm, who is not rendering (and during the preceding two-year
period has not rendered) services to either Supplier, King, or any of their
respective Affiliates, to serve as the Arbitrating Accountant. In
connection with the resolution of any dispute, the Arbitrating Accountant
shall have access to all documents, records, work papers, facilities and
personnel necessary to perform its function as arbitrator. The arbitration
before the Arbitrating Accountant shall be conducted in accordance with the
Commercial Arbitration Rules of the American Arbitration Association. The
Arbitrating Accountant's award with respect to any dispute shall be final
and binding upon the parties hereto, and judgment may be entered on the
award. The party against whom an award is made shall pay fees and expenses
of the Arbitrating Accountant with respect to any dispute; provided,
however, if there is no award made or an award is made for or against both
parties, [***] the fees and expenses of the Arbitrating Accountant.
3.3. LIQUIDATED DAMAGES. In the event that King does not comply with
its requirements under Section 2.9(b), then Supplier in its sole discretion
shall be entitled to the following as liquidated damages:
(a) Until such time as a Third Party has launched a Generic
Version, a payment in an amount equal to (i) [***] if King had purchased
its Annual Minimum Quantity requirements of Product at the Minimum Price
[***] (ii) an amount equal to [***] as of the date of default through the
expiration of the Term based on its Annual Minimum Quantity requirements;
or
(b) In the event that a Third Party has launched a Generic
Version and Supplier and King have mutually agreed to a modified Annual
Minimum Quantity to be purchased by King pursuant to Section 2.9(f), a
payment in an amount equal to (i) [***] if King had purchased its modified
Annual Minimum Quantity of Product at the Minimum Price through the
expiration of the Term minus (ii) [***] as of the date of default through
the expiration of the Term based on the modified Annual Minimum Quantity
requirements.
3.4. ADVERTISING/MARKETING/SALES COSTS AND PRODUCT PRICING. King shall
be responsible for all advertising, marketing and sales costs associated with
Licensed Product distribution. King shall have complete authority for all sales
pricing decisions for the Licensed Products.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
12
ARTICLE IV
TERM AND TERMINATION
4.1. TERM. Unless terminated earlier in accordance with the provisions
of Section 4.2 herein, the term of this Agreement (the "Term") will commence
upon execution of this Agreement and continue through October 29, 2008; provided
that the Term automatically will be extended until the Pediatric Extension
Expiration Date in the event any Pediatric Extension is granted to King.
4.2. EARLY TERMINATION. Either King or Supplier, as the case may be,
may terminate this Agreement forthwith by notice in writing to the other party
upon the occurrence of any of the following events:
(a) if the other party commits a material breach of this
Agreement, which in the case of a breach capable of remedy shall not have
been remedied within thirty (30) days of the receipt by the other party of
a notice identifying the breach and requiring its remedy or such longer
time as the party in breach may demonstrate to the other party is necessary
to remedy the breach using its reasonable efforts to do so; or
(b) if the other party ceases for any reason to carry on business
(but not as the result of a merger, acquisition or reorganization with one
or more entities whether in a single transaction or a series of
transactions) or convenes a meeting of its creditors or has a receiver or
manager appointed in respect of all or substantially all of its assets or
is the subject of an application for an administration order or of any
proposal for a voluntary arrangement or enters into liquidation (whether
compulsorily or voluntarily) or undergoes any analogous act or proceedings
under foreign law; or
(c) the enactment of any law, order or regulation by a
governmental unit that would render it impossible for the other party to
perform its obligations hereunder.
4.3. CONSEQUENCES OF TERMINATION AND SURVIVAL. Termination of this
Agreement for whatever reason shall not affect the accrued rights and
obligations of either Supplier or King arising under or out of this Agreement.
The obligations under Article VI (Product Recalls), Article VII (Warranties),
Article VIII (Nondisclosure and Confidentiality), Article IX (Indemnification
and Insurance), Article X (Dispute Resolution) or any other provision which
expressly or by implication is intended to survive expiration or termination
shall survive expiration or termination of this Agreement.
4.4. ACCRUED OBLIGATIONS. At the end of the Term, and in the event
that this Agreement is terminated by Supplier pursuant to the provisions of
Section 4.2, King shall in each case pay to Supplier: (i) all amounts
outstanding and remaining to be paid for Products supplied prior to the end of
the applicable term or termination; (ii) all binding amounts for Products
forecasted pursuant to Section 2.2 herein or ordered pursuant to Section 2.3
herein prior to the end of the applicable term or termination; provided,
Supplier delivers such orders in accordance with the Specifications; and (iii)
an amount to compensate Supplier at its actual out-of-pocket costs for all raw
materials that Supplier has reasonably purchased in reliance on King's forecasts
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
13
or is contractually committed to purchase at the time of such end of the
applicable term or termination pursuant to authorization received from King in
accordance with Section 2.3(b) herein which is not subsequently used by Supplier
to manufacture any Product or any other product.
ARTICLE V
CERTIFICATES AND ACCESS AND REGULATORY MATTERS
5.1. CERTIFICATES OF ANALYSIS. Supplier shall perform, or cause to be
performed, sample tests on each lot of Product manufactured pursuant to this
Agreement before delivery to King. Each test report shall set forth the items
tested, Specifications and test results in a certificate of analysis, containing
the types of information which shall have been approved by mutual agreement of
the parties, for each lot delivered. Supplier shall send, or cause to be sent,
such certificates to King simultaneously with delivery of each lot unless
otherwise agreed. Supplier shall provide King with [***] per year.
5.2. NOTICE OF FAILURE TO MEET SPECIFICATIONS. Upon Supplier's
discovery that any batch or lot of Product, which has previously been approved
by Supplier, fails to conform to the Specifications, Supplier will immediately
notify King of such failure to meet the Specifications and of the nature thereof
in detail, including, but not limited to, supplying King with all investigatory
reports, data, and communications, out-of-specification reports and data and the
results of all outside laboratory testing and conclusions, if any. Supplier
shall investigate all such failures promptly, and [***], cooperate with King in
determining the cause for the failure and a corrective action to prevent future
failures.
5.3. STABILITY. At Supplier's expense, Supplier shall be responsible
for taking quality control stability samples of the Product in support of the
NDAs for the Licensed Products, testing stability samples on a timely basis, and
providing King with all reports and data generated therefrom. Upon learning of a
stability test failure, Supplier shall immediately notify King and immediately
initiate a stability failure investigation [***] and cooperate with King in
determining the cause for the failure and corrective action to prevent future
failures. For Product manufactured by Supplier prior to the date of this
Agreement, Supplier shall, [***], maintain its current stability test program
and protocols and report the results to King.
5.4. DMFS. Upon King's written request, Supplier shall promptly send a
letter in form and substance satisfactory to King to each of Supplier's
suppliers that are referenced in the NDA with respect to the Products requesting
permission for King to reference such supplier's DMFs, in order to notify such
supplier of the transfer of the Products from Supplier to King (pursuant to the
General Products Agreement and the Operative Agreements (as such term is defined
in the General Products Agreement)) and to obtain appropriate Drug Master File
reference authorizations from such supplier.
5.5. RECORDS. Supplier shall maintain all manufacturing, packaging,
analytical and stability records, all records of shipment, and all validation
data relating to the Product to the extent and for the time periods required by
applicable Laws with respect to the Products.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
14
5.6. REGULATORY COMPLIANCE. Supplier shall advise King promptly if an
authorized agent of the FDA or other Governmental or Regulatory Authority visits
any of Supplier's manufacturing facilities, or the facilities where the Products
are being manufactured, concerning the Products. Supplier shall furnish to King
all material information supplied to, or supplied by, the FDA or other
governmental regulatory agency, including the Form 483 observations and
responses, to the extent that such report relates to Products (or the ability of
Supplier to supply such Products), within [***] of Supplier's receipt of such
information or delivery of such information, as the case may be. Supplier's
response to the Form 483 is subject to the requirements of Sections 2.7 and 5.7
of this Agreement.
5.7. CHANGES. In addition to the requirements of Section 2.7 herein,
Supplier shall not change the critical specified raw materials, packaging
materials, their source, analytical test procedures or critical manufacturing
conditions or manufacturing equipment used in the manufacture of Product without
the prior written consent of King, which consent shall not be unreasonably
withheld.
5.8. ACCESS TO FACILITIES.
(a) King Access. Upon the reasonable prior written request of
King, King shall have the right to inspect those portions of the
manufacturing, storage, packaging and testing facilities of Supplier where
Products are being manufactured, stored, packaged or tested, as the case
may be, during regular business hours, to ascertain compliance with cGMPs,
the Specifications and the regulatory application associated with the
Product. If the FDA or other applicable Governmental or Regulatory
Authority asserts any notice to the effect that Supplier has failed to
comply with any law or regulation in connection with the manufacture of
Products, or if Supplier delivers Product that does not meet the
Specifications, then King shall have the right to inspect such portions of
the manufacturing facilities of Supplier that relate to the manufacture of
Product upon reasonable notice and during normal business hours.
Notwithstanding the provisions of this Section 5.8(a), King shall have no
obligation or be deemed to have an obligation to inspect the manufacturing
and testing facilities of Supplier.
(b) Supplier Access. Upon the reasonable prior written request of
Supplier, Supplier shall have the right based upon demonstrable cause to
inspect those portions of the warehouse and distribution facilities of King
where Products are being stored and distributed, during regular business
hours, to observe Product storage and distribution or other related
activities. Notwithstanding the provisions of this Section 5.8(b), Supplier
shall have no obligation or be deemed to have an obligation to inspect the
warehouse and distribution facilities of King.
5.9. REGULATORY CORRESPONDENCE. Within [***] of receipt, King and
Supplier shall make available, or cause to be made available, to each other,
regulatory correspondence regarding regulatory letters, withdrawal of Product,
and correspondence bearing on the safety and efficacy of the Product.
5.10. LICENSED PRODUCT INQUIRIES AND COMPLAINTS. King will promptly
submit to Supplier all Licensed Product safety and efficacy inquiries, Licensed
Product quality
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
15
complaints and adverse drug event reports received by it, together with all
available evidence and other information relating thereto, in accordance with
procedures to be agreed upon by the parties. Except as otherwise required by law
or governmental regulation, King will be responsible for investigating and
responding to all such inquiries, complaints and adverse events regarding
Licensed Product. It shall be the responsibility of King to comply with all
federal, state and local governmental reporting requirements regarding adverse
drug events and Licensed Product quality matters, except where such events or
matters are caused by acts or omissions of Supplier, in which case King may,
consistent with applicable law and regulation, request Supplier's assistance in
such compliance. In addition to the foregoing, King will forward a copy of all
FDA submissions concerning Licensed Product adverse drug events or any Licensed
Product safety-related topic to Supplier within [***] of submission.
5.11. RESPONSE TO COMPLAINTS AND/OR ADVERSE DRUG EVENTS. Pursuant to
reported complaint and/or adverse drug event, if the nature of the reported
complaint and/or adverse drug event requires testing, Supplier will, at King's
reasonable request and expense, perform analytical testing of corresponding
retention samples and provide the results thereto to King as soon as reasonably
practicable; provided, however, Supplier shall be responsible for [***] costs of
such testing and reporting to the FDA or any other governmental regulatory
agency if it is determined that Supplier is responsible for such reported
complaint and/or adverse drug event. Such testing shall be performed using NDA
approved testing procedures as set forth in the NDA.
5.12. ADDITIONAL INFORMATION. Supplier shall provide to King in a
timely manner, but in no event less than [***] prior to the due date of King's
annual report to the FDA with respect to the Products, all information (in
written form) which King requests regarding the Products in order to comply with
applicable Laws. King shall be responsible for assuring that all promotional
material produced by it relating to Licensed Products comply with applicable
Laws. King shall provide to Supplier a copy of such FDA annual report. Such
information shall include, without limitation, manufacturing and testing
documentation.
5.13. TECHNICAL AGREEMENT. Each party shall perform the duties
required of it pursuant to the Technical Agreement to be entered into by the
parties in the form of EXHIBIT D. To the extent the Technical Agreement either
conflicts with this Agreement or is silent on an issue addressed herein, this
Agreement shall control.
ARTICLE VI
PRODUCT RECALLS
6.1. PRODUCT RECALLS. In the event (i) any Government or Regulatory
Authority issues a request, directive or order that Product be recalled, (ii) a
court of competent jurisdiction orders such a recall, or (iii) Supplier shall
reasonably determine that Product should be recalled, the parties shall take all
appropriate corrective actions, and shall cooperate in the investigations
surrounding the recall. In the event Supplier determines that Product should be
recalled, Supplier shall consult with King prior to taking any corrective
actions. Supplier shall be responsible for all expenses of such recall which
shall include the expenses of notification and destruction or return of the
recalled Product and all other documented out-of-pocket costs incurred in
connection with such recall, but shall not include lost profits of either party.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
16
Notwithstanding the foregoing Supplier shall not be responsible for the costs of
any recall resulting from King's improper use, handling or storage of Product.
6.2. DISPUTES. If there is any dispute concerning which party's acts
or omissions gave rise to such recall of Product, such dispute shall be referred
for decision to an independent expert (acting as an expert and not as an
arbitrator) to be appointed by agreement between King and Supplier or, in the
absence of agreement, by the President for the time being of the Pharmaceutical
Research and Manufacturers of America. The decision of such independent expert
shall be in writing and, except for manifest error on the face of the decision,
shall be binding on both King and Supplier. The costs of such independent expert
shall be borne [***]. After such determination, costs shall be paid by the
responsible party in accordance with Section 6.1.
ARTICLE VII
WARRANTIES
7.1. COMPLIANCE WITH CGMP. Supplier warrants that all Products will be
manufactured in conformity with the regulations of the FDA and any comparable
state agency applicable thereto.
7.2. CONFORMITY WITH SPECIFICATIONS. Supplier warrants that each
Product manufactured by Supplier and sold to King pursuant to this Agreement
will meet the Specifications for such Product in effect at the time title to
such Product passes from Supplier to King pursuant to Section 2.4. King may
amend such Specifications from time to time only with the prior written consent
of Supplier, which consent shall not be unreasonably withheld.
7.3. COMPLIANCE WITH THE ACT. Supplier warrants that all Product
delivered to King pursuant to this Agreement will, at the time of such delivery,
not be adulterated within the meaning of the Act and will not be an article
which may not, under the provisions of such Act, be introduced into interstate
commerce.
7.4. NO LIENS. Supplier warrants that all Product delivered to King
pursuant to this Agreement will, at the time of such delivery, be free and clear
of all liens, encumbrances, security interests and other encumbrances.
7.5. COMPLIANCE WITH APPLICABLE LAWS. During the term of this
Agreement, Supplier shall comply in all material respects with all Laws
applicable to the conduct of its business in the performance of this Agreement.
7.6. EXCLUSION OF OTHER WARRANTIES. EXCEPT WHERE OTHERWISE SET FORTH
IN THIS AGREEMENT, SECTIONS 7.1, 7.2, 7.3, 7.4 AND 7.5 ARE IN LIEU OF ALL
CONDITIONS, WARRANTIES AND STATEMENTS IN RESPECT OF PRODUCT AND IN RESPECT OF
THE MANUFACTURING SERVICES PROVIDED HEREUNDER, WHETHER EXPRESSED OR IMPLIED BY
STATUTE, CUSTOM OF THE TRADE OR OTHERWISE (INCLUDING BUT WITHOUT LIMITATION ANY
SUCH CONDITION, WARRANTY OR STATEMENT RELATING TO THE DESCRIPTION OR QUALITY OF
PRODUCT, ITS MERCHANTABILITY OR ITS FITNESS FOR A PARTICULAR PURPOSE OR USE
UNDER ANY CONDITIONS) AND ANY SUCH CONDITION, WARRANTY OR
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
17
STATEMENT IS HEREBY EXCLUDED. EXCEPT AS PROVIDED IN ARTICLE IX HEREIN,
REPLACEMENT OF ANY NONCONFORMING PRODUCT AND REASONABLE DOCUMENTED OUT-OF-POCKET
EXPENSES SHALL BE KING'S SOLE REMEDY FOR BREACH OF ANY EXPRESS WARRANTY
CONTAINED IN THIS ARTICLE VII. In no event shall Supplier or King be liable
under or with respect to this Agreement for any indirect, incidental,
consequential, special or punitive damages of any kind, including, but not
limited to, loss of profits, including, but not limited to, due to breach of
warranty, tort, breach or repudiation of any term or condition of this
Agreement.
ARTICLE VIII
NONDISCLOSURE AND CONFIDENTIALITY
8.1. NONDISCLOSURE OBLIGATIONS.
(a) Except as otherwise provided in this Agreement, Supplier
acknowledges that the know-how with which it may be supplied pursuant to
this Agreement is supplied in circumstances imparting an obligation of
confidence and agrees to keep such know-how secret and confidential and to
respect King's proprietary rights therein and to use the same for the sole
purpose of this Agreement and during the period of this Agreement or at any
time for any reason whatsoever not to disclose or cause or permit to be
disclosed such know-how to any third party.
(b) Supplier shall ensure that only its employees or employees of
its Affiliates or consultants and contractors shall have access to know-how
on a need to know basis and shall be subject to the same obligations of
confidence as the principals pursuant to Section 8.1(a) above and shall
enter into secrecy agreements in support of such obligations. Insofar as
this is not reasonably practicable, Supplier shall take all reasonable
steps to ensure that any such employees, consultants and contractors are
made aware of such obligations.
(c) Both parties undertake and agree not to disclose or permit to
be disclosed at any time for any reason whatsoever to any third party or
otherwise make use of or permit to be made use of any trade secrets or
confidential information relating to the technology, business affairs or
finances of the other or of any Affiliates, suppliers, agents,
distributors, licensees, licensors or other customers of the other which
comes into their possession pursuant to this Agreement.
(d) The obligations of confidence referred to in this Section 8.1
shall not extend to any information which:
(i) is or becomes part of the public domain other than by
unauthorized acts of the party obligated not to disclose such
information or its Affiliates or sublicensees, as applicable;
(ii) can be shown by written documents to have been
disclosed to the receiving party or its Affiliates or sublicensees by
a third party, provided such information was not obtained by such
third party directly or indirectly from the other party under this
Agreement pursuant to a confidentiality agreement;
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
18
(iii) prior to disclosure under this Agreement, was already
in the possession of the receiving party or its Affiliates or
sublicensees, provided such information was not obtained directly or
indirectly from the other party under this Agreement pursuant to a
confidentiality agreement;
(iv) can be shown by written documents to have been
independently developed by the receiving party or its Affiliates
without breach of any of the provisions of this Agreement;
(v) is disclosed by the receiving party pursuant to oral
questions, interrogatories, requests for information or documents,
subpoena, or a civil investigative demand of a court or governmental
agency; provided, however, that the receiving party notifies the other
party immediately upon receipt thereof so that the other may seek a
protective order or other appropriate remedy, and provided further
that the disclosing party furnishes only that portion of the
information which it is advised by counsel is legally required and
impose such obligations of secrecy as are possible in that regard; or
(vi) is required to be disclosed by a party under any
statutory, regulatory or similar legislative requirement or any rule
of any stock exchange to which it or any Affiliate is subject;
provided, however, that the non-disclosing party shall be allowed to
review the proposed disclosure and the disclosing party agrees to
consider in good faith any proposed revisions thereof provided to the
disclosing party within [***] of the non-disclosing party's receipt of
the proposed disclosure, and the parties shall seek confidential
treatment for such disclosure as permitted by applicable law.
8.2. TERMS OF THIS AGREEMENT. The parties agree not to disclose any
terms or conditions of this Agreement to any third party without the prior
consent of the other parties, except as required by applicable Laws.
8.3. INJUNCTIVE RELIEF. The parties hereto understand and agree that
remedies at law may be inadequate to protect against any breach of any of the
provisions of this Article VIII by either party or their employees, agents,
officers or directors or any other person acting in concert with it or on its
behalf. Accordingly, each party shall be entitled to the granting of injunctive
relief by a court of competent jurisdiction against any action that constitutes
any such breach of this Article VIII.
ARTICLE IX
LIMITATION OF LIABILITY, INDEMNIFICATION AND INSURANCE
9.1. INDEMNIFICATION BY KING. Except as otherwise specifically
provided herein, King shall indemnify and maintain Supplier against all claims,
actions, costs, expenses (including court costs and legal fees on a full
indemnity basis) or other liabilities ("Liabilities") whatsoever in respect of:
(a) any negligence or willful misconduct by King in relation to
the use, marketing, storage, distribution, handling or sale of Product;
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
19
(b) any labeling of any Product to the extent that such labeling
has been supplied by or at the direction of King and applied in accordance
with instructions from King; and
(c) any representation or warranty made by King to its customers
or users with respect to Product, other than representations or warranties
contained in Sections 7.1, 7.2, 7.3, 7.4 or 7.5.
9.2. INDEMNIFICATION BY SUPPLIER. Except as otherwise specifically
provided herein, Supplier shall indemnify and maintain King against all
Liabilities whatsoever in respect of:
(a) Supplier's failure to comply with the Specifications, cGMP,
or applicable Laws;
(b) any breach of a representation or warranty made by Supplier
in Article VII; and
(c) any negligence or willful misconduct by Supplier in the
manufacture, storage, packaging, testing, labeling, handling or shipping of
Product.
9.3. INDEMNIFICATION PROCEDURES. A party (the "Indemnitee") that
intends to claim indemnification under this Article IX shall:
(a) notify the other party (the "Indemnitor") of any Liability
with respect to which the Indemnitee intends to claim indemnification as
soon as practicable after the Indemnitee becomes aware of any such
Liability;
(b) permit the Indemnitor to assume the defense thereof with
counsel mutually satisfactory to the parties; and
(c) cooperate with the Indemnitor, at the Indemnitor's expense,
in the defense thereof.
With respect to any matter for which the Indemnitor has an obligation
to indemnify the Indemnitee under this Agreement, the Indemnitee shall have the
right to participate and be represented (at the Indemnitor's expense) by legal
counsel of the Indemnitee's choice in all proceedings and negotiations, if
representation by counsel retained by Indemnitor would be inappropriate due to
actual or potential differing interests between the Indemnitee and any other
party represented by such counsel in such proceedings. The indemnity agreement
in this Article IX shall not apply to amounts paid in settlement of any
Liability if such settlement is effected without the consent of the Indemnitor,
which consent shall not be unreasonably withheld. Failure of the Indemnitee to
deliver notice to the Indemnitor within a reasonable time after becoming aware
of a Liability shall not relieve the Indemnitor of any liability to the
Indemnitee pursuant to this Article IX, except to the extent such delay
prejudices the Indemnitor's ability to defend such action.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
20
9.4. DISTRIBUTION/ PRODUCT LIABILITY INSURANCE. King shall obtain and
maintain in effect for the Term of this Agreement, liability insurance or
indemnity policies with an insurer reasonably acceptable to Supplier, in an
amount not less than [***] (in the aggregate) with an indemnity to principals
clause with respect to products liability and distribution, which policies shall
name Supplier as an additional insured and shall be blanket policies. Such
policies shall insure against liability on the part of King and any of its
Affiliates, as their interests may appear, due to injury, disability or death of
any person or persons, or injury to property, arising from the distribution of
Products. Upon the execution of this Agreement and thereafter on January 1 of
each year during the Term, King shall provide to Supplier a certificate of
insurance (i) summarizing the insurance coverage and (ii) identifying any
exclusions. King shall promptly notify Supplier of any material adverse
alterations to the terms of this policy or decreases in the amounts for which
insurance is provided.
9.5. PRODUCT LIABILITY CLAIMS. As soon as it becomes aware, each party
will give the other prompt written notice of any defect or alleged defect in a
Product, any injury alleged to have occurred as a result of the use or
application of a Product, and any circumstances that may give rise to litigation
or recall of a Product or regulatory action that may affect the sale or
manufacture of a Product, specifying, to the extent the party has such
information, the time, place and circumstances thereof and the names and
addresses of the persons involved. Each party will also furnish promptly to the
other copies of all papers received in respect of any claim, action or suit
arising out of such alleged defect, injury or regulatory action.
ARTICLE X
DISPUTE RESOLUTION
10.1. DISPUTE RESOLUTION.
(a) Any dispute, controversy or claim arising out of or relating
to this Agreement, or the breach, termination, or invalidity of this
Agreement, except as set forth in Section 10.2, shall be submitted in the
first instance to the Chief Operating Officer of Supplier, or such person's
designee of equivalent or superior position, and the Chief Operating
Officer of King, or such person's designee of equivalent or superior
position.
(b) If the matter or dispute cannot be resolved by the
individuals designated in Section 10.1(a) within [***] after such
submission, it shall be settled by arbitration in accordance with the
Commercial Arbitration Rules of the American Arbitration Association,
except as modified by this Section. The number of arbitrators shall be
three (3), [***]. The arbitration proceeding shall be conducted in the
English language. The arbitration proceeding shall be brought in New York,
New York, unless the parties agree in writing to conduct the arbitration in
another location.
(c) The arbitration decision shall be binding and not be
appealable to any court in any jurisdiction. The prevailing party may enter
such decision in any court having competent jurisdiction.
(d) Each party shall pay its own expenses of arbitration and the
expenses of the arbitrators shall be equally shared except that if, in the
opinion of the
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
21
arbitrators, any claim by a party hereto or any defense or objection
thereto by the other party was unreasonable, the arbitrators may in their
discretion assess as part of the award any part of the arbitration expenses
of the other party (including reasonable attorneys' fees) and expenses of
the arbitrators against the party raising such unreasonable claim, defense
or objection.
(e) Any party may, without inconsistency with this Agreement,
apply to any court having jurisdiction hereof and seek injunctive relief so
as to maintain the status quo until such time as the arbitration award is
rendered or the controversy is otherwise resolved.
10.2. NON-ARBITRABLE ISSUES. The parties acknowledge that matters
relating to Specifications as set forth in Section 2.5(a), payments as set forth
in Section 3.2(a), (b) or (c), or product recalls as set forth in Section 6.1
shall not be submitted to arbitration pursuant to Section 10.1 hereof, but
instead shall be resolved in accordance with Section 2.5(b), 3.2(d) and 6.2,
respectively.
ARTICLE XI
GENERAL PROVISIONS
11.1. NOTICES.
(a) Except as otherwise specifically provided herein, any notice
or other documents to be given under this Agreement shall be in writing and
shall be deemed to have been duly given if sent by registered post,
nationally recognized overnight courier or facsimile transmission to a
party or delivered in person to a party at the address or facsimile number
set out below for such party or such other address as the party may from
time to time designate by written notice to the other:
If to King, to:
King Pharmaceuticals, Inc.
000 Xxxxx Xxxxxx
Xxxxxxx, Xxxxxxxxx 00000
Attn: Chairman of the Board
Facsimile: 000-000-0000
with copies to:
King Pharmaceuticals, Inc.
000 Xxxxx Xxxxxx
Xxxxxxx, Xxxxxxxxx 00000
Attn: Executive Vice President and General Counsel
Facsimile: 000-000-0000
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
22
and
Monarch Pharmaceuticals, Inc.
000 Xxxxxxx Xxxxxx
Xxxxxxx, XX 00000
Attn: Chief Executive Officer
Facsimile: 000-000-0000
If to Supplier to:
Sanofi-Aventis Deutschland GmbH
Attn: Legal Department
Xxxxxxxxxxxxxxx 00
00000 Xxxxxxxxx
Xxxxxxx
Fax: Legal Department No.: xx 00 00 000 00000
with copies to:
Sanofi-Aventis Deutschland GmbH
Attn: Head of PharmaChemical Sales
IndustriePark Xxxxxxx
Xxxxxxx / Xxxxxxxx X 000
00000 Xxxxxxxxx xx Xxxx
Fax: xx 00 00 00 00 00
and
Sanofi-Aventis
000 Xxxxxx xx Xxxxxx
00000 Xxxxx Xxxxxx
Attn: Head of Direction Juridique
Facsimile: x00-00-00-00-00-00
(b) Any such notice or other document shall be deemed to have
been received by the addressee [***] following the date of dispatch of the
notice or other document by post or, where the notice or other document is
sent by overnight courier, by hand or is given by facsimile, simultaneously
with the transmission or delivery. To prove the giving of a notice or other
document it shall be sufficient to show that it was dispatched.
11.2. ENTIRE AGREEMENT; AMENDMENT.
(a) This Agreement, together with the General Products Agreement
and the other Operative Agreements (as such term is defined in the General
Products Agreement) and the Exhibits and Schedules attached hereto and
thereto, embodies and sets forth the entire agreement and understanding of
the parties with respect to the subject
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
23
matter herein and there are no promises, terms, conditions or obligations,
oral or written, expressed or implied, other than those contained in this
Agreement. The terms of this Agreement shall supersede all previous oral or
written agreements which may exist or have existed between the parties
relating to the subject matter of this Agreement, including without
limitation the Original Agreement. No party shall be entitled to rely on
any agreement, understanding or arrangement which is not expressly set
forth in this Agreement. Any other terms and conditions (including without
limitation any terms and conditions contained in any purchase order or
sales invoice issued pursuant to this Agreement) are hereby expressly
excluded.
(b) This Agreement shall not be amended, modified, varied or
supplemented except in writing signed by duly authorized representatives of
the parties.
11.3. FORCE MAJEURE. If a party is prevented or delayed in the
performance of any of its obligations under this Agreement by Force Majeure (as
defined herein) and shall give written notice thereof to the other parties
specifying the matters constituting Force Majeure together with such evidence as
such party reasonably can give and specifying the period for which it is
estimated that such prevention or delay will continue, the party shall be
excused from the performance or the punctual performance of such obligations as
the case may be from the date of such notice for so long as such cause of
prevention or delay shall continue. The expression "Force Majeure" shall be
deemed to include any cause substantially affecting the performance by a party
of this Agreement arising from or attributable to acts, events, non-happenings,
omissions or accidents beyond the reasonable control of the party whose
performance is so affected.
11.4. ASSIGNMENT. No party shall be entitled to assign its rights and
obligations hereunder without the prior written consent of the other parties;
provided, however, a party shall be entitled, without the prior written consent
of the other parties, to assign its rights and obligations hereunder to an
Affiliate, but such assignment to an Affiliate shall not relieve the assigning
party of its obligations hereunder. No permitted assignment hereunder shall be
deemed effective until the assignee shall have executed and delivered an
instrument in writing reasonably satisfactory in form and substance to the other
parties pursuant to which the assignee assumes all of the obligations of the
assigning party hereunder. Any purported assignment of this Agreement in
violation of this Section 11.4 shall be void. This Agreement shall be binding
upon the successors and permitted assigns of the parties and the name of a party
appearing herein shall be deemed to include the names of its successors and
assigns. Notwithstanding the foregoing provisions of this Section 11.4, King's
rights hereunder may be assigned as security to one or more financial
institutions providing financing to King and may be assigned pursuant to the
terms of the relevant security agreement, it being understood that no such
assignment shall release King from any of its obligations hereunder (or be
deemed to constitute an assumption by such an assignee of such obligations) or
increase or otherwise modify the obligations of Supplier hereunder.
11.5. HEADINGS, INTERPRETATION. The headings used in this Agreement
are for convenience only and are not a part of this Agreement nor affect the
interpretation of any of its provisions.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
24
11.6. ATTACHMENTS. All Exhibits and Schedules referenced herein are
hereby made a part of this Agreement.
11.7. INDEPENDENT PARTIES. This Agreement shall not be deemed to
create any partnership, joint venture, amalgamation or agency relationship
between the parties. Each party shall act hereunder as an independent
contractor.
11.8. GOVERNING LAW. This Agreement shall be governed by and construed
under the laws of the State of Missouri, without giving effect to the choice of
law provisions thereof.
11.9. NO WAIVER. Neither the failure nor delay on the part of a party
to require the strict performance of any term, covenant or condition of this
Agreement or to exercise any right or remedy available on a breach thereof shall
constitute a waiver of any such breach or of any such term or condition. The
consent to, or the waiver of, any breach, or the failure to require on any
single occasion the performance or timely performance of any term, covenant, or
condition of this Agreement shall not be construed as authorizing any subsequent
or additional breach and shall not prevent a subsequent enforcement of such
term, covenant, or condition.
11.10. SEVERABILITY. In the event that any provision of this Agreement
or the application thereof to any party or circumstance shall be finally
determined by a court of proper jurisdiction to be invalid or unenforceable to
any extent, then (i) a suitable and equitable provision shall be substituted
therefore in order to carry out, so far as may be valid and enforceable, the
intent and purpose of such invalid and unenforceable provision and (ii) the
remainder of this Agreement and the application of such provision to the parties
or circumstances other than those to which it is held invalid or unenforceable
shall not be affected thereby.
11.11. INTERPRETATION. The parties hereto acknowledge and agree that:
(i) each party and its representatives has reviewed and negotiated the terms and
provisions of this Agreement and have contributed to its revision; (ii) the rule
of construction to the effect that any ambiguities are resolved against the
drafting party shall not be employed in the interpretation of this Agreement;
and (iii) the terms and provisions of this Agreement shall be construed fairly
as to each party hereto and not in favor of or against either party regardless
of which party was generally responsible for the preparation of this Agreement.
11.12. COUNTERPARTS. This Agreement may be executed simultaneously in
two or more counterparts, each of which shall be deemed an original, but both of
which together shall constitute a single agreement.
11.13. THIRD PARTY BENEFICIARIES. This Agreement is not intended to
confer upon any non-party rights or remedies hereunder, except as may be
received or created as part of a valid assignment.
11.14. FURTHER ASSURANCES. Each party shall execute and deliver such
additional instruments and other documents and use all commercially reasonable
efforts to take or cause to be taken, all actions and to do, or cause to be
done, all things necessary under applicable law to consummate the transactions
contemplated hereby.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
25
[Remainder of page intentionally left blank]
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
26
IN WITNESS WHEREOF, the parties hereto have each caused this Amended
And Restated U.S. Product Manufacturing Agreement to be duly executed as of the
date first above written.
SANOFI-AVENTIS DEUTSCHLAND GMBH
By:
------------------------------------
Name:
----------------------------------
Title:
---------------------------------
SANOFI-AVENTIS DEUTSCHLAND GMBH
By:
------------------------------------
Name:
----------------------------------
Title:
---------------------------------
KING PHARMACEUTICALS, INC.
By:
------------------------------------
Name:
----------------------------------
Title:
---------------------------------
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
SCHEDULE 1.30
SPECIFICATIONS FOR PRODUCT
POWDER
The Specifications are as set forth in the attached Certificate of Analysis of a
representative sample.
GRANULES
The Specifications are as set forth in the attached Certificate of Analysis of a
representative sample.
CONFIDENTIAL TREATMENT REQUESTED
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
SCHEDULE 1.31
CHEMICAL FORMULA OF RAMIPRIL
(CHEMICAL FORMULA OF RAMIPRIL)
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
EXHIBIT B
QUANTITIES/CAPACITY
Quantities
[***]
[***]
Capacity
Calendar Year Technical Capacity
------------- ------------------
2006 [***] of Product
2007 [***] of Product
2008 [***] of Product
2009 [***] of Product
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
EXHIBIT D
TECHNICAL AGREEMENT
December 17, 1998
PURSUANT TO THE TERMS OF THE U.S. PRODUCT MANUFACTURING AGREEMENT BY AND BETWEEN
KING PHARMACEUTICALS, INC. ("KING") AND HOECHST XXXXXX XXXXXXX, INC. ("HMRI")
DATED AS OF DECEMBER 17, 1998, HMRI AND KING HEREBY AGREE AS FOLLOWS:
1. RESPONSIBILITIES
The obligations and responsibilities of either party regarding the drug
regulatory approval, the raw materials, manufacturing, quality control,
complaint handling and drug safety are specified in ANNEX A hereto.
2. RESPONSIBLE PERSONNEL
The personnel responsible for the manufacture and/or the quality control of
the supplied product are specified in ANNEX B hereto. The parties undertake to
keep the other party informed of any changes in such personnel.
IN WITNESS WHEREOF, this Technical Agreement has been duly executed by
the parties as of the date first set forth above.
HOECHST XXXXXX XXXXXXX, INC.
By:
------------------------------------
Name:
----------------------------------
Title:
---------------------------------
KING PHARMACEUTICALS, INC.
By:
------------------------------------
Name:
----------------------------------
Title:
---------------------------------
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
Annex A
to the Technical Agreement between KING and HMRI
RESPONSIBILITIES KING HMRI
---------------- ----- -----
[***]
[***] [***] [***]
[***] [***] [***]
[***] [***] [***]
[***] [***] [***]
[***] [***] [***]
[***] [***] [***]
[***] [***]
[***]
[***] [***]
[***] [***]
[***] [***] [***]
[***] [***]
[***] [***]
[***] [***]
[***] [***] [***]
[***] [***]
[***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***] [***] [***]
[***] [***]
[***] [***]
[***] [***]
[***]
[***] [***] [***]
[***] [***] [***]
X Responsible party
(X) Co-operation necessary
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH
THE SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
Annex B
to the Technical Agreement between KING and HMRI
Responsible Personnel:
FUNCTION: KING HMRI
--------- ----- -----
MANUFACTURING [***] [***] [***]
[***] [***] [***]
[***] [***]
[***] [***] [***]
[***] [***] [***]
PACKAGING [***] [***] [***]
[***] [***] [***]
[***] [***]
[***] [***] [***]
[***] [***] [***]
LABELING [***] [***] [***]
[***] [***] [***]
[***] [***]
[***] [***] [***]
[***] [***] [***]
QUALITY CONTROL [***] [***] [***]
[***] [***] [***]
[***] [***]
[***] [***] [***]
[***] [***] [***]
QUALITY ASSURANCE [***] [***] [***]
[***] [***] [***]
[***] [***]
[***] [***] [***]
[***] [***] [***]
DRUG SAFETY [***] [***] [***]
[***] [***] [***]
[***] [***]
[***]
[***] [***] [***]
[***] [***] [***]
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH
THE SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
