EXHIBIT 10.6
ASSET PURCHASE AGREEMENT
THIS ASSET PURCHASE AGREEMENT (the "Agreement"), dated as of July 27,
2001, (the "Effective Date"), is made and entered into by and between AVENTIS
PHARMACEUTICALS PRODUCTS INC., a Delaware corporation ("Seller"), and QUESTCOR
PHARMACEUTICALS, INC., a California corporation ("Purchaser"). 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, Seller is engaged in business of manufacturing and selling the
Product (as defined herein), with such Product being sold under the Trademarks
(as defined herein); and
WHEREAS, Seller desires to sell, transfer and assign to Purchaser, and
Purchaser desires to purchase and acquire from Seller, any and all rights in,
to and under the Product and related Assets (as defined herein), and in
connection therewith. Purchaser has agreed to assume certain liabilities of
Seller relating to the Product and such Assets, all on the terms and conditions
set forth 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 and sufficiency of which is hereby acknowledged, the parties hereto
hereby agree as follows:
ARTICLE 1
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.
1.1 "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 party specified. For the purposes of this Section 1.1
only, "control" will refer to (a) the possession, directly or indirectly, of the
power to direct the management or policies of a person or entity, whether
through the ownership of voting securities, by contract or otherwise, or (b) the
ownership, directly or indirectly, of at least fifty percent (50%) (or, if less,
the maximum ownership interest permitted by law)of the voting securities or
other ownership interest of an entity.
1.2 "AGREEMENT" shall have the meaning set forth in the preamble.
1.3 "ASSETS" shall have the meaning set forth in Section 2.1 herein.
1.4 "ASSUMED LIABILITIES" shall have the meaning set forth in Section
2.2(a) herein.
1.5 "ATHENA AGREEMENT" shall mean any and all agreements, written or
oral, between Seller or any of its Affiliates and Athena Rx Home Pharmacy, a
division of Elan Pharmaceuticals, Inc.
1.
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 Delaware 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 "EFFECTIVE DATE" shall have the meaning set forth in the preamble.
1.8 "EQUIPMENT" shall have the meaning set forth in Section 2.1(d)
herein.
1.9 "FDA" shall mean the United States Food and Drug Administration or
any successor entity thereto.
1.10 "FDA MEETING" shall mean the February 7, 2001 meeting between
representatives of the FDA, Seller and Purchaser.
1.11 "FINISHED PRODUCT INVENTORY" shall have the meaning set forth in
Section 2.3(b).
1.12 "GOVERNMENTAL OR REGULATORY AUTHORITY" shall mean any court,
tribunal, arbitrator, authority, agency, commission, official or other
instrumentality of the United States or any state, county, city or other
political subdivision within the United States.
1.13 "INDEMNITEE" shall have the meaning set forth in Section 5.2
herein.
1.14 "INDEMNITOR" shall have the meaning set forth in Section 5.2(a)
herein.
1.15 "INVENTORY" shall have the meaning set forth in Section 2.1(e)
herein.
1.16 "KNOWLEDGE" or "knowledge" shall mean actual knowledge after
reasonable investigation by any executive officer of those things which a
reasonably diligent inquiry and exercise of means of information at hand would
have disclosed.
1.17 "LABELING MATERIAL" shall have the meaning set forth in Section
6.3 herein.
1.18 "LAWS" shall mean all laws, statues, rules, regulations,
ordinances and other pronouncements having the effect of law of the United
States or any state, county, city or other political subdivision within the
United States or of any Governmental or Regulatory Authority.
1.19 "LOSSES" shall mean any and all liabilities, debts, obligations,
damages, fines, penalties, deficiencies, losses and expenses (including,
without limitation, interest, court costs, amounts paid in settlement,
reasonable fees of attorneys, accountants and other experts or other reasonable
expenses of litigation or other proceedings or of any claim, default or
assessment).
1.20 "NDA" shall mean the New Drug Application filed with the FDA under
application number 8-372.
1.21 "NET SALES" shall mean total gross invoiced sales of the Product,
including any sales of the Product under any trademark other than the
Trademark, by Purchaser, its Affiliates
and/or their respective assignees, licensees or distributors to a Third Party
end user, less the following deductions to the extent included in such gross
invoiced sales price for the Product, or otherwise directly paid or incurred by
Purchaser, its Affiliates, sublicensees and/or their respective assignees,
licensees or distributors with respect to the sale of the Product to
non-Affiliates:
(a) any rebates, quantity, trade and cash discounts, retroactive
price reductions, and other usual and customary discounts to customers accrued
and subsequently paid, in the ordinary course of business;
(b) returns;
(c) freight, transportation, postage and insurance to the extent
included in the invoice price; and
(d) sales taxes, tariffs, duties and other governmental charges
(including value added tax) actually paid in connection with the sale (but
excluding income taxes).
1.22 "NORD AGREEMENT" shall mean any and all agreements, written or
oral, between Seller or any of its Affiliates and the National Organization for
Rare Disorders, Inc.
1.23 "PRODUCT" shall mean any and all dosage forms of the finished
product that have corticotropin as such product's active ingredient that Seller
has rights to.
1.24 "PROPRIETARY RIGHTS" shall have the meaning set forth in Section
2.1(c) herein.
1.25 "PURCHASE PRICE" shall have the meaning set forth in Section 2.3
herein.
1.26 "PURCHASER" shall have the meaning set forth in the preamble.
1.27 "REGULATORY DOCUMENTS" shall have the meaning set forth in Section
2.1(b) herein.
1.28 "REMAINING INVENTORY" shall have the meaning set forth in Section
2.3(b) herein.
1.29 "RETAINED LIABILITIES" shall have the meaning set forth in Section
2.2(b) herein.
1.30 "ROYALTY PAYMENT" shall have the meaning set forth in Section
2.3(c) herein.
1.31 "SELLER" shall have the meaning set forth in the preamble.
1.32 "THIRD PARTY" shall mean a person or entity other than Seller,
Purchaser or Affiliates of either.
1.33 "TRADEMARKS" shall mean ACTHAR and ACTHAR GEL.
ARTICLE 2
SALE OF ASSETS, LICENSE GRANT, CLOSING
AND CERTAIN POST-CLOSING OBLIGATIONS
2.1 SALE OF ASSETS. As of the Effective Date, and subject to the terms
and conditions of this Agreement, Seller hereby sells, assigns, conveys,
transfers, and delivers to Purchaser, and Purchaser purchases and accepts from
Seller, the following assets related to the Product (collectively, the
"Assets"):
(a) any and all of Seller's and its Affiliates' rights, title, and
interests in, to and under the Trademarks in any country of the world, together
with the goodwill of the business symbolized by the Trademarks, including but
not limited to, common law rights and the registrations listed in SCHEDULE
2.1(a) attached hereto;
(b) any and all of Seller's and its Affiliates' rights, title, and
interest in, to and under the NDA and all related regulatory filings, and any
regulatory filings of Seller for the Product outside the United States (if
any), and including, without limitation, all documents related to the safety
database and medical information files for the Product (collectively, the
"Regulatory Documents");
(c) any and all of Seller's and its Affiliates' rights, title and
interest in, to and under any and all know-how and other proprietary rights
owned and/or controlled by Seller or its Affiliates and used in the manufacture
and/or testing of the Product, including, without limitation, records,
processes and procedures used in the extraction process, biological assay
testing and manufacturing of the Product (collectively, the "Proprietary
Rights");
(d) the equipment set forth on SCHEDULE 2.1(d) attached hereto (the
"Equipment"); and
(e) the Product inventory set forth on SCHEDULE 2.1(e) attached
hereto delivered to Purchaser in accordance with the terms and conditions of
this Agreement, consisting of finished Product, work-in-progress, raw
materials (active ingredients and excipients), packaging materials and other
supplies and materials on hand, to the extent used exclusively in the
production of the Product (collectively, the "Inventory"). Inventory held
pursuant to the terms of the Athena Agreement at Athena Rx Home Pharmacy's
place of business is expressly excluded from the Assets.
2.2 LIABILITIES.
(a) ASSUMED LIABILITIES. On the Effective Date, and subject to the
terms and conditions of this Agreement, Purchaser assumes and agrees to pay,
perform and discharge when due the following liabilities and obligations
arising in connection with the Assets (the "Assumed Liabilities"):
(i) OBLIGATIONS UNDER THE TRADEMARKS AND REGULATORY DOCUMENTS.
All liabilities and obligations under the Trademarks and the Regulatory
Documents arising and to be performed on or after the Effective Date.
(ii) MEDICAID/MEDICARE REBATES; CHARGEBACKS; CREDITS.
(1) State and federal Medicaid/Medicare rebates in
connection with the Product sold by Purchaser after the Effective Date;
(2) Chargeback rebates and similar payments to
wholesalers and other distributors in connection with the Product in the
Territory beginning one month after the Effective Date; and
(3) Credits, utilization based rebates, reimbursements,
and similar payments to buying groups, insurers and other institutions in
connection with the Product sold by Purchaser after the Effective Date.
(iii) RECALLS. From and after the Effective Date, all
liabilities, obligations and responsibilities relating to voluntary and
involuntary recalls of units of the Product sold by Purchaser after the
Effective Date.
(iv) PRODUCTS LIABILITY. From and after the Effective Date,
all liabilities, obligations and responsibilities relating to product liability
claims or threatened claims relating to units of the Product sold by Purchaser
after the Effective Date; provided, however, that liability for such claims or
threatened claims shall not be assumed by Purchaser solely to the extent such
claims arise from: (i) the manufacturing, storage or handling of Finished
Product Inventory by Seller or its Affiliates before shipment of such Finished
Product Inventory to Purchaser; and (ii) the storage or handling of the
Remaining Inventory by Seller or its Affiliates after the Effective Date.
(v) RETURNS. From and after the Effective Date, all
liabilities and obligations with respect to return of units of Product,
provided that Seller shall reimburse Purchaser for the actual cost of credits
given to the trade for returned Product with respect to returns received at any
time regarding units of Product sold by Seller prior to the Effective Date.
Purchaser shall provide Seller with reasonably detailed documentation for any
costs to be reimbursed by Seller hereunder and Seller shall have the right to
audit such documentation pursuant to the procedures set forth in Section 2.6(d)
herein.
(b) RETAINED LIABILITIES. Except for the Assumed Liabilities and as
set forth in this Agreement, Purchaser shall not assume by virtue of this
Agreement or the transactions contemplated hereby, and shall have no liability
for, any Losses of Seller of any kind, character or description whatsoever or
wheresoever, including, but not limited to, any obligations or Losses with
respect to the NORD Agreement, the Athena Agreement or distribution of Product
by Seller pursuant to such Agreements (the "Retained Liabilities").
2.3 PURCHASE PRICE. Subject to the terms and conditions of this Agreement,
Purchaser shall pay to Seller as full and fair consideration for the Assets the
following consideration (the "Purchase Price"):
(a) Upon the later to occur of (i) the date of the first commercial
shipment of Product by Purchaser to a Third Party or (ii) the date that is
ninety (90) days after the Effective
Date, Purchaser shall pay to Seller * by wire transfer to an account designated
by Seller; and
(b) Upon the later to occur of (i) the date of the first commercial
shipment of Product by Purchaser to a Third Party or (ii) the date that is
ninety (90) days after the Effective Date, Purchaser shall pay Seller * per vial
as the total purchase price for all of the filled and labeled vials of finished
Product in the Inventory and available for sale to Purchaser as of the Effective
Date (the "Finished Product Inventory"), an estimate of which is set forth on
SCHEDULE 2.1(e) attached hereto. In addition, in accordance with the provisions
of Section 2.5 herein, Purchaser shall pay Seller for any of the Inventory
described on SCHEDULE 2.1(e) other than the Finished Product Inventory purchased
as described in the first sentence of this Section 2.3(b), including any of the
frozen mini-bombs of active raw ingredient, that is used by Purchaser to produce
product to be sold by Purchaser to the trade, (the "Remaining Inventory"), such
Inventory to be sold to Purchaser by Seller at a purchase price equal to
Seller's standard costs for such Inventory, the standard costs for which are set
forth on SCHEDULE 2.1(e), and payment shall be due and payable upon receipt of
such Inventory delivered in accordance with Section 2.5; and provided, however,
that Purchaser shall not be obligated to purchase any more than one hundred
twenty five percent (125%) of the estimate set forth on SCHEDULE 2.1(e); and
(c) for so long as Purchaser, any of its Affiliates or any of its
licensees, or any of their respective successors or assigns, sells the Product,
Purchaser shall pay to Seller an annual royalty equal to * in any given calendar
year (the "Royalty Payment"), pursuant to the terms and conditions of Section
2.6 herein.
2.4 GRANT OF SECURITY INTEREST. Purchaser hereby grants to Seller a
purchase money security interest in and to the Assets, as security solely for
the performance by Purchaser of its payment obligations only for the portion of
the Purchase Price set forth in Sections 2.3(a) and 2.3(b), together with the
right of Seller to repossess the Assets with reasonable advance written notice
in the event such obligations are not paid in full within (30) days after
becoming due and payable (the "Security Interest"). Purchaser agrees to execute
all documents, including without limitation, an UCC-1 Financing Statement or its
equivalent, reasonably necessary for Seller to perfect the Security Interest.
The Security Interest shall terminate automatically upon receipt by Seller of
the payments set forth in Sections 2.3(a) and 2.3(b). Promptly upon receipt of
such payments, Seller shall execute all documents reasonably necessary to remove
and eliminate the Security Interest, including, without limitation, any liens
arising therefrom.
2.5 INVENTORY.
(a) FINISHED PRODUCT INVENTORY. Promptly after the Finished
Product Inventory has been relabeled as provided in Section 6.3, Seller shall
ship to Purchaser, FOB Seller's distribution facility on a carrier designated by
Purchaser, all of such relabeled Finished Product Inventory. Payment for such
Finished Product Inventory shall be made by Purchaser as described in Section
2.3(b) hereof.
* Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
(b) REMAINING INVENTORY. Seller shall retain the Remaining
Inventory in Seller's possession and control after the Effective Date and
until: (i) such Remaining Inventory is used by Seller to manufacture filled and
labeled vials of finished Product from all or any part of such Remaining
Inventory pursuant to Section 6.1(a); and/or (ii) Seller ships all or any part
of such Remaining Inventory to Purchaser or to a Third Party designated by
Purchaser. Notwithstanding the other provisions of this Section 2.5(b), Seller
shall have no obligation to retain or maintain such Remaining Inventory longer
than one (1) year after the Effective Date and Purchaser expressly acknowledges
that Remaining Inventory may be used in manufacturing under the Supply
Agreement and may be unavailable or available in different quantities
thereafter as set forth herein. Payment for such Remaining Inventory shall be
made by Purchaser as described in Section 2.3(b) hereof. During the period
after the Effective Date that Seller remains in possession and control of the
Remaining Inventory, Seller shall use reasonable commercial efforts to maintain
such Remaining Inventory in accordance with the specifications therefor.
(c) SHIPPING. All shipments hereunder shall be FOB Seller's
distribution facility and the risk of loss for such shipments shall pass to
Purchaser upon the transfer of the Inventory to the carrier designated by
Purchaser for each such shipment. Seller shall, at its sole cost and expense,
package and label Finished Product Inventory and Remaining Inventory (to the
extent purchased by Purchaser) for shipping to Purchaser using reasonable
commercial diligence to prevent breakage, spoilage or damage to such Finished
Product Inventory and Remaining Inventory.
2.6 ROYALTY PAYMENTS.
(a) ANNUAL REPORT AND PAYMENT. Within thirty (30) days after the
end of each calendar year following the Effective Date during which Purchaser
records any Net Sales, Purchaser shall provide to Seller a written report
setting forth in reasonable detail, including, without limitation, the
deductions taken in computing Net Sales, the total amount of Net Sales for such
calendar year and the amount of any Royalty Payment due to Seller based on (i)
the Net Sales for such calendar year and (ii) the Royalty Payment terms and
conditions set forth in Section 2.3(c) herein. Each such annual report shall
include payment in the amount of any Royalty Payment due to Seller for the
calendar year to which the annual report relates.
(b) TAXES. Any tax required to be withheld by Purchaser on Royalty
Payments due Seller hereunder shall be deducted from the amount of Royalty
Payments otherwise due, and Purchaser shall supply Seller with appropriate
evidence of such tax and payment thereof.
(c) BOOKS AND RECORDS. Purchaser shall, and shall require its
licensees or distributors to, maintain full and complete books and records of
all information necessary for the computation of Net Sales and the royalties
payable hereunder for a period of three (3) years after the end of the fiscal
year to which they relate. All such books and records shall be maintained in
accordance with generally accepted accounting principles consistently applied.
(d) AUDIT RIGHTS. Upon reasonable prior written notice to
Purchaser, Seller shall have the right at any time (but no more often than once
yearly and in any event within three
(3) years after the close of the year to which the audit relates) to have an
audit performed of the books of account and other records of Purchaser during
normal business hours for the sole purpose of verifying the Royalty Payments
made hereunder. The fees and expenses of any such audit shall be borne by
Seller, except in the event that the audit reveals an underpayment of more than
five percent (5%) of the actual amount determined to be due, whereupon such
fees and expenses shall be borne by Purchaser. Purchaser shall within sixty
(60)days of the results of such audit provide for payment of amounts which are
underpaid, unless a bona fide dispute exists as to the results of such audit.
2.7 DELIVERY OF DOCUMENTATION. Within twenty (20) days after the
Effective Date, Seller shall, at its sole cost and expense, deliver to
Purchaser, at the address set forth in Section 7.3 herein, originals of the
materials comprising the Regulatory Documents (provided that Seller
shall have the right to retain one copy of such Regulatory Documents solely for
its archival purposes); provided, however, that if, Purchaser receives an
inquiry from the FDA or an equivalent foreign regulatory agency relating to the
Product, then Seller shall use its best efforts to deliver to Questcor such
documentation within ten (10) days of the Effective Date or allow Questcor to
have access to such documentation at its current location so that Questcor may
respond as necessary to such inquiry.
2.8 TAXES. Purchaser shall be responsible for and shall promptly pay all
federal, state, and local transfer, sales, and other taxes, if any, levied or
imposed as a result of the transactions contemplated by this Agreement,
excluding any tax payable on any income or gain of Seller.
2.9 FURTHER ACTION BY THE PARTIES. Each of the parties shall use its
reasonable commercial efforts to take all actions and to do all things
necessary, proper, or advisable in order to consummate and make effective the
transactions contemplated by this Agreement.
ARTICLE 3
REGULATORY MATTERS
3.1 FILINGS WITH GOVERNMENTAL OR REGULATORY AUTHORITIES REGARDING
TRANSFER OF THE NDA AND FOREIGN EQUIVALENTS.
(a) On or promptly after the Effective Date, but not later than ten
(10) days after the Effective Date, the parties shall each file with the FDA a
letter containing any information required pursuant to 21 C.F.R. Section 314.72,
or any successor regulation thereto, regarding the transfer of ownership of the
NDA from Seller to Purchaser (the "Notification Letters"). In their respective
Notification Letters, Seller shall file the information required of a former
owner of the NDA, and Purchaser shall file the information required of a new
owner of the NDA. The parties shall file such Notification Letters in a form
similar to the sample letters set forth in SCHEDULE 3.1. The parties also agree
to use their best efforts to take any and all other actions required by the FDA,
or other necessary Governmental or Regulatory Authorities, if any, to effect the
transfer of the NDA from Seller to Purchaser. Seller may retain an archival copy
of the NDA, including supplements and records that are required to be kept under
21 C.F.R. Section 314.81.
(b) Seller shall transfer to Purchaser, at Purchaser's request and
sole expense, any Regulatory Documents relating to filings equivalent to the NDA
made outside the United States. In addition, Seller will use its best efforts,
at Purchaser's request and sole cost and expense, to cause its Affiliates to
transfer any regulatory filings of Seller's Affiliates for the Product outside
the United States (if any).
3.2 RESPONSIBILITY FOR THE ASSETS AND THE PRODUCT.
(a) Subject to Section 6.1(b), on the date of receipt by the FDA of
the Notification Letter of Seller, Purchaser shall assume all regulatory
responsibilities permitted by applicable laws and regulations to be assumed by
Purchaser, reporting and otherwise, in connection with the Assets and the
Product including, but not limited to, responsibility for reporting any adverse
drug events in connection with the Product, and responsibility for compliance
with the Prescription Drug Marketing Act of 1987, as the same may be amended
from time to time; provided however, that from the Effective Date until the date
that the FDA is notified of such transfer, Purchasers shall only be obligated to
assume such responsibilities to the extent permitted by law, and the parties
shall work together to assure that such obligations are met during such period.
(b) The parties will agree upon procedures to ensure a smooth
transition from Seller to Purchaser of the activities required to be undertaken
by the holder of the NDA.
(c) Upon the Effective Date, Purchaser shall assume all
responsibility for any and all fee obligations for holders or owners of approved
new drug applications and approved, marketed prescription drug products relating
to the Assets and Product, including, but not limited to, those defined under
the Prescription Drug User Fee Act of 1992, as the same may be amended from time
to time.
(d) Promptly after the Effective Date, Purchaser and Seller shall
take all actions necessary or required under applicable Laws to reflect that the
Assets are owned by Purchaser and the Purchaser has responsibility therefor.
ARTICLE 4
REPRESENTATIONS AND WARRANTIES
4.1 REPRESENTATIONS AND WARRANTIES OF SELLER. Seller represents and
warrants to Purchaser as follows:
(a) ORGANIZATION AND STANDING. Seller is a corporation, duly
organized, validly existing and in good standing under the laws of the
jurisdiction of its incorporation.
(b) POWER AND AUTHORITY. Seller has all requisite corporate or
limited liability company power and authority to execute, deliver, and perform
this Agreement and the other agreements and instruments to be executed and
delivered by it pursuant hereto and to consummate the transactions contemplated
herein and therein. The execution, delivery, and performance of this Agreement
by Seller does not, and the consummation of the transactions contemplated hereby
will not, violate any provisions of Seller's organizational documents,
bylaws, any law or regulation applicable to Seller, or any agreement, mortgage,
lease, instrument, order, judgment, or decree to which Seller is a party or by
which Seller is bound or result in the creation or acceleration of any lien
charge, security interest, or other encumbrance on the Assets.
(c) CORPORATE ACTION; BINDING EFFECT. Seller has duly and properly
taken all action required by law, its organizational documents, or otherwise,
to authorize the execution, delivery, and performance of this Agreement and the
other instruments to be executed and delivered by it pursuant hereto and the
consummation of transactions contemplated hereby and thereby. This Agreement
has been duly executed and delivered by Seller and constitutes, and the other
instruments contemplated hereby when duly executed and delivered by Seller will
constitute, legal, valid, and binding obligations of Seller enforceable against
it in accordance with their respective terms, except as enforcement may be
affected by bankruptcy, insolvency, or other similar laws and by general
principles of equity as applied by a court of competent jurisdiction.
(d) CONSENTS. No consent or approval of, or filing with or notice
to, any Governmental or Regulatory Authority or any other person not a party to
this Agreement is required or necessary to be obtained by Seller or on its
behalf in connection with the execution, delivery, and performance of this
Agreement or to consummate the transactions contemplated hereby, except as
contemplated by Section 3.1 hereof.
(e) OWNERSHIP OF ASSETS; CONDITION OF ASSETS. Seller is the sole
owner of the Assets and the Assets are free and clear of all liens, claims,
charges, or encumbrances.
(f) FINISHED PRODUCT INVENTORY WARRANTY. The Finished Product
Inventory delivered hereunder shall conform to the specifications therefor, and
shall have been manufactured in accordance with cGMP and the manufacturing
process as approved by the FDA at the time of manufacture.
(g) LITIGATION OR DISPUTES. There is no claim, outstanding
commitment to any governmental regulatory agency, action, suit, proceeding,
investigation, or arbitration pending or, to Seller's knowledge, threatened
against Seller relating to the Assets, and Seller is not in violation of or in
default with respect to any applicable law, rule, regulation, judgment, order,
writ, injunction, award, or decree of any arbitrator, court, or administrative
body, the result of any of which, either individually or cumulatively, would
have a materially adverse effect on the Assets or Seller's compliance with and
performance under the terms of this Agreement.
(h) PATENTS, TRADEMARKS AND PROPRIETARY RIGHTS.
(i) Seller is not aware of any unexpired patent that claims
or covers any of the Assets owned by Seller (the "Patent"). To the extent that
a Patent or patent application exists as of the Effective Date of this
Agreement, Seller covenants not to xxx Purchaser under such Patent or any other
patent issuing from a patent application that claims priority to the patent
application that issued into such Patent.
(ii) There is no claim, action, suit, or proceeding, pending
or, to Seller's Knowledge, threatened alleging that the use by Seller or its
Affiliates of the Trademarks or the Proprietary Rights infringes any
intellectual property rights of third parties.
(iii) Seller has not executed or granted to any Affiliate or
any Third Party any license, sublicense, or contract covering the Trademarks or
the Proprietary Rights.
(i) EQUIPMENT. The equipment listed on Schedule 2.1(d) is all the
equipment solely dedicated to the extraction process of the manufacture (but
not the filling process) and testing of the Product in Seller's Kankakee, IL,
plant.
4.2 REPRESENTATIONS AND WARRANTIES OF PURCHASER. Purchaser represents
and warrants to Seller as follows:
(a) ORGANIZATION AND STANDING. Purchaser is a corporation duly
organized, validly existing and in good standing under the laws of the State of
California.
(b) POWER AND AUTHORITY. Purchaser has all requisite corporate
power and authority to execute, deliver, and perform this Agreement, and the
other agreements and instruments to be executed and delivered by it pursuant
hereto and to consummate the transactions contemplated herein and therein. The
execution, delivery, and performance of this Agreement by Purchaser do not, and
the consummation of the transactions contemplated hereby will not, violate any
provision of Purchaser's articles of incorporation, bylaws, any law or
regulation applicable to Purchaser, or any agreement, mortgage, lease,
instrument, order, judgment, or decree to which Purchaser is a party or by
which Purchaser is bound.
(c) CORPORATE ACTION; BINDING EFFECT. Purchaser has duly and
properly taken all action required by law, its articles of incorporation, its
bylaws, or otherwise, to authorize the execution, delivery, and performance by
it of this Agreement and the other instruments to be executed by it pursuant
hereto and the consummation of the transactions contemplated hereby and thereby.
This Agreement has been duly executed and delivered by Purchaser and
constitutes, and the other instruments contemplated hereby when duly executed
and delivered by Purchaser will constitute, legal, valid, and binding
obligations of Purchaser enforceable against it in accordance with their
respective terms, except as enforcement may be affected by bankruptcy,
insolvency, or other similar laws and by general principles of equity as applied
by a court of competent jurisdiction.
(d) CONSENTS. No consent or approval of, or filing with or notice
to, any federal, state, or local governmental or regulatory authority, agency,
or department or any other person not a party to this Agreement is required or
necessary to be obtained by Purchaser or on its behalf in connection with the
execution, delivery, and performance of this Agreement or to consummate the
transactions contemplated hereby, except as contemplated by Section 3.1 hereof.
4.3 SURVIVAL OF REPRESENTATIONS/WARRANTIES. The representations and
warranties contained in this Article IV, and that portion of the
indemnification with respect thereto pursuant to Article V, shall survive the
Effective Date and continue in effect for a period of one (1) year
thereafter, except for the representation set forth in Section 4.1(f) which
shall survive beyond such one (1) year period.
4.4 BROKERS. Each party hereby represents that all negotiations relative
to this Agreement and the transactions contemplated hereby have been carried
out by each such party directly with the other party without the intervention
of any Third Party on behalf of either party in such manner as to give rise to
any valid claim by any Third Party against either party for a finder's fee,
brokerage commission or similar payment.
4.5 MANUFACTURING PROCESS. Purchaser hereby acknowledges and agrees that
the Assets and Product are being sold hereunder on an 'as is' compliance basis
with respect to the manufacture of the Product in accordance with the FDA's
position at the FDA Meeting and that Seller makes no representation or warranty
or in any way guarantees that the FDA will issue minutes of the FDA Meeting
that reflect the FDA's consent to allow the manufacture of the Product as it is
being manufactured by Seller as of the Effective Date, or that the FDA will
continue to allow the manufacture in such manner in the future, regardless of
the FDA's position in the minutes of the FDA Meeting. Purchaser acknowledges
that the FDA has not approved or issued minutes of the FDA Meeting documenting
the FDA's consent to manufacture in the manner set forth at the FDA Meeting,
and Purchaser accepts any risk associated therewith. Accordingly, Purchaser
accepts any and all risks of Losses associated with any change of the FDA's
position from that set forth at the FDA Meeting regarding the manufacture of
the Product.
4.6 DISCLAIMER OF WARRANTIES. EXCEPT AS EXPRESSLY PROVIDED HEREIN, SELLER
DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, WITH REGARD TO THE ASSETS
AND THE PRODUCT, INCLUDING, BUT NOT LIMITED TO, THE WARRANTY OF MERCHANTABILITY
AND THE WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE.
4.7 AS-IS ACKNOWLEDGEMENT. Except as expressly set forth herein,
Purchaser acknowledges that the Assets are being sold hereunder on an as-is
basis, the Assets are being sold with no representations made by Seller as to
condition of the Assets.
4.8 PATENT ACKNOWLEDGEMENT. Purchaser acknowledges that other parties,
including without limitation American Medical Technologies, may have filed
patent applications claiming or covering products that have corticotropin as an
active ingredient, and that Seller has done no investigation with respect to
such patent applications.
ARTICLE 5
INDEMNIFICATION
5.1 INDEMNIFICATION.
(a) Subject to Section 5.1(c) and Section 5.2, Seller shall
indemnify Purchaser and its officers, directors, employees, agents and
Affiliates in respect of, and hold each of them harmless from and against, any
and all Losses suffered, incurred or sustained by any of them or to which any
of them becomes subject, resulting from arising out of, or relating to,:
(i) The Retained Liabilities; and
(ii) For the term set forth in Section 4.3
misrepresentation or breach of any warranty or covenant by Seller made or
contained in this Agreement; and
(iii) Litigation or other claims arising from acts failures
to act or events relating to the Assets or the Product which occurred prior to
the Effective Date; and
(iv) The use, storage or transportation of the Products
before the Effective Date; and
(v) The testing performed by Seller pursuant to Section
6.1(b).
Notwithstanding any provision herein to the contrary the parties agree
that in no event will Seller be liable to Purchaser for special, consequential,
indirect, punitive or similar damages; provided however, that indemnification
claims for Losses arising solely out of third party claims shall not be so
limited.
(b) Subject to Section 5.1(c) and Section 5.2 Purchaser shall
indemnify Seller and its officers, directors, employees, agents and Affiliates
in respect of, and hold each of them harmless from and against, any and all
Losses suffered, incurred or sustained by any of them or to which any of them
becomes subject, resulting from, arising out of or relating to:
(i) The Assumed Liabilities; and
(ii) For the term set forth in Section 4.3,
misrepresentation or breach of any warranty or covenant by the Purchaser made or
contained in this Agreement; and
(iii) Litigation or other claims arising from acts,
failures to act or events relating to the Assets or the Product that occur on
or after the Effective Date; except for claims arising from: (1) the
manufacturing, storage or handling of Finished Product Inventory by Seller or
its Affiliates before shipment of such Finished Product Inventory to Purchaser;
and (2) the storage or handling of the Remaining Inventory by Seller or its
Affiliates after the Effective Date.
(iv) the use of the Assets on or after the Effective Date,
except those Assets that remain within Seller's exclusive control.
(v) The manufacture or testing of the Assets or the
Products by Purchaser or a Third Party appointed by Purchaser; and
(vi) Any cartons, package inserts, labels or any other
supplies provided by Purchaser.
Notwithstanding any provision herein to the contrary, the parties agree
that in no event will Purchaser be liable to Seller for special, consequential,
indirect, punitive or similar damages.
(c) Notwithstanding anything to the contrary contained in this
Agreement, no amounts of indemnity shall be payable as a result of any claim in
respect of any Losses arising under paragraph (a) or (b) of Section 5.1:
(i) unless, until and then only to the extent that the
Indemnified Parties thereunder have suffered, incurred, sustained or become
subject to Losses referred to in such paragraphs in excess of Twenty-Five
Thousand Dollars ($25,000) in the aggregate;
(ii) with respect to any Losses, to the extent that the party
seeking indemnification had a reasonable opportunity, but failed, in good faith
to mitigate such Losses, including, but not limited to, the failure to use
commercially reasonable efforts to recover under such party's policy of
insurance or under a contractual right of set-off or indemnity; or
(iii) with respect to any Losses, to the extent that such
Losses are caused by (a) any inaccuracy of a representation or breach of a
warranty made by the party seeking indemnification in the Agreement or (b) the
gross negligence or intentional misconduct of such party or any of its officers,
directors, employees, agents or Affiliates.
5.2 METHOD OF ASSERTING CLAIMS. A party (the "Indemnitee") that intends
to claim indemnification under this Article V shall:
(a) notify the other party (the "Indemnitor") in writing of any
Losses with respect to which the Indemnitee intends to claim indemnification as
soon as practicable after the Indemnitee becomes aware of any such Losses;
(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 V shall not apply to amounts paid in settlement of any Losses 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 potential
Losses shall not relieve the Indemnitor of any liability to the Indemnitee
pursuant to this Article V, except to the extent such delay prejudices the
Indemnitor's ability to defend such action. The Indemnitor shall not settle or
compromise any claim or Losses in any manner that admits fault on the part of
the Indemnitee without the express prior written consent of the Indemnitee,
which consent may be withheld for any reason or no reason.
ARTICLE 6
TRANSITION SERVICES
6.1 PRODUCT SUPPLY AND TESTING.
(a) SUPPLY. If needed by Purchaser and only until the earlier to
occur of (i) such time as manufacturing of the Product can be transferred to
Purchaser or its designated Third Party supplier or (ii) twelve (12) months
following the Effective Date, Seller shall, at Purchaser's written request,
manufacture, and fill and label vials of, finished Product from existing
mini-bombs of raw active ingredient in the Remaining Inventory pursuant to terms
and conditions of a supply agreement to be negotiated and agreed upon in good
faith by and between the parties; provided that the price shall be * per vial of
filled and labeled finished Product and the other terms and conditions of such
manufacture shall be consistent with Seller's previous manufacture of filled and
labeled vials of Product for its own use.
(b) TESTING. Seller will perform, at its sole cost and expense, any
and all testing of all batches of the Finished Product Inventory and related
tasks that Seller has, as of the Effective Date, committed to the FDA to perform
on the Finished Product Inventory produced by Seller prior to the Effective
Date, such testing commitments consisting solely of stability testing on lots of
Finished Product Inventory manufactured by Seller until the second anniversary
of the manufacture of such lots. For purposes of clarity, this obligation
relates solely to Finished Product Inventory manufactured before the date
hereof. Any testing related to Products produced pursuant to Section 6.1(a) will
be set forth in the supply agreement, which is described in Section 6.1(a).
6.2 TRANSFER OF PRODUCT MANUFACTURING AND TESTING.
(a) SITE IDENTIFICATION; TIMETABLE. Subject to Section 6.1(a),
Purchaser shall identify sites for the manufacture of the active ingredient for,
and finished dosage forms of, the Product, and for the testing of the Product
and the active ingredient, components and intermediates that is required by the
FDA or similar regulatory agency. Seller shall transfer the manufacturing and
testing of the active ingredient, components and intermediates and the finished
Product to such sites as set forth on SCHEDULE 6.2 in accordance with the
provisions of Section 6.2(b) herein.
(b) SELLER'S OBLIGATIONS. Seller will provide Purchaser with
assistance in transferring the manufacturing and testing of the
Product and the active ingredient, components and intermediates to Purchaser or
its designated Third Party suppliers, including the shipment of the Equipment
to, and re-installation of the Equipment at, the applicable transferee site and
the training of employees of Purchaser or its designated Third Party suppliers
on the manufacturing and testing processes. SCHEDULE 6.2 sets forth the project
team and a projected timeline for the transfers. The costs and expenses of
preparing and shipping the Equipment to the Third Party sites and any Seller
costs or expenses related to such training and/or consultation services provided
by Seller or its Affiliates at the Kankakee, Illinois manufacturing site shall
be at Seller's sole cost and expense. Purchaser shall reimburse Seller for all
costs and expenses related to assistance with re-installing Equipment at the
Third Party sites and any training and/or
* Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
consulting services performed by Seller or its Affiliate at locations outside
of the Kankakee, Illinois manufacturing site at a rate of One Thousand Dollars
($1,000) per person per day plus reasonable travel expenses.
(c) PAYMENT. Purchaser shall pay Seller for the costs and
expenses to be reimbursed by Purchaser to Seller pursuant to Section 6.2(b)
herein within thirty (30) days after Purchaser's receipt of each invoice from
Seller for such costs and expenses. Each Seller invoice shall include
reasonable details and documentation regarding the costs and expenses being
invoiced by Seller for services rendered pursuant to Section 6.2(b) herein.
6.3 RELABELING. Seller shall relabel such amount of the Finished Product
Inventory as Purchaser shall request (which amount shall allow a reasonable
number of vials to not be relabeled and remain available to Athena for use in
administration of the NORD program until such program is terminated by Seller)
using such materials ("Labeling Materials") as Purchaser shall make available
to Seller. Seller shall use commercially reasonable efforts to complete such
relabeling no later than 8 weeks after receipt of the last to be received
Labeling Materials. Such relabeling shall be performed in accordance with
Seller's standard procedures for such relabeling. The cost for such relabeling
shall be * per vial.
ARTICLE 7
GENERAL PROVISIONS
7.1 PAYMENT OF TRANSACTION EXPENSES. All legal fees and other expenses
incurred on behalf of Seller in connection with the negotiation of this
Agreement and the consummation of the transactions contemplated herein will be
borne by Seller; and all legal fees and other expenses incurred on behalf of
Purchaser in connection with the negotiation of this Agreement and the
consummation of the transactions contemplated herein will be borne by Purchaser.
7.2 NO OTHER REPRESENTATIONS. Except as expressly set forth in this
Agreement, neither Seller nor Purchaser are making any representation or
warranty whatsoever, express or implied, including, but not limited to, any
implied representation or warranty as to condition, merchantability or
suitability as to any of the Assets. In particular, Seller does not make any
representation or warranty to Purchaser with respect to (i) the information
set forth in the offering materials provided to Purchaser by Seller or (ii) any
financial projection or forecast relating to the business prospects for the
Product. With respect to any projection or forecast delivered by or on behalf of
Seller to Purchaser, Purchaser acknowledges that (i) there are uncertainties
inherent in attempting to make such projections and forecasts, (ii) it is
familiar with such uncertainties, (iii) it is taking full responsibility for
making its own evaluation of the adequacy and accuracy of all such projections
and forecasts furnished to it and (iv) it shall have no claim against Seller
with respect to such projections and forecasts prepared in good faith by Seller.
7.3 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
* Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
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 Purchaser, to:
Questcor Pharmaceuticals, Inc.
0000 Xxxxxxx Xxxx
Xxxxx Xxxx, Xxxxxxxxxx 00000
Attn: Vice President, Sales & Marketing
Facsimile: 000-000-0000
If to Seller, to:
Aventis Pharmaceuticals Products Inc.
000 Xxxxxxxx Xxxxxxxxx Xxxxxx
Xxxxxxxxxxx, Xxx Xxxxxx 00000-0000
Attn: Vice President, Business Development
Facsimile: 000-000-0000
with a copy to:
Aventis Pharmaceuticals Products Inc.
000 Xxxxxxxx Xxxxxxxxx Xxxxxx
Xxxxxxxxxxx, Xxx Xxxxxx 00000-0000
Attn: General Counsel North America
Facsimile: 000-000-0000
(b) Any such notice or other document shall be deemed to have been
received by the addressee three (3) business days 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.
7.4 LATE PAYMENTS. Any payments due to Seller hereunder that are not
received within thirty (30) days of the date on which such payment is due shall
accrue interest 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 three percent (3%) or
(ii) the maximum rate permitted by law, such interest to begin accruing on a
daily basis from the date of invoice or the date the payment is due hereunder,
as the case may be, and shall accrue both before and after any judgment rendered
with respect thereto by a court of competent jurisdiction.
7.4 ENTIRE AGREEMENT; AMENDMENT.
(a) This Agreement, together with the Schedules attached hereto,
embodies and sets forth the entire agreement and understanding of the parties
with respect to the subject
matter herein and there are no promises terms, conditions or obligations,
oral or written, expressed or implied, other than those contained herein. The
terms of this Agreement shall supersede all previous and contemporaneous oral
or written agreements which may exist or have existed between the parties
relating to the subject matter of this 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 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.
7.6 ASSIGNMENT. No party shall be entitled to assign its rights and
obligations hereunder without the prior written consent of the other party;
provided, however, a party shall be entitled, without the prior written consent
of the other party, 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 7.6 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.
7.7 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.
7.8 ATTACHMENTS. All Schedules referenced herein are hereby made a part
of this Agreement.
7.9 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.
7.10 GOVERNING LAW. This Agreement shall be governed by and construed
under the laws of the State of Delaware, without giving effect to the choice of
law provisions thereof.
7.11 DISPUTE RESOLUTION. If a dispute or claim relating to or arising from
this Agreement cannot be resolved by representatives of the parties in the
ordinary course of business, then such dispute or claim shall be referred in
writing and by referencing this Section 7.11 to the President of Seller and the
Chief Executive Officer of Purchaser, respectively. If such officers are unable
to resolve such dispute or claim presented to them under the preceding sentence
within thirty (30) days of referral, then either party may take whatever action
is available to it under law and equity.
7.12 NO WAIVER. Neither the failure nor delay on the part of either 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.
7.13 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 agreed to by
the Parties in writing and substituted for the invalid or unenforceable
provision 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.
7.14 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.
7.15 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.
7.16 THIRD PARTY BENEFICIARIES. This Agreement is not intended to confer
upon any Third Party rights or remedies hereunder, except as may be received or
created as part of a valid assignment.
7.17 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
expressly set forth in this Agreement.
7.18 TERMS OF THIS AGREEMENT. The parties agree not to disclose any terms
or conditions of this Agreement to any Third Party without the prior written
consent of the other party, except to advisors, investors, lenders and others
on a need-to-know basis under conditions which reasonably ensure the
confidentiality thereof or for disclosures only of the existence and general
subject matter of this Agreement, or to the extent required by applicable
Laws; provided, however, prior to any such required disclosure 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 two (2) business days of the
non-disclosing party's receipt of the proposed disclosure and the disclosing
party shall seek confidential treatment for such disclosure as permitted by
applicable Laws.
IN WITNESS WHEREOF, the parties hereto have each caused this
Agreement to be duly executed as of the date first above written.
SELLER:
AVENTIS PHARMACEUTICALS PRODUCTS INC.
By: /s/ XXXX X. XXXXX
________________________________
Name: Xxxx X. Xxxxx
______________________________
Title: Sr. Vice President
_____________________________
Date: 7/27/01
______________________________
PURCHASER:
QUESTCOR PHARMACEUTICALS, INC.
By: /s/ XXXXXXX X. XXXXXXXXX
________________________________
Name: Xxxxxxx X. Xxxxxxxxx
______________________________
Title: CHAIRMAN, PRESIDENT and CEO
_____________________________
Date: July 27, 2001
______________________________
SCHEDULE 2.1(a)
TRADEMARKS
COUNTRY TRADEMARK REGISTRATION NUMBER REGISTRATION DATE
----------------- ------------- ----------------------- --------------------
United States ACTHAR GEL 2,255,322 June 22, 1999
Canada ACTHAR 36927 Xxxxxxx 00, 0000
Xxxxxxx ACTHAR 26021 Xxxxxxxx 0, 0000
Xxxx Xxxx XXXXXX 902/1952 Xxxx 00, 0000
Xxxxx ACTHAR 212482 November 27, 1983
Ireland ACTHAR 70434 August 2, 1987
Lebanon ACTHAR 49876 January 14, 1987
United Kingdom ACTHAR 693384 October 27, 1985
Uruguay ACTHAR 280287 September 19, 1985
Venezuela ACTHAR 136836 February 17, 1989
SCHEDULE 2.1(d)
LIST OF EQUIPMENT
PART NUMBER SAP NUMBER DESCRIPTION
----------------------------------------------------------------------
L-1629 10004508 MOD I DRUM ROLLER
--------------- -------------- -------------------------------
L-2154 10004516 NORTH CENTRIFUGE
--------------- -------------- -------------------------------
L-2397 10004520 GELATIN BULK CAN
--------------- -------------- -------------------------------
L-2399 N/A GELATIN BULK CAN
--------------- -------------- -------------------------------
L-2400 N/A GELATIN BULK CAN
--------------- -------------- -------------------------------
L-2401 N/A GELATIN BULK CAN
--------------- -------------- -------------------------------
NC-2847 10004919 MOD I RESIN COLUMN
--------------- -------------- -------------------------------
NC-2848 10004920 MOD IC GEL BOMB
--------------- -------------- -------------------------------
NC-2849 10004921 PHENOL HOOD
--------------- -------------- -------------------------------
LM-4029 N/A MOD IC POTENTIATION TK
--------------- -------------- -------------------------------
L-4066 10004535 AAAP OVEN AND TRAYS
--------------- -------------- -------------------------------
L-4092 10004536 SOUTH CENTRIFUGE
--------------- -------------- -------------------------------
L-4244 10004550 MOD I RECON POT
--------------- -------------- -------------------------------
K-4490 N/A MILLIPORE CART. HOUSING
--------------- -------------- -------------------------------
L-5750 10004599 TWIN SHELL V BLENDER
--------------- -------------- -------------------------------
L-5912 10004604 WILEY MILL
--------------- -------------- -------------------------------
L-6125 10004612 FITZMILL COMMINUTOR
--------------- -------------- -------------------------------
L-6211 N/A MOD I DRUM
--------------- -------------- -------------------------------
L-6370 10009065 32% GEL TANK
--------------- -------------- -------------------------------
L-6511 10006334 18" XXXXXXX FUNNEL
--------------- -------------- -------------------------------
L-6780 10006335 AAAP G/L BLOW TANK
--------------- -------------- -------------------------------
L-6782 10004057 AAAP 80 GAL. G/L POT
--------------- -------------- -------------------------------
K-7650 10004490 AAAP EXTRACTION TANK
--------------- -------------- -------------------------------
K-7652 10004492 AAAP PRECIPITATION TANK
--------------- -------------- -------------------------------
L-8224 10006558 100 GAL SS POT
--------------- -------------- -------------------------------
L-8269 N/A SS POT
--------------- -------------- -------------------------------
N/A N/A MOD IC RECON AGITATOR (2)
--------------- -------------- -------------------------------
N/A N/A MOD IC RECON VESSEL
--------------- -------------- -------------------------------
N/A N/A MOD IC GLASS FILTER #1
--------------- -------------- -------------------------------
N/A N/A MOD IC GLASS FILTER #2
--------------- -------------- -------------------------------
N/A N/A MISC. EQUIPMENT
--------------- -------------- -------------------------------
L-911C N/A UTENSIL CART
--------------- -------------- -------------------------------
N/A N/A MOD 1 BOMB HEADER
--------------- -------------- -------------------------------
N/A N/A AIR/NITROGEN FILTER
--------------- -------------- -------------------------------
NC-5262 N/A ORION 310 PH METER
--------------- -------------- -------------------------------
L-4143 N/A BOMB FREEZER
--------------- -------------- -------------------------------
N/A N/A BOWL STAND FOR CENTRIFUGE
--------------- -------------- -------------------------------
NC-5735 N/A PUMP
--------------- -------------- -------------------------------
NC-3344 10004932 PUMP
--------------- -------------- -------------------------------
L-9119 D N/A POT
----------------------------------------------------------------------
SCHEDULE 2.1(d) (CONT.)
PART NUMBER SAP NUMBER DESCRIPTION
----------------------------------------------------------------------
L-9119 E N/A POT
--------------- -------------- -------------------------------
X-0000 X X/X POT
--------------- -------------- -------------------------------
L-9119 (3) N/A POT
--------------- -------------- -------------------------------
L-6965 10004669 SCALE 0-200KG
--------------- -------------- -------------------------------
NC-3366 N/A SCALE
--------------- -------------- -------------------------------
N/A N/A TABLE
--------------- -------------- -------------------------------
N/A N/A 2 GLASS BOTTLES
--------------- -------------- -------------------------------
N/A N/A 2 SS POTS
--------------- -------------- -------------------------------
N/A N/A 2 XXXXXXX XXXXXXX
----------------------------------------------------------------------
MATERIALS USED IN ACTHAR ASSAY
1) Rotary Mixer
2) Homogenizer, 2 Speed with Rheostat, Foot Pedal, Teflon Pestle
(Glas-Col)
3) Volustat Dispenser
4) Balance for weighing Adrenal Glands
5) Thermomax Microtiter Plate reader with Printer
MATERIALS USED IN HP ACTHAR MOD 1CL PILOT PREP
1) 1-Millipore 600 mL pressure system
2) 1-Millipore Swinnex -- 47 filter press
3) 1-Millipore AP 25 prefilter
4) 1-MF Millipore SS 3.0 (mu) membrane
5) 1-MF Millipore RA 1.2 (mu) membrane
6) 1-MF Millipore AA 0.8 (mu) membrane
7) 1-MF Millipore DA 0.65 (mu) membrane
8) 1-MF Millipore PH 0.30 (mu) membrane
9) 1-MF Millipore GS 0.22 (mu) membrane
10) 10 Millipore mesh spacers
SCHEDULE 2.1(e)
LIST OF INVENTORY
As of 06/14/01
UNIT OF RM OR TOTAL PRICE PER
PART# DESCRIPTION MEASURE WIP QUANTITY UNIT TOTAL VALUE
_______________________________________________________________________________________________________________________
277 GAUZE OXYCELLULOSE G RM * * *
_______________________________________________________________________________________________________________________
280 GELATIN KG RM * * *
_______________________________________________________________________________________________________________________
367 PORK PIT GLANDS KG RM * * *
_______________________________________________________________________________________________________________________
374 AAAP PWD MOD I G WIP * * *
_______________________________________________________________________________________________________________________
679 GELATIN, 32% SOLUTION W/1.0 PHENOL KG WIP * * *
_______________________________________________________________________________________________________________________
948 CYS L FREE BASE G RM * * *
_______________________________________________________________________________________________________________________
1979 HP ACTH MOD I POOL G WIP * * *
_______________________________________________________________________________________________________________________
3175 HPAG MOD ICL KG WIP * * *
_______________________________________________________________________________________________________________________
3879 LIQUIFIED PHENOL, USP L RM * * *
_______________________________________________________________________________________________________________________
17500 LABEL, ACTHAR GEL 80U 5ML EA RM * * *
_______________________________________________________________________________________________________________________
17565 CARTON HP ACTHAR GEL 80U 5ML EA RM * * *
_______________________________________________________________________________________________________________________
17620 INSERT, HP ACTHAR GEL EA RM * * *
_______________________________________________________________________________________________________________________
63760 BAG POLYETHYLENE DRUM LINER EA RM * * *
_______________________________________________________________________________________________________________________
65795 STR 13MM RED EA RM * * *
_______________________________________________________________________________________________________________________
67195 SEAL YELLOW 13MM EA RM * * *
_______________________________________________________________________________________________________________________
1350-01 HPAG 80U 5ML EA FIN * * *
_______________________________________________________________________________________________________________________
TOTAL *
_______________________________________________________________________________________________________________________
* Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
SCHEDULE 3.1
FORM OF NOTIFICATION LETTERS
[Questcor Pharmaceuticals, Inc. Letterhead]
July____, 2001
[ADDRESS TO FDA CONTACT PERSON FOR THIS NDA]
Re: NDA #08-372, H.P. Acthar Gel (corticotropin)
Dear [NAME OF FDA CONTACT PERSON]:
Reference is made to NDA 08-372 for H.P. Acthar Gel (corticotropin). In
accordance with 21 C.F.R. Section 314.72, the purpose of this letter is to
inform the Food and Drug Administration that ownership of, and all rights and
responsibilities for, the referenced NDA have been transferred to Questcor
Pharmaceuticals, Inc. (Questcor) from Aventis Pharmaceuticals, Inc. (Aventis),
effective July____, 2001.
Questcor is committed to complying with all agreements, promises and conditions
made by Aventis, as the former owner, and contained in the NDA. Aventis has
provided Questcor with a complete copy of the NDA.
If you have any questions, please contact me at [PHONE].
Sincerely,
[NAME]
Director of Scientific and Regulatory Affairs
SCHEDULE 3.1 (CONT.)
[Aventis Pharmaceuticals, Inc. Letterhead]
July __, 2001
[ADDRESS TO FDA CONTACT PERSON FOR THIS NDA]
Re: NDA #08-372, H.P. Acthar Gel (corticotropin)
Dear [NAME OF FDA CONTACT PERSON]:
Reference is made to NDA 08-372 for H.P. Acthar Gel (corticotropin). In
accordance with 21 C.F.R. Section 314.72, the purpose of this letter is to
inform the Food and Drug Administration that Aventis Pharmaceuticals, Inc. has
transferred all rights to the referenced NDA to Questcor Pharmaceuticals, Inc.
effective July __, 2001.
Please contact me at (000) 000-0000 if you have any questions.
Sincerely,
Xxxxxx X. Xxxx, Ph.D.
Director, CMC-US Drug Regulatory Affairs
cc: [NAME]
Director of Regulatory Affairs, Questcor Pharmaceuticals, Inc.
SCHEDULE 6.2
MANUFACTURING AND TESTING TRANSFER TIMETABLE AND PROJECT TEAM
July 20, 2001
Xxxxx Xxxxx
Senior Director, Business Development
Aventis Behring
0000 0xx Xxx
XXXX XX XXXXXXX, XX 00000-0000
Dear Xxxxx,
You had asked last week for a statement of intent from us regarding the site
transfer plan for Acthar Gel. The sequence of events, as contemplated at this
time, are as follows:
1. Immediately following the signing of the definitive agreement, QSC
will request a meeting with the FDA to discuss the proposed site
transfer plan for Acthar Gel.
2. Unless modified following the FDA meeting, QSC will first negotiate
and sign the contract manufacturer agreement with the vial filler,
the raw material manufacturer, and the assay testing laboratory.
3. Following the signing of the contract manufacturing agreements, it is
our intention to proceed initially with the assay transfer to the new
contract testing lab.
4. Concurrently with the assay transfer, we intend to begin the process
development work at the new vial filler.
5. The raw material extraction vendor will come to Kankakee and observe
the set-up of the current process, become familiar with all aspects of
the extraction procedures, and then Kankakee will be able to dismantle
the dedicated equipment and ready it for shipment.
Xxxxx, this site transfer process may be modified at a future point
depending on agreements between QSC and the FDA, or upon further discussion with
Aventis personnel. However, this represents our best description of the site
transfer process at this time.
