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EXHIBIT 10.2
INVENTORY PURCHASE AGREEMENT
THIS AGREEMENT is entered into as of June 30, 1997 by and between
XXXXX-XXXXXXX XXXXX PHARMACEUTICALS INC., a Delaware corporation with its
principal office at 000 Xxxxxx Xxxx, Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000 ("Seller")
and XXXXXX LABORATORIES, INC., a Nevada corporation with its principal office at
000 Xxxxxx Xxxxxx, Xxxxxx, Xxxxxxxxxx 00000 ("Purchaser").
R E C I T A L S
A. Seller is engaged in the business of distributing and selling the
Product (as defined below), a diltiazem based pharmaceutical product currently
marketed in the United States under the trademark Dilacor XR(R).
B. Until September 1, 1993, the manufacture and sale of the Product was
conducted on behalf of a partnership between Seller and an Affiliate (as defined
below) of Purchaser. The partnership transferred to Seller as of September 1,
1993 all of its rights with respect to the manufacture and sale of branded
versions of the Product (i.e., versions sold under a trademark) in the United
States of America and, as of April 27, 1993, all of its rights outside the
United States of America with respect to the manufacture and sale of branded and
generic (i.e., versions not sold under a trademark) versions of the Product.
Prior to the effective date of this Agreement, the partnership has continued in
existence for purposes of manufacturing and selling generic versions of the
Product in the United States of America.
C. Seller and Purchaser desire to enter into a series of transactions
pursuant to which, among other things: (i) Seller and an Affiliate of Purchaser
will terminate the partnership; (ii) an Affiliate of Seller will grant to
Purchaser an exclusive license of all of its rights to market, advertise,
promote, sell and distribute branded and generic versions of the Product in the
Territory (as defined below); (iii) Seller will arrange for the manufacture and
will supply such versions of the Product to Purchaser; and (iv) an Affiliate of
Seller will grant to Purchaser certain option rights with respect to acquisition
of such Affiliate's rights to the Products in the Territory (collectively, the
"Transaction").
D. As part of the Transaction, Seller desires to sell to Purchaser
certain inventory of and other assets relating to the Product, and Purchaser
desires to purchase said inventory and assets, all on the terms and subject to
the conditions contained in this Agreement.
A G R E E M E N T S
Therefore, for good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, the parties agree as follows:
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ARTICLE I
1.1 Definitions. As used herein, the following terms shall have the
meanings ascribed to them below:
"Act" shall mean the Federal Food, Drug and Cosmetic Act, as amended,
and the regulations promulgated under such Act.
"Affiliate" shall mean, when used with respect to a Person, any other
Person directly or indirectly controlling, controlled by, or under common
control with the subject Person; provided, however, that with respect to Seller,
only Xxxxx-Xxxxxxx Xxxxx Inc. ("RPR") and Persons directly or indirectly
controlled by RPR shall be an Affiliate of Seller for any provision of this
Agreement, or any of the Agreements contemplated hereby. For purposes of this
Agreement, "control" means the direct or indirect ownership of over 50% of the
outstanding voting securities of a Person, or the right to receive over 50% of
the profits or earnings of a Person.
"Consent Agreement" shall mean that certain Consent Agreement, dated as
of even date herewith, between Jago Research AG, Xxxxxx, Circa and RPR.
"FDA" shall mean the Food and Drug Administration of the United States
Department of Health and Human Services, or any successor agency thereto.
"FDA Standards" shall mean the Act, the establishment license
requirements and the Current Good Manufacturing Practice regulations of the FDA
applicable to the Product or, with respect to the Product, any manufacturing
facility at which the Product is manufactured by or for Seller, and all relevant
guidelines of the FDA.
"Jago License Agreement" shall mean that certain Diltiazem SR
Development and License Agreement, dated August 10, 1988, between RPR (formerly
known as Xxxxx Group Inc.) and Jago Research AG, as amended.
"License Agreement" means that certain License Agreement, dated as of
even date herewith, between Purchaser and Xxxxx Pharmaceutical Products Inc.
("RPPI").
"Licensed Trademark" means RPPI's Dilacor XR(R) trademark and the
goodwill associated therewith.
"Manufacturing Agreement" means that certain Manufacturing and Supply
Agreement, dated as of even date herewith, between Purchaser and Seller.
"Partnership Termination Agreement" means that certain Agreement
Regarding Partnership Termination, dated as of even date herewith, among
Purchaser, Circa Pharmaceuticals, Inc., BOL Inc., RPR, and Seller.
"Product" shall mean the pharmaceutical preparation consisting of
diltiazem formulated for extended release using the delivery technology licensed
under the Jago License Agreement and currently marketed by Seller in the U.S.A.
under the Dilacor XR(R) trademark.
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"Regulatory Approval" shall mean, with respect to any country in the
Territory, filing for and receipt of all governmental and regulatory
registrations and approvals (including, but not limited to, approvals of all
final Product labeling and all other data and documents of any nature contained
therein) required for the marketing and sale of the Product for the indication
for which it is being marketed in such country.
"Related Agreements" shall mean the Consent Agreement, License
Agreement, the Manufacturing Agreement and the Partnership Termination
Agreement.
"Reserved Countries" shall mean New Zealand, the Republic of Korea and
North Korea.
"Territory" shall mean the entire world, excluding the Reserved
Countries.
ARTICLE II
Purchase and Sale of Assets
2.1 Purchase and Sale of Assets. Seller does hereby sell, transfer,
convey, assign and deliver to Purchaser (subject to Seller's rights pursuant to
Section 6.8), and Purchaser hereby purchases and accepts, all of the Purchased
Assets (as defined below). The Purchased Assets shall be sold to Purchaser free
and clear of any liens, title claims, encumbrances or security interests.
2.2 Enumeration of Purchased Assets. The "Purchased Assets" consist of
the following items and no others:
(a) Inventory. All of Seller's finished, packaged inventory
(including samples) of the Product existing as of the date hereof which have an
expiration date occurring on or after June 30, 1998 (or May 1, 1998, in the case
of samples) and are in any of Seller's distribution centers or are in transit
from the site of manufacturing to such distribution centers, excluding any of
such Products held in quarantine and also excluding samples in the possession or
control of Seller's sales representatives (collectively, the "Inventory");
(b) Customer and Other Information. Originals or duplicate copies
of all customer lists, customer records and information, and books and records
held by Seller on the date hereof exclusively relating to the Purchased Assets
or the marketing, advertising, promotion, sale and distribution of the Product
in the Territory;
(c) Contracts. To the extent assignable by Seller, all of the
contracts listed on Exhibit 2.2(c);
(d) Sales Literature. All sales and promotional materials and
advertising literature currently approved for use in the Territory and held by
Seller in inventory on the date hereof relating exclusively to Product,
excluding sales and promotional materials and advertising literature in the
possession or control of Seller's sales representatives; and
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(e) The Regulatory Approvals listed on Exhibit 2.2(e), attached
hereto; provided, however, said Regulatory Approvals will be sold, transferred,
conveyed and delivered to Purchaser as provided in Section 6.13 hereof.
2.3 Excluded Assets. Notwithstanding anything to the contrary contained
herein, the Purchased Assets shall not include, and the Seller shall retain all
of its rights, title and interest in and to, all assets, properties or rights of
Seller other than those specifically enumerated as Purchased Assets in Section
2.2 (the "Excluded Assets"). Without limiting the generality of the foregoing,
the Purchased Assets shall not include (i) any right, title or interest in the
Licensed Trademark, with Purchaser's rights with respect thereto being limited
to those granted under the License Agreement; (ii) any right, title or interest
in the trade dress used by Seller and its Affiliates with respect to the
Product; (iii) any accounts receivable or other right to receive payment arising
out of or relating to Product shipped by Seller on or before June 30, 1997
except as provided in Section 6.4; or (iv) any right, title or interest in
Seller's corporate name, service xxxx or logo or NDC numbers used with respect
to the Product except as provided in Section 6.7.
2.4 Transition Arrangements. To facilitate the transfer to Purchaser of
the sale and distribution in the United States of America of the Product as
contemplated by the Transaction, Seller will provide to Purchaser, post-Closing,
certain services relating to certain Managed Care Contracts as set forth in
Section 6.12 and certain other services on a transition basis as set forth in
Exhibit 2.4.
ARTICLE III
Assumption of Liabilities
3.1 Assumption of Liabilities. Subject to the terms and conditions of
this Agreement, as of the date hereof, the Purchaser shall assume, and shall be
solely and exclusively liable with respect to, and shall pay, perform, discharge
and satisfy when due, only those liabilities of the Seller which are
specifically enumerated below (collectively, the "Assumed Liabilities"):
(a) all liabilities of the Seller under any portion of any contract
included in the Purchased Assets which according to such contract relate to
periods after the date hereof and are to be paid, performed, discharged or
satisfied after the date hereof; provided, however the Seller shall retain the
balance of the liabilities under such contracts including without limitation,
all accounts payable as of the date hereof;
(b) all liabilities for damages to third parties or their property
arising out of the sale of the Inventory after the date hereof; provided,
however, that Purchaser shall not assume, and Seller shall retain, any such
liabilities for any damages attributable to Products manufactured prior to the
date hereof that, as of the date hereof, were adulterated or misbranded within
the meaning of the Act or otherwise would fail to conform to the representations
and warranties set forth in Sections 3.1(a) and 3.1(b) of the Manufacturing
Agreement had such Inventory been manufactured and delivered thereunder;
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(c) all liabilities in respect of Product warranties and returned
Products provided, however, that:
(i) in respect of such liabilities attributable to defective
Products that were manufactured prior to the date hereof, the Seller shall
reimburse the Purchaser within thirty (30) days of being invoiced by the
Purchaser for the out-of-pocket costs of replacing such Products or the rebate
or credit issued in lieu of such replacement; and
(ii) in respect of such liabilities attributable to Products
that are returned in the ordinary course of business and in accordance with
Seller's returned goods policy, a copy of which is attached hereto as Exhibit
3.1(c)(ii), (without solicitation or inducement by Purchaser) and that were sold
by Seller prior to the date hereof, are not defective and have expired, the
Seller shall reimburse the Purchaser with thirty (30) days of being invoiced by
the Purchaser for the out-of-pocket costs of replacing such Products or the
rebate or credit issued in lieu of such replacement; provided, however, that
where such returned Products are from a lot a portion of which was sold by the
Seller and a portion of which was sold by the Purchaser, the Seller shall
reimburse the Purchaser as specified above pro rata based on the proportion of
such lot sold by the Seller as determined by the Closing Inventory Statement
(defined below). The Purchaser will provide the Seller with copies of such
backup documentation as is reasonably satisfactory to the Seller to support
Purchaser's reimbursement claims under this Section 3.1(c);
(d) all liabilities in respect of chargebacks, rebates or discounts
under the Managed Care Contracts (as defined below) and all governmental
chargebacks, rebates or discounts (including without limitation Medicaid
rebates) with respect to the Product (collectively, "Rebates"); provided,
however, that Purchaser shall not assume, and Seller shall retain, such
liabilities with respect to Rebates reflecting an Activity Date (as defined
below) (i) on or prior to the date hereof or (ii) after the date hereof but
prior to the thirty-first (31st) calendar day after the date hereof; provided,
further, however that the maximum liability of Seller under this clause (ii)
shall be $550,000. "Activity Date" as used herein shall mean, in the case of all
Rebates paid for the benefit of a customer (other than a wholesaler) that takes
possession of the Product, the date of sale of the Product by a wholesaler to
such customer, and in the case of all Rebates paid for the benefit of a customer
that does not take possession of the Product, the date of dispensing of the
Product to the patient; and
(e) all liabilities (other than for Rebates, which are provided for
in Section 3.1(d)) in respect of the Product under each Managed Care Contract
arising in respect of the period during which Seller is administering such
Managed Care Contract on Purchaser's behalf pursuant to Section 6.12.
3.2 No Assumption of Liabilities. Except for the Assumed Liabilities
and Purchaser's other obligations under this Agreement and the Related
Agreements, Purchaser is not assuming and will not in any way be liable or
responsible for any liabilities, obligations or indebtedness of Seller, whether
relating to the Purchased Assets or otherwise, of any kind or nature whatsoever,
whether due or to become due, absolute or contingent, direct or indirect,
asserted or unasserted, including, without limitation, claims relating to
product defects, warranties and/or destruction of Products.
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ARTICLE IV
Purchase Price, Manner of Payment and Closing
4.1 Purchase Price. Subject to the adjustments set forth in this
Article III, the purchase price of the Purchased Assets shall equal:
(a) Twenty Million Dollars ($20,000,000.00); plus
(b) Seller's standard cost for the Inventory (the "Inventory
Value"), determined in accordance with Section 4.2 below, for which Seller's
good-faith estimate of the Inventory Value, based upon the most recent
ascertainable financial information, is $2,125,000.00 as of the date hereof (the
"Estimated Inventory Amount").
4.2 Determination of Inventory Value. The Inventory Value shall be
determined based on Seller's standard cost as set forth on Schedule 4.2
("Standard Costs") and a physical inventory of the Inventory as of the close of
business on June 30, 1997 conducted by Seller on July 1, 1997 (July 15, 1997 in
report of Inventory in Puerto Rico) (the "Closing Inventory"). A report of the
Closing Inventory (the "Closing Inventory Statement") shall be prepared by
Seller in accordance with generally accepted accounting principles ("GAAP")
applied in a manner consistent with the accounting principles applied in the
preparation of Seller's books and records and delivered to Purchaser not later
than thirty (30) days after the date hereof. Seller shall make available to
Purchaser and Purchaser's accountants its work papers with respect to the
Closing Inventory Statement.
4.3 Disputes Regarding Closing Inventory Statement. Disputes with
respect to the Closing Inventory Statement shall be dealt with as follows:
(a) Purchaser shall have thirty (30) days after receipt of the
Closing Inventory Statement (the "Dispute Period") to dispute any of the
elements of or amounts reflected on the Closing Inventory Statement (a
"Dispute"). If Purchaser does not give written notice of a Dispute within the
Dispute Period to Seller (a "Dispute Notice"), the Closing Inventory Statement
shall be deemed to have been accepted and agreed to by Purchaser in the form in
which it was delivered by Seller, and shall be final and binding upon the
parties hereto. If Purchaser has a Dispute, Purchaser shall give Seller a
Dispute Notice within the Dispute Period, setting forth in reasonable detail the
elements and amounts with which it disagrees. Within thirty (30) days after
delivery of such Dispute Notice, the parties hereto shall attempt to resolve
such Dispute and agree in writing upon the final content of the disputed Closing
Inventory Statement.
(b) If Purchaser and Seller are unable to resolve any Dispute
within the thirty (30) day period after Seller's receipt of a Dispute Notice,
the parties hereto shall select by mutual agreement a nationally recognized
certified public accounting firm who is not rendering (and during the preceding
two-year period has not rendered) services to either Seller or Purchase as to an
Affiliate of either, to serve as the arbitrating accountant (the "Arbitrating
Accountant") engaged as the arbitrator hereunder to settle such Dispute as soon
as practicable. The parties and the Arbitrating Account shall attempt in good
faith to resolve any Dispute by September 30, 1997. In connection
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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. Seller shall be entitled to withhold such
access unless the Arbitrating Accountant agrees to sign a confidentiality
agreement with Seller which shall obligate such accountant to hold the
information he receives by reason of such access in confidence, except for
disclosure to Seller and Purchaser of information necessary to establish the
accuracy of the Closing Inventory Report and to render an award resolving the
Dispute. 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. Seller and Purchaser shall each pay one-half of the fees and
expenses of the Arbitrating Accountant with respect to any Dispute.
4.4 Manner of Payment of the Purchase Price. At the Closing (as defined
below), Purchaser shall pay to Seller an amount equal to $22,125,000.00
(representing $20,000,000.00 plus the Estimated Inventory Amount) by wire
transfer to an account or accounts designated in writing by Seller. Following
the Closing, the parties shall determine the final Purchase Price, employing the
procedures and criteria set forth in Sections 4.2 and 4.3 above. If, based on
the Purchase Price as finally determined: (i) the Inventory Value exceeds the
Estimated Inventory Amount, Purchaser shall forthwith pay the excess to Seller
as additional consideration hereunder; or (ii) the Estimated Inventory Amount
exceeds the actual Inventory Value, Seller shall forthwith refund such excess to
Purchaser.
4.5 Time and Place of Closing. Except as contemplated by Section 6.13,
the transaction contemplated by this Agreement shall be consummated (the
"Closing") at 10:00 a.m. at the offices of X'Xxxxxx & Xxxxxx, 00 Xxxxx XxXxxxx,
Xxxxx 0000, Xxxxxxx, Xxxxxxxx, 00000 on the date hereof. The Closing shall be
deemed to be effective as of 11:59 p.m. on the date hereof at Chicago, Illinois.
4.6 Closing Deliveries. At the Closing, the parties shall execute and
deliver such bills of sale, assignments, documents of title, instruments of
assumption, closing certificates, and other documents as are reasonably required
in order to effectuate the consummation of the transaction contemplated hereby.
All documents to be delivered by a party shall be in form and substance
reasonably satisfactory to the other party.
ARTICLE V
Representations and Warranties
5.1 Purchaser's Representations and Warranties. Purchaser represents
and warrants to Seller as of the date hereof that:
(a) Organization. Purchaser is a corporation duly organized,
existing and in good standing, under the laws of the State of Nevada.
(b) Power, Authority and Enforceability. Purchaser has full
corporate power and authority to enter into and perform this Agreement, the
Related Agreements and all documents and instruments to be executed by Purchaser
pursuant to this Agreement (collectively, "Purchaser's
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Ancillary Documents"). This Agreement, the Related Agreements and Purchaser's
Ancillary Documents have been duly executed and delivered by duly authorized
officers of Purchaser. This Agreement, the Related Agreements and Purchaser's
Ancillary Documents are valid and binding obligations of Purchaser, enforceable
against Purchaser in accordance with their respective terms.
(c) Consents. Except for consents obtained on or prior to the date
hereof, no consent, authorization, order or approval of, or filing or
registration with, any governmental authority or other person is required for
the execution and delivery by Purchaser of this Agreement, the Related
Agreements and Purchaser's Ancillary Agreements, and the consummation by
Purchaser of the transaction contemplated by this Agreement, the Related
Agreements and Purchaser's Ancillary Documents.
(d) No Violation. Upon compliance by the parties with applicable
requirements of the Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, as
amended (the "HSR Act"), neither the execution and delivery of this Agreement,
the Related Agreements and Purchaser's Ancillary Documents by Purchaser, as the
case may be, nor the consummation by Purchaser of the transaction contemplated
hereby and thereby, will conflict with or result in a breach of any of the
terms, conditions or provisions of Purchaser's Certificate of Incorporation or
By-laws, or of any statute or administrative regulation, or of any order, writ,
injunction, judgment or decree of any court or governmental authority or of any
arbitration award or any agreement binding upon Purchaser.
(e) No Default. Purchaser is not a party to any unexpired,
undischarged or unsatisfied written or oral contract, agreement, indenture,
mortgage, debenture, note or other instrument under the terms of which
performance by Purchaser according to the terms of this Agreement and the
Related Agreements will be a default, or whereby timely performance by Purchaser
according to the terms of this Agreement and the Related Agreements may be
prohibited, prevented or delayed.
(f) Litigation. There is no action or proceeding pending or, to
personal knowledge of Purchaser's executive officers, threatened against
Purchaser or any of its Affiliates before any court, arbitrator, administrative
agency or other tribunal which could impact upon Purchaser's right, power and
authority to enter into this Agreement and the Related Agreements, to receive
the rights granted to Purchaser hereunder and thereunder, or to otherwise carry
out its obligations hereunder, or which might have a material adverse effect on
Purchaser's business or condition, financial or otherwise.
5.2 Seller's Representations and Warranties. Seller represents and
warrants to Purchaser as of the date hereof that:
(a) Organization. Each of Seller and each of its Affiliates that is
a party to this Agreement or any Related Agreement is a corporation duly
organized, existing and in good standing, under the laws of the State of its
incorporation. Seller has all necessary corporate power and authority to market
and sell the Product in the Territory as such activities and now being
conducted.
(b) Power, Authority and Enforceability. Seller has full corporate
power and authority to enter into and perform this Agreement, the Related
Agreements and all documents and instruments to be executed by Seller pursuant
to this Agreement (collectively, "Seller's Ancillary
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Documents"). This Agreement, the Related Agreements and Seller's Ancillary
Documents have been duly executed and delivered by duly authorized officers of
Seller and/or one of its Affiliates. This Agreement, the Related Agreements and
Seller's Ancillary Documents are valid and binding obligations of Seller and/or
such Affiliates, enforceable against each of them in accordance with their
respective terms.
(c) No Consent. Except for consents obtained on or prior to the date
hereof and except as set forth on Schedule 5.2(c), no consent, authorization,
order or approval of, or filing or registration with, any governmental authority
or other person is required for the execution and delivery of this Agreement,
the Related Agreements and Seller's Ancillary Documents and the consummation by
Seller and its Affiliates of the transaction contemplated by this Agreement, the
Related Agreements and Seller's Ancillary Documents
(d) No Violation. Upon compliance by the parties with applicable
requirements of the HSR Act, neither the execution and delivery of this
Agreement, the Related Agreements and Seller's Ancillary Documents, as the case
may be, nor the consummation by Seller or its Affiliates of the transaction
contemplated hereby and thereby, will conflict with or result in a breach of any
of the terms, conditions or provisions of Seller's or its Affiliate's Articles
of Incorporation or By-laws, or of any statute or administrative regulation, or
of any order, writ, injunction, judgment or decree of any court or any
governmental authority or of any arbitration award or any material agreement
binding upon Seller or its Affiliates.
(e) Title to Purchased Assets. Seller has good and marketable title to
or, as the case may be, a valid contract right in, and the corporate power to
sell, the Purchased Assets, free and clear of any liens, title claims,
encumbrances and security interests. No unreleased mortgage, trust deed, chattel
mortgage, security agreement, financing statement or other instrument
encumbering any of the Purchased Assets has been recorded, filed, executed or
delivered.
(f) Compliance with Laws--FDA.
(i) Seller is in substantial compliance with all applicable
provisions of the Regulatory Approvals for the Product in the Territory and,
insofar as the Product is concerned, all applicable provisions of 21 U.S.C.
Sections 355, and 21 C.F.R. Parts 314 et. seq.
(ii) Seller is in compliance with all applicable registration and
listing requirements set forth in 21 U.S.C. Section 360 and 21 C.F.R. Part 207
applicable to the Inventory.
(iii) With respect to the Inventory, all manufacturing operations
conducted by or, to the knowledge of the Seller, for the benefit of the Seller
and its Affiliates have been and are being conducted in substantial compliance
with FDA Standards.
(iv) Seller has made available to Purchaser copies of any and all
Form 483s, Warning Letters and Notice of Violation Letters with respect to the
Product received by Seller from the FDA within the last three years that
indicate or suggest lack of compliance with the FDA Standards with respect to
the Product.
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(v) Except as disclosed to Purchaser, neither the Seller nor any of
its Affiliates has received any written notice that the FDA has commenced, or
threatened to initiate, any action to withdraw the Product's Regulatory Approval
or request the recall of the Product.
(vii) The Inventory is not adulterated or misbranded within the
meaning of 21 U.S.C. Sections 301c et. seq.
(g) Litigation. Except as set forth on Schedule 5.2(g), there is no
litigation or proceeding, in law or in equity, before any court, arbitrator,
administrative agency or other tribunal and there are no proceedings or
governmental investigations before any commission or other administrative
authority, pending, or, to the personal knowledge of Seller's executive
officers, threatened, against Seller or its Affiliates, with respect to the
Product or the consummation of the transaction contemplated hereby, the Licensed
Trademark, the rights under the Jago License Agreement, or the use, ownership or
sale of the Purchased Assets by Seller prior to the Closing or the intended
ownership or sale by Purchaser after the Closing as contemplated by the
Transaction.
(h) Warranties. Except as set forth on Schedule 5.2(h), and in this
Agreement, the Related Agreements and the agreements set forth on Exhibit 6.12,
Seller has not made any oral or written warranties with respect to the quality
or absence of defects in the Product sold in the Territory which are in force as
of the date hereof. Except as set forth on Schedule 5.2(h), there are no
material claims pending or, to the personal knowledge Seller's executive
officers, threatened, against Seller or any of its Affiliates with respect to
the quality of or absence of defects in the Product.
(i) Interim Conduct of Business. Except as otherwise contemplated by
this Agreement, since April 1, 1997, Seller has not:
(i) sold or agreed to sell or otherwise disposed of the Product
except for sales in the usual and ordinary course of business in accordance with
the Seller's past practices;
(ii) waived any material right arising out of the conduct of, or
with respect to, its business of selling and distributing the Products; or
(iii) without limitation by the enumeration of any of the
foregoing, entered into any transaction with respect to the Product other than
in the usual and ordinary course of business in accordance with past practices
with respect to marketing, selling and distributing the Products.
Notwithstanding the foregoing, the Company shall not be deemed to have breached
the terms of this Section 5.2(i) by entering into this Agreement and the Related
Agreements or by consummating the transactions contemplated hereby and thereby.
(j) Inventory. All the Inventory consists of items of a quantity that
will be useable and/or salable in the normal course of business, based on past
practice.
(k) Contracts. Schedule 5.2(k) correctly and completely lists and
describes all material contracts, and agreements in the Territory to which
Seller is a party and which relate to the sale of
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the Products that are: agreements with managed care providers and similar
agreements; license agreements; and clinical study agreements. As to the
contracts, leases and other instruments referred to in Sections 2.2(c) and 6.12:
(i) such contracts, leases and other instruments are in full force and binding
upon Seller, and to Seller's knowledge, the other parties thereto; (ii) no
default by Seller has occurred thereunder and (iii) to Seller's knowledge, no
default by the other contracting parties has occurred thereunder. No event,
occurrence or condition exists which, with the lapse of time, the giving of
notice, or both, or the happening of any further event or condition, would
become a default by Seller thereunder.
(l) Intellectual Property Rights.
Except as set forth in Schedule 5.2(l):
(i) Xxxxx Pharmaceutical Products Inc. ("RPPI") has the right,
power and authority, including all necessary right, title and interest to the
Royalty Bearing Product Rights, in order to xxxxx Xxxxxx the licenses and
purchase options set forth in Section 2.1 of the License Agreement;
(ii) RPPI has all right, title and interest in and to the Licensed
Trademark in the jurisdictions in the Territory in which RPPI or an Affiliate
has a trademark registration with respect to said xxxx, as set forth in Schedule
5.2(l)(ii), free and clear of any liens, title claims, encumbrances or security
interests; and
(iii) To Seller's knowledge, the manufacture, use and sale of the
Product in the Territory does not infringe any patents, patent rights, patent
applications, trade secret or other proprietary or property rights of any third
parties.
(m) Approval. The Product is approved by the FDA for the indications
set forth in its approved labeling, a copy of which is attached hereto as
Exhibit 5.2 (m).
5.3 Where a representation or warranty contained in this Article V is
stated to be to a party's knowledge, this shall mean to the actual knowledge of
all of the officers and appropriate key personnel of such party, after
reasonable inquiry.
5.4 All exceptions noted in the applicable schedules to this Agreement
shall be numbered to correspond to the applicable Sections of the Agreement to
which such exception refers; provided, however, that any disclosure set forth on
any particular schedule shall be deemed disclosed in reference to all applicable
schedules.
5.5 The provisions of this Article V shall survive both the Closing and the
expiration or sooner termination of the term of this Agreement for a period of
twelve (12) months.
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ARTICLE VI
Post-Closing Agreements
6.1 Post-Closing Agreements. From and after the Closing, the parties shall
have the respective rights and obligations which are set forth in the remainder
of this Article VI, all of which shall survive both the Closing and the
expiration or sooner termination of this Agreement.
6.2 Inspection of Records. Seller and Purchaser shall each retain and make
any books and records exclusively relating to the marketing, sale or
distribution of Products in the Territory ("Books and Records") in their
possession available for inspection by the other party, or by its duly
accredited representatives, for reasonable business purposes at all reasonable
times during normal business hours and at their normal location, for a seven (7)
year period after the date hereof. As used in this Section 6.2, the right of
inspection includes the right reasonably to make extracts or copies. The
representatives of a party inspecting the records of the other party shall be
reasonably satisfactory to the other party and shall first sign a
confidentiality agreement with the other party which shall obligate such
representative to hold the information he receives by reason of such access in
confidence, except for disclosure to such party of information reasonably
required by the other party to accomplish the purposes of the Transaction.
6.3 Certain Assignments. Any other provision of this Agreement to the
contrary notwithstanding, this Agreement shall not constitute an agreement to
transfer or assign, or a transfer or assignment of, any claim, contract, lease,
commitment, sales order or purchase order, or any benefit arising thereunder or
resulting therefrom, if an attempt at transfer or assignment thereof without the
consent required or necessary for such assignment, would constitute a breach
thereof or in any way adversely affect the rights of Purchaser or Seller
thereunder. If such a consent or agreement to transfer or assign is not obtained
for any reason, Purchaser and Seller shall cooperate in any arrangement mutually
agreed in writing to provide Purchaser the benefits under such claim, contract,
lease, commitment or order.
6.4 Excess Sales Make-Up Payment. Within forty-five (45) days after the
date hereof, Seller shall provide Purchaser with a written report, specifying
the Net Sales (as defined below) of the Product in the United States of America
by month for the three month period ended June 30, 1997. To the extent that such
Net Sales during any calendar month during such three month period exceeds the
"Average Monthly Sales Amount" (as defined below), Seller shall forthwith pay to
Purchaser the amount by which such monthly Net Sales exceeds the Average Monthly
Sales Amount ("Excess Sales"), minus (i) Seller's Standard Cost to manufacture
the Products to which the Excess Sales relate, and (ii) the proportionate amount
of any royalty payments attributable to such Excess Sales that are payable to
Circa Pharmaceuticals, Inc. pursuant to Section 7 of the Partnership Termination
Agreement. For purposes hereof, (i) the term "Average Monthly Sales" shall mean
the monthly average of Net Sales of the Product by Seller in the United States
of America for the twelve calendar months preceding the date hereof, and (ii)
the term "Net Sales" shall have the same meaning ascribed to such term in the
Partnership Termination Agreement.
6.5 Sales and Transfer Taxes and Fees. Purchaser shall pay when due all
sales taxes and/or use taxes, recording fees, personal property title
application fees, patent and trademark
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assignment registration fees and all other taxes and fees on transfer of the
Purchased Assets and the Assumed Liabilities arising by virtue of the sale of
the Purchased Assets to Purchaser, regardless of whether the liability for said
taxes or fees is imposed by law upon Seller or upon Purchaser.
6.6 Further Assurances. The parties shall execute such further documents,
and perform such further acts, as may be reasonably necessary to transfer and
convey the Purchased Assets to Purchaser, on the terms herein contained, and to
otherwise comply with the terms of this Agreement and consummate the transaction
contemplated hereby.
6.7 Use of RPR Name; Trade Dress, and NDC Numbers.
(a) The Seller hereby grants to the Purchaser effective immediately
after the Closing, the royalty-free nontransferable right and non-exclusive
license to use for a reasonable time (not to exceed six (6) months after the
Closing) Seller's corporate names, service xxxx or logo (the "Marks") and the
trade dress of the Product as of the date of this Agreement ("Trade Dress") in
the same manner as they are presently used on all labels and packaging for the
Product, in the ordinary course of the business. The Purchaser agrees that the
nature and quality of any Product sold under such Marks and Trade Dress shall
conform substantially to the Seller's past practices, standards and
specifications. If the Seller at any time during the Purchaser's use of such
materials reasonably determine that the requirements of the foregoing provision
have not been complied in all material respects, Seller shall have the right to
terminate the right and license granted under this Section 6.7 by giving written
notice of such breach to the Purchaser and the opportunity for 30 days to cure
such breach. In addition, the Purchaser shall indemnify and hold the Seller
harmless for any Damages (as hereinafter defined) to the Seller arising from the
right and license granted hereunder.
(b) Following the Closing the Purchaser will use commercially
reasonable efforts to develop and have approved, if necessary, its own labels
and packaging for the Product so as to eliminate its use of the Marks and Trade
Dress, to change the manufacturer code portion of the NDC number for the Product
to a Purchaser manufacturer code, and to remove the Seller's manufacturer code
from all Product labels as promptly as possible and in any event within six (6)
months.
6.8 Reconveyance of Purchased Assets. Following expiration or termination
of the License Agreement at a time when Purchaser shall not have theretofore
exercised the Purchase Option (as defined therein), the Purchaser shall sell,
convey, assign and deliver to the Seller for no additional consideration, all
Regulatory Approvals, books and records and contracts or agreements necessary
for the marketing, advertising, promotion, sale or distribution of the Royalty
Bearing Products (as defined in the License Agreement) in the Territory and held
by the Purchaser or any Affiliate of the Purchaser so long as the Seller assumes
all the liabilities under such contracts and agreements from and after the
transfer date. In the event the Purchaser transfers any of such Regulatory
Approvals, books and records or contracts or agreements after the Closing, such
transfer shall be subject to this Section 6.8. The Purchaser shall take such
actions and execute and deliver such documents and instruments as the Seller may
reasonably request to effectuate the provisions of this Section 6.8.
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6.9 Reference Rights. Following the Closing and in perpetuity the Purchaser
shall permit the Seller to reference (and upon request shall so advise the FDA
or other applicable regulatory authority), and upon Seller's request shall
accord Seller access to, and copies of, all data contained in the Purchaser's
Regulatory Approvals for the Royalty Bearing Products (as defined in the License
Agreement) to the extent necessary to permit Seller to market and distribute the
Royalty Bearing Products outside the Territory and to obtain and maintain
Regulatory Approvals to market and distribute the Royalty Bearing Products
outside the Territory. Purchaser shall promptly advise Seller of any changes
made in any Royalty Bearing Product Regulatory Approval that could reasonably be
expected to have an impact on such Regulatory Approvals of Seller outside the
Territory.
6.10 Medicaid Rebates. Purchaser shall calculate, prepare and deliver to
Seller in a timely manner all data and information relating to the Product
including, without limitation pricing data, average manufacturers price data and
best price data, required to be submitted under Seller's agreement with the
Health Care Financing Administration ("HCFA") regarding the payment of Medicaid
rebates (the "Medical Rebate Agreement"). Purchaser shall provide all such data
to Seller at least ten (10) days prior to any date upon which Seller is
obligated to submit the relevant data to HCFA or any state Medicaid agency and
shall be solely liable for any fines or penalties imposed on Sellers as a result
any delay by Purchaser in providing such data to Seller. Purchaser shall
maintain books and records with respect to all data provided to Seller hereunder
sufficient to meet the requirements of the Medicaid Rebate Agreement and all
applicable laws with respect to the payment of Medicaid rebates. Purchaser shall
have full responsibility for initiating and resolving any disputes with HCFA or
any state Medicaid agency with respect to the payment of Medicaid rebates for
any Product for which Purchaser has liability.
6.11 MMD Lawsuit.
(a) Purchaser agrees to be bound by and shall fully comply with all
orders, judgments or decrees issued at any time, whether previously or in the
future, by any court in the lawsuit Xxxxx-Xxxxxxx Xxxxx Pharmaceuticals Inc. v.
Xxxxxx Xxxxxxx Dow, Inc., Nos. 93-0144-CV-W-1 and 93-0149-CV-W-1 (W.D. Mo),
including any appeals or remands in connection therewith and any settlements or
other agreements entered into by the parties to such lawsuit in connection
therewith (the "MMD Lawsuit").
(b) Seller shall consult with Purchaser regarding the management of
the MMD Lawsuit and keep Purchaser informed of material developments in the MMD
Lawsuit; provided, however, that this shall not in any way limit Seller's right,
in its sole discretion, to make all final decisions with respect to the MMD
Lawsuit. Upon request, Seller shall cooperate with Purchaser in arranging for
Purchaser to be substituted for Seller as a party to the MMD Lawsuit, and upon
such substitution, and the full and complete removal and release of Seller as a
party to the MMD Lawsuit, Seller will transfer full and complete control and
responsibility for the management of the MMD Lawsuit to Purchaser.
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6.12 Managed Care Contracts.
(a) On behalf of Purchaser, Seller shall use commercially reasonable
efforts consistent with its own policies and practices to maintain the Product
on the contracts listed on Exhibit 6.12 (the "Managed Care Contracts"), under
and in accordance with the terms of the Managed Care Contracts, and to
administer the Managed Care Contracts with respect to the Product until, in the
case of each Managed Care Contract, the earliest of (1) the expiration,
termination or first renewal date of such contract, (2) deletion of the Product
therefrom pursuant to Section 6.12(b), or (3) December 31, 1997. In exchange for
Seller's performing the services provided for in this Section 6.12 with respect
to the Managed Care Contracts, Purchaser shall assume certain liabilities under
the Managed Care Contracts, as set forth in Sections 3.1(d) and (e), and shall
reimburse Seller for all amounts disbursed by Seller in discharging such assumed
liabilities on Purchaser's behalf; and
(b) During the period Seller is administering a Managed Care Contract
on Purchaser's behalf pursuant to Section 6.12(a), Seller will not offer or
enter into any new contractual terms or arrangements thereunder with respect to
the Product. Upon written notice from Purchaser to Seller that Purchaser has
entered into a replacement contract with respect to the Product with the other
contracting party of that Managed Care Contract, Seller will promptly take all
necessary steps to delete the Product from such Managed Care Contract.
6.13 Purchaser's Regulatory Approvals. Purchaser shall use commercially
reasonable efforts to develop and establish the capability to administer and
manage the Regulatory Approvals listed on Exhibit 2.2(e) not later than December
31, 1997. At such time as Purchaser has done so, but in no event later than
December 31, 1997, Seller shall sell, transfer, convey, assign and deliver to
Purchaser (subject to Seller's rights pursuant to Section 6.8), and Purchaser
shall purchase and accept, the Regulatory Approvals listed on Exhibit 2.2(e) at
no additional charge (the purchase price for such Regulatory Approvals being
included in the consideration set forth in Section 4.1(a)).
6.14 NDA Administration Period. Beginning on the date hereof and continuing
during the period ending upon the transfer of the Regulatory Approvals listed on
Exhibit 2.2(e) to Purchaser as provided for in Section 6.13 (the "NDA
Administration Period"), Seller shall maintain and administer the Regulatory
Approvals listed on Exhibit 2.2(e) on Purchaser's behalf. In order to enable
Seller to perform such services, and as an inducement for Seller to do so,
Purchaser shall: (i) comply fully with all laws, rules and regulation in the
Territory applicable to such Regulatory Approvals; (ii) upon request, provide
Seller, promptly and in time for Seller to comply with all requirements
applicable to such Regulatory Approvals, with all information and materials
necessary or useful to Seller in performing such services, including without
limitation four (4) copies of the final form of all advertising and promotional
materials prior to their use; (iii) cooperate with Seller as necessary or useful
in Seller's performance of such services, including without limitation, in
conducting any investigations concerning, and in responding to, all inquiries,
notices or other communications from the FDA or any other governmental authority
relating to such Regulatory Approvals; (iv) refrain from using any Product
labels, labeling, information or material, or making any claim, in connection
with the advertising, promotion, marketing or sale of the Product until such
labels, labeling, information, material or claim has been approved by Seller in
accordance with the terms of Section 6.15 below; and (v) pay all FDA user fees
due with respect to the Product or the Regulatory Approvals for any periods
after the date hereof.
6.15 Communications. During the NDA Administration Period, Purchaser shall
provide to a designated employee of Seller all labels, labeling,
information, materials or claims that
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Purchaser intends to use or make in the marketing, distribution,
advertising or promotion of the Product (excluding only items described in
Section 2.2(d) above) for review by Seller in accordance with Seller's internal
policies and procedures for the review and approval of advertising and
promotional material. Seller shall review each such item in accordance with such
internal policies and procedures and advise Purchaser whether it has approved or
disapproved such item. Purchaser shall bear the responsibility of modifying and
resubmitting for review in accordance with this Section 6.15 any disapproved
item that Seller continues to want to use. Purchaser shall comply with and abide
by all of Seller's internal policies and procedures for the review and approval
of advertising and promotional material, and it shall be the responsibility of
Purchaser's marketing personnel to manage the review and approval process for
all items described herein.
6.16 Documents. During the NDA Administration Period, Seller shall notify
Purchaser of, and (to the extent applicable) provide Purchaser copies of, all
notices and letters from, and communications and meetings with, the FDA or any
comparable regulatory authority with respect to any of the Regulatory Approvals
listed on Exhibit 2.2(e). Such notice shall be given promptly, taking into
account the nature and substance of the applicable notice, letter or
communications. Seller shall consult with Purchaser in preparing all letters,
responses and communications to the FDA and such other regulatory authorities
with respect to the Product or the Regulatory Approvals and shall permit
Purchaser to attend any such meetings with the FDA or such other regulatory
authorities.
6.17 SEC Filing. Upon reasonable request, Seller shall make available to
Purchaser such estimated, historical sales, cost of sales, and other operating
expense information as Seller possesses in its books and records relating to the
Product and periods prior to the Closing if and to the extent Purchaser is
required to file or disclose such information to comply with any and all of
Purchaser's reporting requirements under the Securities Exchange Act of 1934, as
amended (the "34 Act") with respect to the Transaction. Seller will not
knowingly provide any false information pursuant to this Section 6.17, but
otherwise Seller shall have no responsibility for the accuracy or completeness
of any information provided pursuant to this Section 6.17, and Purchaser will
not attribute such information to Seller or specify Seller as the source thereof
in any such '34 Act filing (or otherwise), without Seller's written consent.
ARTICLE VII
Indemnification
7.1 General. From and after the Closing, the parties shall indemnify each
other as provided in this Article VII. As used in this Agreement, the term
"Damages" shall mean all liabilities, demands, claims, actions or causes of
action, regulatory, legislative or judicial proceedings or investigations,
assessments, levies, losses, fines, penalties, damages, costs and expenses,
including, without limitation, reasonable attorneys', accountants',
investigators', and experts' fees and expenses, sustained or incurred in
connection with the defense or investigation of any such claim.
7.2 Indemnification Obligations of Seller. Seller shall defend, indemnify,
save and keep harmless Purchaser and its Affiliates and their respective
successors and permitted assigns against and from all Damages sustained or
incurred by any of them resulting from or arising out of or by virtue of:
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(a) Representations. Any material inaccuracy in or material breach of
any representation and warranty made by Seller in this Agreement or in any
Seller's Ancillary Document; provided, however, that (i) Seller shall not have
any liability under this Section 7.2(a) unless and until, and then only to the
extent, the aggregate, cumulative amount of such Damages exceeds $2,000,000 (the
"Indemnity Deductible Amount") and (ii) in no event shall the aggregate,
cumulative liability of Seller for Damages under this Section 7.2(a) exceeds
$25,000,000 (the "Indemnity Cap Amount");
(b) Certain Covenants. Any material breach by Seller of, or material
failure by Seller to comply with, any of its respective covenants or obligations
that are a part of its responsibility for the Assumed Liabilities prior to the
Closing;
(c) MMD Lawsuit. All expenses incurred by Purchaser as a result of its
obligation to comply with the covenant set forth in Section 6.11(a) hereof other
than (i) the expense of pre-clearing with the FDA advertising claims as provided
for in the District Court orders in the MMD Lawsuit, and (ii) any and all costs,
expenses and liabilities incurred in complying with obligations, orders,
judgments and decrees attributable to the acts or omissions of Purchaser and its
Affiliates subsequent to the date hereof; or
(d) Operation of Business. Any claims by parties other than Purchaser
for Damages which arise or arose out of Seller's manufacture, marketing, sale or
distribution of the Product, or Seller's ownership of the Purchased Assets, on
or prior to the Closing, excluding all Assumed Liabilities and except as
specifically provided herein.
7.3 Purchaser's Indemnification Covenants. Purchaser shall defend,
indemnify, save and keep harmless Seller and its Affiliates and their respective
successors and permitted assigns against and from all Damages sustained or
incurred by any of them resulting from or arising out of or by virtue of:
(a) Representations. Any material inaccuracy in or material breach of
any representation and warranty made by Purchaser in this Agreement or in any
Purchaser's Ancillary Document; provided, however, that (i) Purchaser shall not
have any liability under this Section 7.3(a) unless and until, and then only to
the extent, the aggregate, cumulative amount of such Damages exceeds the
Indemnity Deductible Amount and (ii) in no event shall the aggregate, cumulative
liability of Purchaser for Damages under this Section 7.3(a) exceeds the
Indemnity Cap Amount; or
(b) Covenants. Any material breach by Purchaser of, or material failure
by Purchaser to comply with, any of its respective covenants or obligations that
are a part of its responsibilities for the Assumed Liabilities from and after
the Closing; or
(c) Operation of Business. Subject to Section 3.2 hereto, any claims by
parties other than Seller for Damages which arise or arose out of Purchaser's
marketing, sale or distribution of the Product, or Purchaser's ownership of the
Purchased Assets, from and after the Closing.
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7.4 Procedure. If any action, claim, suit, proceeding or investigation
arises as to which a right of indemnification provided in this Article VII
applies, party seeking indemnification (the "indemnified party"), shall promptly
notify the party obligated under this Article VII to indemnify the indemnified
party (the "indemnifying party") thereof in writing, and allow the indemnifying
party and its insurers the opportunity to assume direction and control of the
defense against such action, claim, suit, proceeding or investigation, at its
sole expense, including without limitation, the settlement thereof at the sole
option of the indemnifying party or its insurers to the extent that the
indemnified party's liability is not thereby invoked. The indemnified party
shall fully cooperate with the indemnifying party and its insurer in the
disposition of any such matter and the indemnified party will have the right and
option to participate in (but not control) the defense of any action, claim,
suit, proceeding or investigation as to which this Article VII applies, with
separate counsel at its election and cost. If the indemnifying party fails or
declines to assume the defense of any such action, claim, suit, proceeding or
investigation within thirty (30) days after notice thereof, the indemnified
party may assume the defense thereof for the account and at the risk of the
indemnifying party. The indemnifying party shall pay promptly to the indemnified
party any losses, obligations, liabilities, penalties, damages, judgments,
reasonable costs and expenses (including reasonable legal fees) to which the
indemnity under this Article VII applies, as incurred.
7.5 Survival. The provisions of this Article VII shall survive both the
Closing and the expiration or sooner termination of the term of this Agreement.
ARTICLE VIII
Miscellaneous
8.1 Notices. All notices required or permitted to be given hereunder shall
be in writing and may be delivered by hand, by facsimile, by nationally
recognized private courier, or by United States mail. Notices delivered by mail
shall be deemed given three (3) business days after being deposited in the
United States mail, postage prepaid, registered or certified mail. Notices
delivered by hand, by facsimile, or by nationally recognized private carrier
shall be deemed given on the first business day following receipt; provided,
however, that a notice delivered by facsimile shall only be effective if such
notice is also delivered by hand, or deposited in the United States mail,
postage prepaid, registered or certified mail, on or before two (2) business
days after its delivery by facsimile. All notices shall be addressed as follows:
If to Purchaser: If to Seller:
Xxxxxx Laboratories, Inc. Xxxxx-Xxxxxxx Xxxxx Pharmaceuticals Inc.
000 Xxxxxx Xxxxxx 000 Xxxxxx Xxxx
Xxxxxx, Xxxxxxxxxx 00000 Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000
Fax: (000) 000-0000 Fax: (000) 000-0000
Attn: Xx. Xxxxx Xxxx Attn: Senior Vice President and General
Manager, the Americas
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With copies to: With copies to:
X'Xxxxxx & Xxxxxx Phone-Poulenc Xxxxx Pharmaceuticals Inc.
00 Xxxxx XxXxxxx, Xxxxx 0000 000 Xxxxxx Xxxx
Xxxxxxx, XX 00000 Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000
Fax: (000) 000-0000 Attn: General Counsel
Attn: Xxxxxx X. Xxxxxxx Fax: (000) 000-0000
and/or to such other respective addresses and/or addressees as may be designated
by notice given in accordance with the provisions of this Section 8.1.
8.2 Expenses. Each party hereto shall bear all fees and expenses incurred
by such party in connection with, relating to or arising out of the execution,
delivery and performance of this Agreement and the consummation of the
transaction contemplated hereby, including, without limitation, attorneys',
accountants' and other professional fees and expenses.
8.3 Entire Agreement. This Agreement and the other agreements contemplated
hereby or thereby or executed concurrently herewith embody the entire agreement
and understanding between the parties hereto with respect to the subject matter
hereof and supersede all prior agreements, commitments, arrangements,
negotiations or understandings, whether oral or written, between the parties
hereto and their respective Affiliates with respect thereto, including, without
limitation, that certain letter of intent, dated May 20, 1997, between RPR and
Purchaser. There are no agreements, covenants or undertakings with respect to
the subject matter of this Agreement and the other agreements contemplated
hereby or thereby other than those expressly set forth or referred to herein or
therein and no representations or warranties of any kind or nature whatsoever,
express or implied, are made or shall be deemed to be made herein by the parties
hereto except those expressly made in this Agreement and the other agreements
contemplated hereby or thereby.
8.4 Further Actions. Each party agrees to execute, acknowledge and deliver
such further instruments, and to do all such other acts, as may be reasonably
necessary or appropriate in order to carry out the purposes and intent of this
Agreement.
8.5 Non-Waiver. The failure in any one or more instances of a party to
insist upon performance of any of the terms, covenants or conditions of this
Agreement, to exercise any right or privilege in this Agreement conferred, or
the waiver by said party of any breach of any of the terms, covenants or
conditions of this Agreement, shall not be construed as a subsequent waiver of
any such terms, covenants, conditions, right or privileges, but the same shall
continue and remain in full force and effect as if no such forbearance or waiver
had occurred. No waiver shall be effective unless it is in writing and signed by
an authorized representative of the waiving party.
8.6 Applicable Law. This Agreement shall be governed and controlled as to
validity, enforcement, interpretation, construction, effect and in all other
respects by the internal laws of the State of New York applicable to contracts
made in that State.
8.7 Binding Effect; Benefit. This Agreement shall inure to the benefit of
and be binding upon the parties hereto, and their successors and permitted
assigns. Nothing in this Agreement, express or implied, is intended to confer on
any person other than the parties hereto, and their respective successors and
permitted assigns any rights, remedies, obligations or liabilities under or by
reason of this Agreement.
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8.8 Assignability. This Agreement shall not be assignable by either party
without the prior written consent of the other party, which consent shall not be
unreasonably withheld or delayed. No such assignment shall relieve the assignor
of any of its obligations or liabilities under this Agreement.
8.9 Amendments. This Agreement shall not be modified or amended except
pursuant to an instrument in writing executed and delivered on behalf of each of
the parties hereto.
8.10 Headings. The headings contained in this Agreement are for convenience
of reference only and shall not affect the meaning or interpretation of this
Agreement.
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IN WITNESS WHEREOF, the parties have executed this Agreement on the date
first above written.
XXXXXX LABORATORIES, INC. XXXXX-XXXXXXX XXXXX
PHARMACEUTICALS INC.
By: _______________________ By: ________________________
Its:_______________________ Its:________________________
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