EXECUTION COPY EXHIBIT 4.22
SALE AND PURCHASE AGREEMENT
THIS SALE AND PURCHASE AGREEMENT (this "Agreement") is made and entered
into on March 14, 2003 (the "Effective Date") by and between X.XXXXXXXX-XX XXXXX
LTD, a Swiss corporation with office at Xxxxxxxxxxxxxxxxx 000, XX-0000, Xxxxx,
Xxxxxxxxxxx ("Roche-Basel") and XXXXXXXX-XX XXXXX INC., a company organized
under the laws of the state of New Jersey with office at 000 Xxxxxxxxx Xxxxxx,
Xxxxxx, Xxx Xxxxxx 00000-0000 ("Xxxxx-Xxxxxx") (collectively, "Seller"), and
AMARIN CORPORATION plc, an English corporation with offices at 0 Xxxxxx Xxxxxx,
Xxxxxx X0X 0XX Xxxxxx Xxxxxxx ("Buyer").
WHEREAS, Seller has developed and marketed a human pharmaceutical
product under the trademark Tasmar(R) (tolcapone), for treatment of
parkinsonism; and
WHEREAS, Seller has worldwide rights to the above product, including
patent and trademark rights; and
WHEREAS, Buyer wishes to acquire worldwide rights to the product and
Seller wishes to divest itself of worldwide rights to the product.
NOW THEREFORE, in consideration of the terms and conditions set forth
herein, and other good and valuable consideration, the parties hereto agree as
follows:
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT. SUCH PORTIONS HAVE BEEN MARKED AS [*] IN THE TEXT OF
THIS EXHIBIT. THE OMITTED CONFIDENTIAL INFORMATION HAS BEEN FILED SEPARATELY
WITH THE US SECURITIES AND EXCHANGE COMMISSION.
1. DEFINITIONS
1.1 "Active Pharmaceutical Ingredient" or "API" means the
pharmaceutical compound known by the chemical name tolcapone
(3,4-dihydroxy-4'methyl-5-nitrobenzophenone).
1.2 "Affiliate" of a party means any corporation or other business
entity controlled by, controlling, or under common control with, such party. For
this purpose, "control" shall mean direct or indirect beneficial ownership of
more than fifty percent (50%) of the voting securities of or income interest in
such corporation or other business entity. With respect to Seller the term
"Affiliate" shall not include Genentech, Inc., a Delaware corporation, nor
Chugai Pharmaceutical Co., Ltd, a Japanese corporation, unless Seller indicates
in writing that it desires Genentech, Inc. and/or Chugai to be considered an
Affiliate of Seller.
1.3 "Agreement" means this Sale and Purchase Agreement.
1.4 "Assets" has the meaning ascribed to such term in Article 2.
1.5 "Assumed Liabilities" has the meaning ascribed to such term in
Article 3.
1.6 "Bulk Tablet Inventory" means the Active Pharmaceutical Ingredient
in finished dosage tablet pharmaceutical form, including both trade product and
samples, but before labeling and packaging.
1.7 "Buyer" has the meaning ascribed to such term in the preamble to
this Agreement.
1.8 "Buyer Indemnifiable Claims" has the meaning ascribed to such term
in Section 12.1.
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1.9 "Buyer Indemnitees" has the meaning ascribed to such term in
Section 12.1.
1.10 "Buyer Trade Dress" means (i) the printed labels, labeling and
packaging materials, including printed carton, container label and package
inserts, used by Buyer and bearing Buyer's name and, as necessary NDC number or
equivalent for the Product, and (ii) Buyer's tablet imprint and engraving
specification, as sold by Buyer or its Affiliate or sublicensee for Product in
the Territory.
1.11 "Closing" has the meaning ascribed to such term in Article 11.
1.12 "Damages" has the meaning ascribed to such term in Section 12.1.
1.13 "Domain Name" means the domain name Xxxxxx.xxx, which is
registered in the name of the Seller.
1.14 "Effective Date" has the meaning ascribed to such term in the
preamble to this Agreement.
1.15 "FDA" shall mean the United States Food and Drug Administration,
or its foreign equivalent.
1.16 "Finished Dosage Form Inventory" shall mean the Active
Pharmaceutical Ingredient in finished dosage tablet pharmaceutical form and
using Seller Trade Dress, ready for shipping for distribution or sale to an
ultimate user, distributor, or dispenser, including both trade product and
samples.
1.17 "Indemnified Party" has the meaning ascribed to such term in
Section 12.3.
1.18 "Indemnifying Party" has the meaning ascribed to such term in
Section 12.3.
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1.19 "Law" means any federal, state, local or other law, ordinance,
rule, regulation, or governmental requirement or restriction of any kind, and
any rules, regulations, and orders promulgated thereunder.
1.20 "Major Countries" means the United States of America, Canada,
United Kingdom, France, Germany, Italy, and Spain.
1.21 "Manufacturing Technology" means the documents to be set forth
prior to Closing on Schedule 1.21, which includes specifications and test
methods for Product set forth in the Registrations and sold by the Seller or its
Affiliates under the name Tasmar(R) (tolcapone) in the Territory, Active
Pharmaceutical Ingredient, packaging, stability and other applicable
specifications, manufacturing and packaging instructions, master formula,
validation reports (process, analytical methods and cleaning), stability data,
analytical methods, records of complaints, annual product reviews to the extent
available, and all other master documents (including the Drug Master File)
necessary for the manufacture, control, and release of the Product as conducted
by, or on behalf of, Seller, under the Roche Process, or otherwise.
1.22 "NDA" means a New Drug Application, Supplemental New Drug
Application or Marketing Authorization Application for the Product filed with
the United States Food and Drug Administration pursuant to 21 CFR, Part 314, or
its foreign equivalent, and all supplements, amendments, and revisions thereto.
1.23 "Net Sales" means the amount of gross sales of Product in the
Territory invoiced by Buyer, its Affiliates and sublicensees during the period
commencing on the Closing and ending December 31, 2012, less deductions of
returns (including allowances actually given for spoiled, damaged, out-dated,
rejected, returned Product sold, bad debt, withdrawals and recalls), rebates
(price reductions, rebates to social and welfare systems, chargebacks,
government mandated rebates and similar types of rebates), volume
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(quantity) discounts, and taxes (value added or sales taxes, government mandated
exceptional taxes and other taxes directly linked to the gross sales amount).
1.24 "Patents" means all patents, patent applications and statutory
invention registrations, including reissues, divisions, continuations,
continuations-in-part, supplementary protection certificates, extensions and
reexaminations thereof, all inventions disclosed therein, all rights provided by
international treaties and conventions, and all rights to obtain and file for
patents and registrations thereto in the Territory, now owned by Seller as of
the Effective Date that relate to Product, the current schedule of which are
listed on Schedule 1.24 attached hereto.
1.25 "Product" means finished pharmaceutical product containing Active
Pharmaceutical Ingredient.
1.26 "Product Intellectual Property" means (i) Patents, (ii) Product
Trademarks; (iii) Manufacturing Technology, (iv) the Domain Name, and (vi)
copyrights in and to the Product Marketing Materials.
1.27 "Product Marketing Materials" means all marketing materials used
by Seller or its Affiliate with respect to the Product in the Territory that are
in existence as of the Effective Date, including advertising materials, training
materials, product data, price lists, mailing lists, sales materials, market
information, promotional materials, and artwork for the production of packaging
components.
1.28 "Product Registrations" or "Registrations" means all regulatory
filings, including NDAs, directly related to Product, including those listed on
Schedule 1.28 attached hereto, and related (i) supporting documents, including
non-clinical and clinical study results, and (ii) records maintained under cGMP,
or other record keeping or reporting requirements of the FDA, the Environmental
Protection Agency, the Occupational Health and Safety Administration or any
other governmental or regulatory authorities, including
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warning letters, notices of adverse finding letter, audit reports and responses,
adverse event files, safety databases, safety reports and complaint files.
1.29 "Product Trademarks" means the trademarks, including registrations
and applications for registrations thereof (and all renewals, modifications and
extensions thereof), together with the goodwill associated therewith, listed on
Schedule 1.29 attached hereto.
1.30 "Retained Liabilities" has the meaning ascribed to such term in
Article 3.
1.31 "Roche Process" means the manufacturing process approved in the
NDA for the Product set forth in the Registrations and sold by Roche or its
Affiliate under the name Tasmar(R) (tolcapone) in the Territory.
1.32 "Seller" has the meaning ascribed to such term in the preamble to
this Agreement.
1.33 "Seller Indemnifiable Claims" has the meaning ascribed to such
term in Section 12.2.
1.34 "Seller Indemnitees" has the meaning ascribed to such term in
Section 12.2.
1.35 "Seller Trade Dress" means (i) the printed labels, labeling and
packaging materials, including printed carton, container label and package
inserts, used by Seller and bearing Seller's name and, as necessary NDC number
or equivalent for the Product, and (ii) Seller's tablet imprint and engraving
specification, as set forth in the Registrations and sold by Seller or its
Affiliate under the name Tasmar(R) (tolcapone) in the Territory.
1.36 "SWITCH Trial" means the clinical trial presently being conducted
in Europe comparing efficacy of Tasmar and entacapone, designated as Trial No.
NR 16188.
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1.37 "Territory" means all countries of the world, except Japan, unless
the rights in Japan are subsequently transferred to Buyer as provided herein, at
which time Territory shall be deemed to include Japan.
2. ASSETS BEING SOLD
2.1 Asset Sale. Subject to the terms and conditions of this Agreement,
Seller shall assign and shall deliver to Buyer at Closing all of the right,
title, and interest of Seller in and to the Product, consisting of (i) all
Product Intellectual Property, including Seller's files pertaining thereto; (ii)
all Product Registrations, including Seller's files pertaining thereto; (iii)
all Product Marketing Materials; and (iv) all of Seller's current inventory of
Finished Dosage Form Inventory (together, the "Assets").
Except as expressly stated herein, Seller does not, under this
Agreement, convey and Buyer does not purchase the right, title, or interest of
Seller in and to any assets not listed in this Article 2. Buyer does not, under
this Agreement, purchase any right, title or interest in or to the name(s) of
Seller or in the Roche Hexagon Design.
Except as expressly stated herein, Seller shall retain no right to
distribute, market or sell the Product or the Assets in the Territory.
2.2 Japan Seller represents and Buyer acknowledges that Seller has an
obligation to offer the right to sell Product in Japan to Chugai. Seller shall
notify Buyer in writing within one (1) year of Closing of the intention of
Chugai to sell Product in Japan. If Seller notifies Buyer that Chugai has no
intention to sell Product in Japan, then Buyer shall have the right, upon
written notice to Seller, to have Japan included in the Territory for this
Agreement for no additional consideration other than cost of supply of Product
as consistent with Article 5. If Chugai intends to sell Product in Japan, then
(i) Seller shall
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have the right to use the Product Intellectual Property solely to manufacture or
have manufactured, to develop or have developed and to have marketed by Chugai,
Product for sale in Japan and (ii) Seller shall use reasonable diligent efforts
to conclude an agreement with Chugai regarding Product that requires Chugai to
cooperate with Buyer as to adverse event reporting, safety database sharing and
global supply of Product.
2.3 License Seller hereby grants to Buyer a non-exclusive,
royalty-free, perpetual, irrevocable right and license, under any patent right
acquired by Seller or its Affiliate after the Effective Date, to make, have
made, use, offer for sale, sell and import Product in the Territory.
3. LIABILITIES
3.1 Liabilities.
Subject to Section 12.1, Buyer shall assume, be responsible for and
pay, perform and discharge when due all liabilities related to the Product, and
the use of the Assets, that pertain to Product used, sold or distributed by or
on behalf of Buyer on or after the Closing, except to the extent such liability
is a third party cost incurred in the conduct of the SWITCH Trial (collectively
"Assumed Liabilities").
Seller shall retain, be responsible for and pay, perform and discharge
when due all liabilities related to the Product, and the use of the Assets, that
pertain to Product used, sold or distributed by or on behalf of Seller before
the Closing, except to the extent such liability is caused by any statement or
representation attributable to Buyer, its Affiliate or its directors, officers,
employees and agents that is inconsistent with or contrary to the Product
Marketing Materials or Seller Labeling (collectively "Retained Liabilities").
4. CONSIDERATION
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4.1 Up-Front Buyer shall pay to Seller the non-refundable,
non-creditable sum of TWELVE MILLION FIVE HUNDRED THOUSAND (US $12,500,000.00)
US DOLLARS, which Buyer shall pay to Seller on the date of Closing by wire
transfer as instructed by Seller.
Buyer shall pay amounts due to Seller under this Section 4.1, by wire
transfer, allocated to Roche-Basel and Xxxxx-Xxxxxx, as requested by Seller in
writing.
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4.2 Milestones (a) Buyer shall pay to Seller the non-refundable,
non-creditable sum of [*]MILLION (US $[*],000,000) US DOLLARS, which Buyer shall
pay to Seller by wire transfer as instructed by Seller within fifteen (15) days
after the date of the first shipment of Product, after [*]in the European Union,
as constituted from time to time ("EU"), by or on behalf of Buyer to a
wholesaler or distributor for sale in the United Kingdom, France, Germany, Italy
or Spain.
(b) Buyer shall pay to Seller the non-refundable, one-time,
non-creditable sum of [*]MILLION (US $[*],000,000) US DOLLARS, which Buyer shall
pay to Seller by wire transfer as instructed by Seller within fifteen (15) days
after the date aggregate Net Sales of Product in a calendar year in the United
States of America verifiably reaches [*]million US dollars (US$[*],000,000).
(c) Buyer shall pay to Seller the non-refundable, one-time,
non-creditable sum of [*]MILLION (US $[*],000,000) US DOLLARS, which Buyer shall
pay to Seller by wire transfer as instructed by Seller within fifteen (15) days
after the date aggregate Net Sales of Product in a calendar year in EU
verifiably reaches [*]million US dollars (US$[*],000,000).
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(d) Buyer shall pay to Seller the non-refundable, one-time,
non-creditable sum of [*]MILLION (US $[*],000,000) US DOLLARS, which Buyer shall
pay to Seller by wire transfer as instructed by Seller within fifteen (15) days
after the date aggregate Net Sales of Product in a calendar year in EU
verifiably reaches [*] million US dollars (US$[*]000,000).
(e) Buyer shall pay to Seller the non-refundable, one-time,
non-creditable sum of [*]MILLION (US$[*],000,000) US DOLLARS, which Buyer shall
pay to Seller by wire transfer as instructed by Seller within fifteen (15) days
after the date aggregate Net Sales of Product in a calendar year in the
Territory verifiably reaches [*]million US dollars (US$[*],000,000).
(f) Buyer shall pay to Seller the non-refundable, one-time,
non-creditable sum of [*]MILLION ($[*],000,000) US DOLLARS, which Buyer shall
pay to Seller by wire transfer as instructed by Seller within fifteen (15) days
after the date aggregate Net Sales of Product in a calendar year in the
Territory verifiably reaches [*]million US dollars (US $[*],000,000).
Buyer shall pay amounts due to Seller under this Section 4.2, by wire
transfer, allocated to Roche-Basel and Xxxxx-Xxxxxx, as requested by Seller in
writing.
4.3 Sales Commission. Buyer shall pay to Seller an amount equal to
[*]percent ([*]%) of Net Sales of Product in each country in the Territory
during the period commencing on the Closing and ending on December 31, 2012.
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(a) Accounting Period and Net Sales Accounting. Each Accounting Period
commences quarterly respectively on January 1, April 1, July 1 and October 1,
each being the first day of an Accounting Period, and finishing respectively on
March 31, June 30, September 30, and December 31, each being the last day of an
Accounting Period. Buyer shall pay amounts due under this Section 4.3 in US
Dollars. Buyer shall calculate such payments quarterly as of March 31, June 30,
September 30 and December 31 and shall make payment within the forty-five (45)
days after the end of each Accounting Period in which such Net Sales occur.
Whenever calculating sales commission requires conversion from any foreign
currency, Buyer shall make such conversion as follows: Buyer shall use the
conversion rate for each applicable currency as quoted in the Financial Times
(or, if not published, the Wall Street Journal, European Edition) for the last
day of each Accounting Period.
(b) Sales Commission Reports. Buyer shall accompany each payment by a
report summarizing for Product the gross sales and Net Sales achieved during the
relevant three-month period, the currency conversion rates used, and the total
payments due.
(c) Withholding Taxes. If provision is made in law or regulation of any
country for withholding of taxes of any type, levies or other charges with
respect to any amount payable under this Agreement, Buyer shall promptly pay
such tax, levy or charge for and on behalf of Seller to the proper governmental
authority. Buyer may deduct any such tax, levy or charge actually paid from
amount due. Buyer agrees to assist Seller in claiming exemption from such
deductions or withholdings under double taxation or similar agreement or treaty
from time to time in force and in minimizing the amount required to be so
withheld or deducted. Buyer shall provide documentation from time to time as is
needed for Seller to confirm the payment of tax.
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(d) Audit. Buyer and its Affiliates and sub-licensees shall keep, full,
true and accurate books of account containing all particulars that may be
necessary for the purpose of verifying Net Sales and calculating all amounts
payable to the Seller. Such books of accounts shall be kept at their principal
place of business. Seller has the right, from time to time but not more than
once per calendar year, to engage, at its own expense, an independent public
accountant reasonably acceptable to Buyer to perform, on Seller's behalf, an
audit, conducted in accordance with United Kingdom generally accepted accounting
practices (UK GAAP), of such books and records of Buyer and its Affiliates and
sub-licensees that are reasonably necessary to confirm the correctness of any
report or payments made under this Agreement. Upon timely request and at least
thirty (30) days' prior written notice from the Seller, such audit shall be
conducted during regular business hours in such a manner as to not unnecessarily
interfere with the Buyer's normal business activities. All information, data,
documents and abstracts herein referred to shall be used only for the purpose of
verifying sales commission reports or compliance with this Agreement. Audit
results shall be shared by and be binding upon the parties. If the audit reveals
an underpayment, the Buyer shall promptly make up such underpayment. If the
audit reveals that the royalties owed by Buyer for the countries specifically
requested in total have been understated by more than five percent (5%), then
Seller shall pay the costs of such audit.
4.4 Late Payment Any payment under this Agreement that is not timely
paid shall bear interest, to the extent permitted by applicable law, at the
average one-month European Interbank Offered Rate (EURIBOR) as reported by
Bloomberg (or a successor or similar organization) from time to time, such rate
to be determined as of the due date and calculated for the number of days such a
payment is overdue.
5. SUPPLY
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5.1 Supply of Finished Dosage Form Inventory The Finished Dosage Form
Inventory in the possession or control of Seller on Closing shall be delivered
to Buyer, as provided in Section 11.4. Schedule 5.1 lists, on a
country-by-country basis, as of January 31, 2003, Finished Dosage Form Inventory
Seller had in its possession or control.
Sales of all such Product shall be subject to the payment of sales
commission as provided in Section 4.3.
As promptly as practicable, but in no event later than ninety (90) days
after Closing, Seller and Buyer shall discuss and agree upon the amount of the
payment under Section 4.1 that is allocable to the Finished Dosage Form
Inventory in the possession or control of Seller on Closing.
5.2 Buyer Trade Dress Promptly following Closing, Buyer shall notify
Seller in writing of the initial Buyer Trade Dress for which Buyer proposes to
seek FDA approval. With the exception of tablet imprint and NDC numbers, the
proposed initial Buyer Trade Dress shall be substantially the same as the Seller
Trade Dress. Within ten (10) days after receipt of the proposed initial Buyer
Trade Dress, Seller shall notify Buyer if Seller believes such proposed initial
Buyer Trade Dress will require Seller to make additional plant, property or
equipment investment to implement such initial Buyer Trade Dress, with an
itemization of such projected costs. If Seller provides such notice, then the
parties shall discuss each item in good faith and attempt to identify the lowest
reasonable cost option for the proposed change acceptable to each party in its
discretion. For each item identified by Seller, at Buyer's option, Buyer shall
amend its proposed Buyer Trade Dress so that no such investment is required or
shall bear full responsibility to Seller for the expenses
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identified in the notice to implement such initial Buyer Trade Dress. If Seller
does not timely provide such notice, then Seller shall be deemed to have agreed
to implement the proposed initial Buyer Trade Dress.
Following agreement between Seller and Buyer with respect to the
initial Buyer Trade Dress, Buyer, at its own expense shall notify FDA of the
transfer and obtain such FDA approvals necessary for the agreed initial Buyer
Trade Dress for Product, including obtaining new NDC numbers for Product in all
relevant jurisdictions. Buyer shall provide Seller, free of charge, with camera
ready artwork and hard copy samples of the initial Buyer Trade Dress as approved
by FDA. Prior to December 31, 2004, Buyer shall not change Buyer Trade Dress
without prior written consent of Seller, not to be unreasonably withheld. It
shall not be unreasonable for Seller to withhold consent if any such change
requires any investment by Buyer for plant, property or equipment to implement
such change that Buyer will not agree to reimburse. If in any country of the
Territory any FDA requires change of the Buyer Trade Dress, other than for
changes resulting from a change in the manufacturing process (as to which Seller
shall bear its own costs), then Buyer shall bear all Seller costs to implement
such change with respect to supply of Product.
5.3 Supply of Product. Prior to December 31, 200[*], Buyer shall have
entered into an agreement with a third party to procure a source of Active
Pharmaceutical Ingredient, semi-finished dosage form and finished dosage form
for the Territory. However, the parties anticipate that prior to December 31,
200[*] Finished Dosage Form Inventory will exhaust. As a result, the parties
agree as follows:
(a) Buyer's Forecast. Buyer will provide Seller with a rolling
non-binding twelve
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(12) month forecast, on a quarter-by-quarter basis, through December 31, 200[*],
of Buyer's projected purchases for each country of the Territory of (i) each of
the following pack sizes, by trade/sample, for the 100 mg tablet dosage of
Product: 30 tablets/pack (blister or bottle), 60 tablets/pack (blister or
bottle), 90 tablets/pack (bottle), 100 tablets/pack (bottle) and (ii) each of
the following pack sizes, by trade/sample, for the 200 mg tablet dosage of
Product: 30 tablets/pack (blister or bottle), 90 tablets/pack (bottle), 100
tablets/pack (bottle). Each rolling forecast will be provided no later than
forty five (45) days following the end of each calendar quarter. For each pack
size of Product, the minimum order quantity ("MOQ") shall be one thousand three
hundred and fifty (1350) packages, except for the 90 tablets/pack, for which the
MOQ shall be 24,000 bottles of 100 mg tablets and 12,000 bottles of 200 mg
tablets. The first quarter of each such rolling forecast shall constitute a firm
order. Buyer shall provide the first forecast within thirty (30) days after
Closing.
Buyer will issue purchase orders against such forecast, and Seller
commits to supply not less than 80% nor more than 120% of each pack size for
each strength against the firm order contained in the forecast. Seller shall
supply the requirements ordered, in each case with a delivery date of not less
than six (6) months or more than nine (9) months from the date of such purchase
order.
It is understood that Seller will fill Buyer's initial orders for
Product using Bulk Tablet Inventory presently on hand, which Seller shall
convert to Finished Dosage Form using Seller Trade Dress.
(b) MOQ Per Order. The MOQs stated above shall be designated in each
purchase order from Buyer and calculated by strength (100 mg, 200mg), package
size (30, 90, 100), presentation (bottles, blister cards), and the grouped
countries shown on Schedule 5.1(b), attached. For example, an order of 100mg
product for New Zealand and Australia could be aggregated to meet the MOQ (same
strength, pack size and
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country group). An order for 100mg Product for Switzerland and Brazil could also
be aggregated to reach the MOQ (same strength, pack size and country group) but
for Brazil and Singapore, could not be aggregated for that purpose (same group,
but different pack size).
(c) Payment for Supply. In addition to the future payment by Buyer of
sales commissions under Article 4, Buyer shall pay Seller in accordance with
Schedule 5.3, within thirty (30) days of the later of delivery or invoice.
(d) Seller and Buyer agree that except as provided in Section 5.6,
Seller shall have no obligation to produce after the Effective Date any Active
Pharmaceutical Ingredient, or to supply any order for Product received by Seller
after December 31, 200[*].
(e) At Buyer's option, Seller shall (i) at Buyer's cost of US$[*]/kg of
API, ship to Buyer any Active Pharmaceutical Ingredient, including in the form
of Bulk Tablet Inventory, in its possession and control as of December 31,
200[*], which is not otherwise designated to be produced into finished dosage
form as provided hereunder or (ii) at Seller's cost, destroy any Active
Pharmaceutical Ingredient and any Bulk Tablet Inventory in its possession and
control as of December 31, 200[*], which is not otherwise designated to be
produced into finished dosage form as provided hereunder.
5.4 Shipment. All shipments under this Article 5, will be F.C.A.
(Incoterms 2000) origin. Shipping or freight, and any tariffs or duties, will be
paid by Buyer. Title and risk of loss will pass to Buyer upon delivery to
Buyer's designated common carrier at Seller's designated distribution center
appropriate for the destination of that shipment.
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5.5 Quality Testing Seller, at its expense, shall perform quality
assurance and quality control testing with respect to Product supplied under
this Article 5, including Seller's stability testing as then applicable to the
Product, so as to verify the conformity with Seller specifications in accordance
with Seller's standard practice and applicable Law and Product Registrations,
and shall provide the results thereof to Buyer in the form of a Certificate of
Analysis ("COA"). The Seller specifications are as set forth in the Product
Registration NDA No. 20-697.
5.6 Failure Within a sixty (60) day period from receipt by Buyer of
shipment by Seller of Product under this Article 5, Buyer may notify ("Notice of
Defect") Seller in writing of all of Buyer's claims on account of failure to
meet cGMP or other applicable Law, NDA or Product Registration requirements,
specifications or quality standards of Article 5.5 ("Defective"). Buyer and
Seller shall cooperate in good faith to determine all Product which is
Defective. For Defective Product for which Seller receives timely Notice of
Defect, Buyer shall be authorized to return such Product to Seller at Seller's
expense and Seller shall replace such returned Product at no charge to Buyer
within one hundred twenty (120) days of Seller's receipt of the Notice of
Defect.
5.7 Recalls If either Buyer or Seller believes a recall of the Product
provided to Seller under Article 5 is required or desirable, then both parties
shall cooperate fully regarding the investigation and disposition of such
matter. If any recall of the Product is agreed by the parties or required by any
governmental authority, the cost and the conduct of such recall shall be borne
by the party(s) which has caused the conditions causing such recall. The other
party shall be entitled to such credits, replacements, reimbursements and
allowances from the causing party as shall be necessary in order to assure that
all cost
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reasonably incurred by the other party to effect such recall are paid or
reimbursed by the causing party. For any recall not caused by or attributable to
Seller's failure to provide Product which conforms to the requirements of this
Agreement, Seller's aggregate cost for which it is responsible under this
Section 5.7 shall not exceed the additional cost that Buyer paid Seller under
Article 5.3 for the Product affected by the recall.
6. REPRESENTATIONS AND WARRANTIES OF SELLER
As of the Effective Date, Seller hereby represents and warrants to the
Buyer as follows:
6.1 Organization; Authorization; Enforceability Each individual entity
constituting Seller is a corporation duly incorporated, validly existing and in
good standing under the law of the jurisdiction of its incorporation, with full
corporate power and authority to consummate the transactions contemplated
hereby. Seller has the full corporate power and authority to consummate the
transactions contemplated hereby. The execution, delivery and performance of
this Agreement by Seller have been duly authorized by all requisite corporate
action. This Agreement constitutes the legal, valid and binding obligation of
Seller, enforceable against it in accordance with its terms, subject, as to
enforcement, to bankruptcy, insolvency, reorganization and other laws of general
applicability relating to or affecting creditors' rights and to the availability
of particular remedies under general equity principles.
6.2 Title to Assets Seller has, and will convey good and marketable
title to the Assets at Closing, free and clear of any and all liens,
encumbrances, charges, claims, restrictions, pledges, security interests, or
impositions of any kind (including those of secured parties). Seller has not
granted to a third party any license, interest or other right
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in or to the Assets. None of the Assets are leased, rented, licensed or
otherwise not owned by Seller.
6.3 Taxes Seller has duly and timely filed all Federal, State and local
excise, sales, use, withholding and other returns required to be filed by Seller
related to or in connection with the Product and the Assets and has duly paid or
established adequate reserves for the proper payment of all taxes and
governmental charges relating to or in connection with the Product and the
Assets. There are no outstanding tax liens filed against the Sellers that affect
the Product or the Assets.
6.4 Patents To the best of Seller's knowledge, (i) the Product
Intellectual Property consists of all intellectual property owned or controlled
by Seller necessary for Buyer to make, have made, use, sell and distribute the
Product in the Territory; and (ii) no threat or claim of infringement or
possible infringement of any third party's intellectual property rights is now
pending or has been asserted against Seller in connection with its manufacture,
use and sale of the Product in the Territory. Claim 14 of US Patent No.
5,236,952 in Schedule 1.24 claims the Active Pharmaceutical Ingredient per se in
the United States of America.
6.5 Safety All serious adverse events (as defined under US regulatory
Law pertaining to pharmaceutical products) relating to the Product which are
known to Seller have been recorded in its safety database and have been provided
to Buyer prior to the Effective Date.
6.6 LIMITATION OF WARRANTY AND DISCLAIMERS UNLESS OTHERWISE AGREED IN
WRITING AND IN THIS SECTION 6.6 AND EXCEPT FOR THE WARRANTIES SET OUT IN THIS
AGREEMENT, SELLER MAKES NO WARRANTY OR REPRESENTATION WHATSOEVER, WHETHER,
EXPRESS OR IMPLIED, IN RESPECT OF THE ASSETS TRANSFERRED TO BUYER HEREUNDER.
SELLER'S LIABILITY FOR BREACH OF A REPRESENTATION AND/OR WARRANTY SHALL BE
LIMITED TO THE
20
WARRANTIES AND/OR REPRESENTATIONS SET OUT IN THIS AGREEMENT. SELLER WILL NOT AND
DOES NOT WARRANT THAT OWNERS OF PRODUCTS THAT ARE SUBSTANTIALLY SIMILAR TO OR
IDENTICAL WITH THE PRODUCT WILL NOT ATTEMPT TO REGISTER AND SELL SUCH PRODUCT IN
THE TERRITORY. SELLER MAKES NO REPRESENTATION OR WARRANTY AS TO (A) THE
PROSPECTS, FINANCIAL, OR OTHERWISE, OF MARKETING THE PRODUCT IN THE TERRITORY;
OR (B) EXCEPT AS STATED HEREIN, ANY PATENT RIGHTS OR TRADEMARK RIGHTS OR THE
TRADE DRESS FOR THE PRODUCT. EXCEPT AS OTHERWISE SET FORTH IN THIS AGREEMENT
SELLER MAKES NO WARRANTY OF MERCHANTABILITY OF ANY OF THE ASSETS OR OF THE
FITNESS OF ANY OF THE ASSETS FOR ANY PURPOSE.
6.7 Consents and Approvals The execution, delivery and performance of
this Agreement by Seller does not require the consent, approval or authorization
of, or notice, declaration, filing or registration with, any government or
regulatory authority and the execution, delivery or performance of this
Agreement does not violate any law, rule or regulation applicable to Seller.
6.8 Regulatory Filings Seller has filed all regulatory submissions and
has paid all fees required to maintain the current and active status of the
Registrations. The Registrations are complete and up to date; provided, however,
that while Seller has made reasonable efforts to satisfy itself and believes the
list of Registrations is complete and up to date, Seller gives no warranty that
the list of Registrations is complete, except as to the US and the other Major
Countries, as to which Seller provides an unqualified warranty of accuracy and
completeness of the Registration information provided in Schedule 1.28. As of
the Closing, there are no amounts due to any regulatory authority or otherwise
with respect to the Registrations.
6.9 Litigation Except as disclosed in Schedule 6.9 there are no
actions, suits or proceedings pending, or to Seller's knowledge threatened
against the Seller, before any
21
court or governmental or administrative body or agency affecting the Product or
the Assets (including without limitation the Intellectual Property). Seller is
not presently subject to any injunction, order or other decree of any court of
competent jurisdiction which affects the Product or the Assets.
6.10 No Competing Product. As of Closing, Seller does not have any
clinical development project in any country of the Territory directed to
development of a COMT inhibitor for human pharmaceutical use and in the United
States of America Seller does not promote any anti-parkinsonian drug to
physicians. In addition, to the knowledge of Seller's licensing department based
on a search of publicly available databases, other than entacapone and a product
of Bial-Aristegui, there are no third party COMT inhibitors that are marketed or
in Phase II or later clinical development in the Major Countries.
6.11 Survival The ability of Buyer to act upon representations and
warranties of Seller shall survive until the earlier of (i) December 31, 2004
and (ii) the period ending eighteen (18) months following Closing.
7. REPRESENTATIONS AND WARRANTIES OF BUYER
As of the Effective Date, Buyer hereby represents and warrants to
Seller as follows:
7.1 Organization, Authorization, Enforceability Buyer is a company duly
incorporated, validly existing and in good standing under the law of the
jurisdiction of its incorporation, with full corporate power and authority to
consummate the transactions contemplated hereby. The execution, delivery and
performance of this Agreement by Buyer have been or, prior to Closing, will be
duly authorized by all requisite corporate action. This Agreement constitutes
the legal, valid and binding obligation of Buyer, enforceable against it in
accordance with its terms, subject, as to enforcement, to bankruptcy,
insolvency, reorganization and other laws of general applicability relating to
or
22
affecting creditors' rights and to the availability of particular remedies under
general equity principles.
7.2 Due Diligence Buyer represents that Buyer has conducted a due
diligence investigation into the Assets and into the Product. Buyer is aware
that (i) Market Authorization for the Product has been withdrawn from the EU,
(ii) Seller has withdrawn the Product in Canada, and (iii) Seller does not
actively promote Product in the United States of America. In addition, in the
course of the due diligence investigation Seller has made available to Buyer a
list of Seller's sales prices for Product.
7.3 Litigation There are no actions, suits or proceedings pending, or
to Buyer's knowledge threatened against the Buyer, before any court or
governmental or administrative body or agency affecting the ability of Buyer to
consummate this Agreement.
7.4 Consents and Approvals Other than approval or clearance under the
Xxxx-Xxxxx-Xxxxxx Act in the US ("HSR ACT") and any similar Law in other
jurisdictions, the execution, delivery and performance of this Agreement by
Buyer does not require the consent, approval or authorization of, or notice,
declaration, filing or registration with, any government or regulatory authority
and the execution, delivery or performance of this Agreement does not violate
any law, rule or regulation currently applicable to Buyer.
7.5 Financing Commitment Buyer will have at Closing obtained financing
approved by its board of directors which is sufficient to make the upfront
payment called for by Section 4.1 of this Agreement.
7.6 Survival The ability of Seller to act upon the representations and
warranties of Buyer shall survive until the earlier of (i) December 31, 2004 and
(ii) the period ending eighteen (18) months following Closing.
8. SELLER'S COVENANTS
23
8.1 Use of Assets Seller agrees that from the Effective Date until the
Closing that Seller shall:
8.1.1 maintain the Assets in good status and condition and not enter
into any material contract or commitment, engage in any transaction,
extend credit or incur any obligation with respect to the Assets,
outside of the ordinary course of business;
8.1.2 not materially change Seller's current manufacture, market or
sales activities for the Product prior to the Closing;
8.1.3 maintain insurance covering the Assets in such amounts and of
such kinds as are comparable to that in effect on the date of this
Agreement, if any; and
8.1.4 shall not incur any indebtedness or liability that will or likely
would create a lien or other encumbrance against any of the Assets.
8.2 Customer Lists and Government Contracts Within ninety (90) days
after the Effective Date, Seller shall provide to Buyer a copy of the existing
(as of the Effective Date) lists of current customers for Product, including
government contracts.
Seller is under no obligation to secure any consent under any agreement
or arrangement for the sale of the Product to Seller's customers other than as
expressly stated in this Agreement. Seller shall not be required to make any
payment of any kind whatsoever to Buyer or any third party regarding any
agreement or arrangement for the sale of the Product to Seller's customers.
Seller shall be under no obligation to contact any of its present customers.
Buyer shall be solely responsible for procuring any agreements or other
arrangement for the sale of the Product in the Territory to any customer
including
24
but not limited to any federal, state or other governmental agency or
body, but Seller shall cooperate as reasonably requested by Buyer in making any
transition of government agreements for the purchase of Product from Seller to
Buyer.
8.3 Announcement Promptly following Closing, Seller shall send a
letter, in form and substance mutually acceptable to Buyer and Seller, to
Seller's customers, announcing the transfer of the Product to Buyer and
referring all future inquiries regarding the Product to Buyer. Buyer may provide
to Seller an additional list of names and addresses for distribution of such
letter, but all costs for such additional distribution shall be borne by Buyer.
8.4 SWITCH Trial At Seller's cost, Seller shall use reasonably diligent
efforts to pursue [*] in the EU and will coordinate with Buyer on progress.
Notwithstanding the above, there shall be no obligation on the part of Seller to
conduct any clinical activity other than the SWITCH Trial.
9. BUYER'S COVENANTS
9.1 Marketing Efforts Buyer will use reasonable diligent efforts,
either itself or with a partner, to market and sell the Product in the Major
Countries of the Territory. It is understood that Buyer may enter into one or
more sublicense or distribution arrangements with third parties for the Major
Countries, with the consent of Seller, not to be unreasonably withheld. If Buyer
grants rights to a partner to market or sell Product in any country of the
Territory, or enters into one or more sublicense or distribution arrangements
with a third party for any country of the Territory, then Buyer shall use
reasonable efforts to ensure that all of the applicable terms and conditions of
this Agreement apply to the third party to the same extent they apply to Buyer
for all purposes. In any event, Buyer retains full responsibility hereunder for
the performance of all obligations so imposed on such third party and will
itself account to Seller for all sales commissions under Article 4 due under
25
this Agreement by reason of such grant or arrangement. Buyer may not divest its
rights in the Product in the Major Countries prior to December 31, 2012.
9.3 Distribution If, in a country of the Territory, Buyer wishes to use
a third party to distribute Product, Buyer shall provide Seller with written
notice of such intention. Buyer and Seller each have the right, without
obligation, to negotiate with each other an arrangement under which Seller will
distribute Product in such country, under terms to be negotiated in good faith.
9.4 Taxes Buyer covenants and agrees to pay on a timely basis all
federal, state and local sales, transfer and use taxes and customs duties with
respect to the sale and purchase of the Assets, and Buyer covenants to reimburse
Seller for any such taxes and duties for which Seller is liable for payment
within thirty (30) calendar days of receiving notice from Seller of such
payment.
9.5 HSR Act. Buyer covenants to effect filing of any required
application for approval pursuant to the HSR Act no later than ten (10) days
from the Effective Date.
10. COVENANTS BY BUYER AND SELLER
10.1 Technology Transfer In the interest of avoiding the possibility of
a dispute, prior to Closing the parties will have prepared and agreed upon a
list of Manufacturing Technology that is to be attached as Exhibit 1.21. The
list will describe all of the Manufacturing Technology that has been or shall be
provided by Seller to Buyer. In addition, during a period commencing on the
Closing and ending December 31, 2004, Seller shall provide up to fifty six
(56) man hours of assistance, as reasonably requested by Buyer, to enable Buyer
to implement the Manufacturing Technology. Buyer agrees to reimburse Seller for
the reasonable out-of-pocket travel and lodging expenses of Seller's personnel
who provide assistance to Buyer at Buyer's facilities. Other than as provided in
26
this Section 10.1, Buyer has no further obligation to Seller with respect to
providing Manufacturing Technology or services for implementing the
Manufacturing Technology.
10.2 Transfer of Registrations At or following Closing, Buyer and
Seller shall execute such documents as Buyer may reasonably request in order to
transfer the Registrations. Buyer shall pay any user fees associated with the
Product that accrue after Closing, including user fees that accrue prior to
transfer of such Registrations. Seller shall notify the FDA promptly following
the Closing of the transfer of the Assets. Buyer shall update the NDAs and drug
listings, and obtain approvals to such transfer, if required by FDA.
10.3 Medical Questions For up to two (2) months after Closing both
parties shall coordinate responses to questions and complaints regarding the
Product, with Buyer assuming complete responsibility at the earliest possible
date. After such two (2) month period (or earlier assumption of responsibility
by Buyer), Buyer shall be solely responsible for responding to all medical
questions or complaints and Seller shall immediately refer any such medical
questions or complaints, including notices of adverse event findings, adverse
event files and safety reports, to Buyer for handling.
10.4 Press Releases Neither the Seller nor the Buyer, nor any Affiliate
thereof, will issue or cause publication of any press release or other
announcement or public communication with respect to this Agreement or the
transactions contemplated hereby without the prior written consent of the other
party, which consent will not be unreasonably withheld or delayed.
10.5 Rebates Seller or its Affiliates shall be responsible for any
rebate payments with respect to the Product, whether by agreements, a government
mandate or otherwise, for all Products sold or distributed prior to the Closing,
and Buyer shall be responsible for any rebate payments with respect to the
Products, whether by agreements, government mandate or otherwise, for all
Products sold or distributed on or after the
27
Closing. If either party or its Affiliate makes payment of rebates in its own
name due to governmental requirements pertaining to Products for which the other
party is responsible, that other party will reimburse the paying party or its
Affiliate such amount within thirty (30) days following the date the paying
party or its Affiliate notifies the other that it or its Affiliate has made such
payments. For the purposes of this Section, "sold or distributed" means the
issuance of an invoice for Product shipped.
10.7 Contract Chargebacks As of the Closing, Seller or its Affiliates
shall notify all parties with purchase contracts covering the Product that said
contract will terminate as to the Product in accordance with its terms. Seller
shall be responsible for all costs and expenses with respect to claims under
contract chargebacks for the Product for chargeback requests for Product with an
invoice date prior to Closing.
10.8 Returns Seller or its Affiliates shall be responsible for any
qualified Product returns, consistent with its standard return policies, for all
Product sold or distributed prior to the Closing, and Buyer shall be responsible
for any qualified Product returns, consistent with its standard return policies,
for all Product sold or distributed on or after the Closing, except to the
extent such returns are due to manufacturing defects. Neither party will accept
returns for the account of the other party in unusual amounts or inconsistent
with its written return policies without first notifying the other party. If
either party or its Affiliate makes payment for Product returned for which the
other party is responsible, that other party will reimburse the paying party or
its Affiliate such amount within thirty (30) days following the date the paying
party or its Affiliate notifies the other that it or its Affiliate has made such
payments. For the purposes of this Section, "sold or distributed" means the
issuance of an invoice for Product shipped.
10.9 Cooperation Prior to the Closing, the parties agree to each
designate a key contact person or persons to work out further details and
procedures as the need may arise for each subsection in Article 10. These
contact persons shall be guided by the principles in Article 10, and the parties
agree to good faith cooperation in order to facilitate
28
the respective Covenants set forth in Article 10. It is understood that as a
part of these processes, Buyer will assume responsibility for administering
rebates, chargebacks and returns promptly following Closing, with priority in
the US and countries where Seller will not continue as distributor for the
Product.
11. CONDITIONS PRECEDENT TO CLOSING AND CLOSING
11.1 Conditions to Obligation of Buyer The obligations of Buyer under
this Agreement to complete the transactions contemplated hereby are subject to
the satisfaction on or prior to the Closing of the following conditions (all or
any of which may be waived by Buyer in whole or in part but such waiver shall be
in writing):
11.1.1 Representations and Warranties The representations and
warranties made by Seller in this Agreement shall have been true and
correct in all material respects as of the Closing with the same force
and effect as though said representations and warranties had been made
on the Closing.
11.1.2 Performance Seller shall have performed and complied in
all material respects with all agreements, obligations and conditions
required by this Agreement to be so performed or complied with by it
prior to or at Closing.
11.1.3 Consents All consents required under this Agreement
have been obtained.
11.1.4 No Material Change No material change shall have
occurred to the Assets or the prospects for the business related to the
Assets from the Effective Date to the Closing.
29
11.1.5 Financing Buyer shall have obtained financing approved
by its board of directors which is sufficient to make the upfront
payment called for by Section 4.1 of this Agreement.
11.1.6 SWITCH Trial Seller shall have provided Buyer with the
results of the SWITCH Trial.
11.2 Conditions to Obligations of Seller The obligations of Seller
under this Agreement to complete the transactions contemplated hereby are
subject to the satisfaction on or prior to the Closing of the following
conditions (all or any of which, except for Section 11.2.2(b), may be waived by
Seller in whole or in part but such waiver shall be in writing):
11.2.1 Representations and Warranties The representations and
warranties made by Buyer in this Agreement shall have been true and
correct in all material respects as of the Closing with the same force
and effect as though said representations and warranties had been made
on the Closing.
11.2.2 Performance Buyer shall have performed and complied in
all material respects with all agreements, obligations and conditions
required by this Agreement to be so performed or complied with by it
prior to or at Closing, including as related to Buyer having (a)
provided Seller, not later than thirty (30) days from the Effective
Date, with written evidence of Buyer's ability to finance the upfront
payment called for by Section 4.1 of this Agreement, and (b) Buyer
having obtained financing approved by its board of directors which is
sufficient to make that upfront payment.
11.2.3 No Material Change No material adverse change shall
have occurred to the financial condition of Buyer or the ability of
Buyer to conduct its obligations hereunder, from the Effective Date to
the Closing.
30
11.3 The Closing Subject to the satisfaction of all of the conditions
to each party's obligations set forth in Article 11 hereof (or, with respect to
any condition not satisfied, the waiver in writing thereof by the party or
parties for whose benefit the condition exists), the closing of the transactions
contemplated by this Agreement (the "Closing") shall take place as soon as
possible following the execution of this Agreement and satisfaction of
conditions to Closing as set forth in Sections 11.1 and 11.2 above (and no later
than [*] ([*]) days after Effective Date; or as otherwise mutually agreed
between the parties in writing) at offices of Seller or its Affiliate or at such
other time, date and place as the parties hereto may agree in writing. The
transfer of the Assets shall be deemed to have occurred as of the Closing Date.
11.4 Deliveries by Seller At Closing or within sixty (60) days
thereafter, Seller shall deliver to Buyer in form reasonably satisfactory to
Buyer, the Assets and executed assignments transferring ownership of the Assets,
in recordable form when necessary, and any other documents reasonably requested
by either party in order to carry out the intent of this Agreement.
Notwithstanding the preceding, with respect to Product Trademarks,
following the Closing, Buyer prepare and Seller shall execute documents required
in order to assign and record the assignment of the Product Trademarks. Seller
shall do all such deeds, actions and things as Buyer shall reasonably require in
order to effect the assignment of the Product Trademarks to Buyer and to effect
the recording of Buyer as registered proprietor thereof as soon as practically
possible, including, without prejudice to the generality of the foregoing,
requesting in writing that its local trademark agents co-operate with Buyer's
local trademark agents in relation thereto.
With respect to Finished Dosage Form Inventory transferred as an Asset
under Article 2.1, all shipments will be F.A.C. (Incoterm 2000) origin from
Seller's designated
31
distribution center(s). Shipping or freight, and any tariffs or duties, will be
paid by Buyer. Title and risk of loss will pass to Buyer upon delivery to
Buyer's designated common carrier at Seller's designated distribution center.
11.5 Deliveries by Buyer At Closing, Buyer shall deliver or cause to be
delivered to Seller the up-front payment in accordance with Section 4.1.
11.6 Delay of Closing If for any reason (other than breach of this
Agreement) the Closing does not occur by the time provided in Section 11.3, the
parties may in their sole discretion either mutually agree in writing to extend
the date of Closing, or either may terminate this Agreement upon written notice
to the other party, without liability or obligation.
11.7 Effect of Closing It is understood and agreed that all revenues
for sale of Product in the Territory prior to and following Closing shall be for
the account of Seller and Buyer, respectively, and the parties shall take such
actions and do all things necessary, including reconciling payments and reports,
in order to carry out this intent.
12. INDEMNIFICATION
12.1 Indemnification by Seller Subject to the limitations set forth in
Section 12.5 below, Seller shall indemnify Buyer and its Affiliates, and their
directors, officers, employees and agents ("Buyer Indemnitees") against, and
agrees to defend and hold each of the Buyer Indemnitees harmless from, any and
all damages, losses, liabilities, third party claims, and expenses
(collectively, "Damages") (including, without limitation, reasonable expenses of
investigation and attorneys' fees incurred or suffered by the Buyer Indemnitees)
arising out of (a) any inaccuracy in or breach of any representation, covenant,
agreement or warranty made by Seller herein, (b) the Retained Liabilities, (c)
any gross negligence or willful misconduct of Seller or its Affiliates, or (d)
the manufacture or supply of Product by Seller (collectively, "Buyer
Indemnifiable Claims").
32
12.2 Indemnification by Buyer Subject to the limitations set forth in
Section 12.5 below, Buyer shall indemnify Seller and its Affiliates, and their
directors, officers, employees and agents ("Seller Indemnitees") against, and
agrees to defend and hold each of the Seller Indemnitees harmless from, any and
all Damages (including, without limitation, reasonable expenses of investigation
and attorneys' fees incurred or suffered by the Seller Indemnitees) arising out
of (a) any inaccuracy in or breach of any representation, covenant, agreement or
warranty made by Buyer herein, (b) the Assumed Liabilities or (c) any gross
negligence or willful misconduct of Buyer or its Affiliates or partners,
sublicensees or distributors, or (d) any statement or representation
attributable to Buyer, its Affiliate, or partners, sublicensees or distributors
(other than Seller) or their directors, officers, employees and agents that is
inconsistent with or contrary to the Product Marketing Materials or Seller
Labeling (collectively "Seller Indemnifiable Claims").
12.3 Notice A party seeking indemnification pursuant to Section 12.1 or
12.2 above (an "Indemnified Party") shall give prompt notice to the party from
whom such indemnification is sought (the "Indemnifying Party") of the assertion
of any claim, or the commencement of any action, suit or proceeding, in respect
of which indemnity is or may be sought hereunder and will give the Indemnifying
Party such information with respect thereto as the Indemnifying Party may
reasonably request, but no failure to give such notice shall relieve the
Indemnifying Party of any liability hereunder except to the extent the
Indemnifying Party has suffered actual prejudice thereby.
12.4 Participation in Defense The Indemnifying Party may, at its
expense, participate in or assume the defense of any such action, suit or
proceeding involving a third party. In such case the Indemnified Party shall
have the right (but not the duty) to participate in the defense thereof, and to
retain counsel, at its own expense, separate from counsel retained by the
Indemnifying Party in any such action and to participate in the defense thereof.
The Indemnifying Party shall be liable for the fees and expenses of no more than
one firm retained as counsel by the Indemnified Party if the Indemnifying Party
33
has not assumed the defense thereof. Whether or not the Indemnifying Party
chooses to defend or prosecute any third party claim, the parties shall
cooperate in the defense or prosecution thereof and shall finish such records,
information and testimony as may be reasonably requested in connection
therewith. In no event shall any third party claim be settled by the Indemnified
Party without the prior written consent of the Indemnifying Party.
12.5 Limitations on Indemnity Notwithstanding anything to the contrary
set forth elsewhere herein, neither the Buyer Indemnitees or the Seller
Indemnitees shall be entitled to indemnification hereunder unless the
Indemnified Party transmits written notice of a claim for indemnification to the
Indemnifying Party no later than six (6) months after receipt of a written claim
or threat which could result in a claim.
12.6 No Special Damages IN NO EVENT SHALL EITHER, PARTY BE LIABLE TO
THE OTHER PARTY FOR ANY LOST PROFITS OR PUNITIVE, SPECIAL, INCIDENTAL, INDIRECT
OR CONSEQUENTIAL DAMAGES, EXCEPT THAT THE FOREGOING LIMITATION SHALL NOT APPLY
TO ANY LOST PROFITS OR PUNITIVE DAMAGES THAT MAY BE AWARDED TO A THIRD PARTY AND
FOR WHICH A PARTY OTHERWISE IS LIABLE TO PROVIDE INDEMNIFICATION UNDER THIS
ARTICLE 12.
13. NOTICES
Any notice required or permitted to be given hereunder shall be deemed
sufficient if sent by United States mail or overnight courier, or delivered by
hand to Seller or Buyer at the respective addresses set forth below or at such
other address as either party hereto may designate. If delivered by overnight
courier, notice shall be deemed given when it has been signed for. If delivered
by hand, notice shall be deemed given when received. If delivered by U.S. Mail,
notice shall be deemed given five (5) business days following the postmark date.
34
If to Buyer, to:
AMARIN CORPORATION, plc
0 Xxxxxx Xxxxxx
Xxxxxx X0X 0XX
Xxxxxx Xxxxxxx
Attention: General Counsel and Corporate Secretary
With a copy to:
AMARIN CORPORATION
Xxx Xxxxxxxxx Xxxxx, Xxxxx 000
Xxxx Xxxxxx, Xxxxxxxxxx 00000
Attention: Executive Vice President, Commercial Development
If to Seller, to:
XXXXXXXX-XX XXXXX INC.
000 Xxxxxxxxx Xxxxxx
Xxxxxx, Xxx Xxxxxx 00000
Attention: Corporate Secretary
and
X.XXXXXXXX-XX XXXXX LTD
Xxxxxxxxxxxxxxxxx 000
XX-0000 Xxxxx Xxxxxxxxxxx
Attn: Corporate Law
14. GOVERNING LAW AND ARBITRATION
This Agreement shall be governed by the laws of Switzerland, without
reference to its conflict of laws principles.
35
Unless otherwise set forth in this Agreement, in the event of any dispute
in connection with this Agreement, such dispute shall be referred to the
respective executive officers of the parties designated below or their
designees, for good faith negotiations attempting to resolve the dispute. The
designated executive officers are as follows:
For Buyer: CEO
For Seller: Head of Pharma
Should the parties fail to agree within two (2) months after such dispute
has first arisen, it shall be finally settled by arbitration in accordance with
the commercial arbitration rules of the International Chamber of Commerce as in
force at the time when initiating the arbitration. The tribunal shall consist of
three arbitrators. The place of arbitration shall be Basel, Switzerland. The
language to be used shall be English. Each party shall bear its own costs of
arbitration, and shall share the costs of arbitrators equally, unless costs are
allocated otherwise by the arbitrators.
15. ADDITIONAL TERMS
15.1 Brokers Buyer represents to Seller that it has not employed any
investment banker, broker, finder or intermediary in connection with the
transactions contemplated hereby who might be entitled to a fee or any
commission from Seller upon consummation of the transactions contemplated
hereby. Seller represents to Buyer that it has not employed any such Person in
such connection who might be entitled to a fee or any commission from Buyer upon
consummation of the transactions contemplated hereby.
15.2 Expenses Except as otherwise expressly provided in this Agreement,
all legal, accounting and other costs and expenses incurred in connection
herewith and the transactions contemplated hereby shall be paid by the party
incurring such expenses.
36
15.3 Successors and Assigns This Agreement shall be binding upon and
shall inure to the benefit of the parties and their respective successors and
assigns (including, for sake of clarification, successors by merger or asset
acquisition). For Buyer, this Agreement may not be assigned in whole or in part
other than to an Affiilate without the prior written consent of Seller. For
Seller, until December 31, 2004 this Agreement may not be assigned in whole or
in part without the prior written consent of Buyer other than to an Affiliate.
In the event of an assignment under this Section 15.3, the assigning party and
the assignee shall be jointly and severally liable for the performance of the
obligations on the part of the assigning party set out in this Agreement.
15.4 Exhibits and Schedules The Exhibits and Schedules attached to this
Agreement are accurate and complete as of the Effective Date. Those Exhibits and
Schedules, and the principles and conditions incorporated in such Exhibits and
Schedules, shall be deemed integral parts of this Agreement and all references
in this Agreement to this Agreement shall encompass such Exhibits and Schedules
and the principles and conditions incorporated in such Exhibits and Schedules.
15.5 Entire Agreement This Agreement and the exhibits hereto embody the
entire agreement of the parties hereto with respect to the subject matter hereof
and supersede and replace all previous negotiations, understandings,
representations, writings, and contract provisions and rights relating to the
subject matter hereof.
15.6 Amendments; No Waiver No provision of this Agreement may be
amended, revoked or waived except by a writing signed and delivered by an
authorized officer of each party. No failure or delay on the part of either
party in exercising any right hereunder will operate as a waiver of, or impair,
any such right. No single or partial exercise of any such right will preclude
any other or further exercise thereof or the exercise of any other right. No
waiver of any such right will be deemed a waiver of any other right hereunder.
37
15.7 Counterparts This Agreement may be executed in one or more
counterparts all of which shall together constitute one and the same instrument
and shall become effective when a counterpart has been signed by Buyer and
delivered to Seller and a counterpart has been signed by Seller and delivered to
Buyer.
15.8 Severability The parties agree that (a) the provisions of this
Agreement shall be severable and (b) in the event that any of the provisions
hereof are held by a court of competent jurisdiction to be invalid, void, or
otherwise unenforceable, (i) such invalid, void or otherwise unenforceable
provisions shall be automatically replaced by other provisions that are as
similar as possible in terms to such invalid, void or otherwise unenforceable
provisions but are valid and enforceable and (ii) the remaining provisions shall
remain enforceable to the fullest extent permitted by law, provided that the
rights and interests of the parties hereto shall not be materially affected.
15.9 Captions Captions herein are inserted for convenience of reference
only and shall be ignored in the construction or interpretation of this
Agreement. Unless the context requires otherwise, all references herein to
Articles and Sections are to the articles and sections of this Agreement.
15.11 Force Majeure Failure of either Buyer or Seller to perform its
obligations under this Agreement (except the obligation to make payments when
properly due) shall not subject such party to any liability or place them in
breach of any term or condition of this Agreement to the other party to the
extent that such failure is due to fire, explosion, flood, drought, war, riot,
sabotage, embargo, strikes or other labor trouble, a national health emergency,
compliance with any order or regulation of any government entity acting with
color of right, or any other cause beyond the reasonable control of such
non-performing party (such event or cause referred to as "force majeure"). The
party affected shall promptly notify the other party of the condition
constituting force majeure as defined herein and shall use diligent efforts to
eliminate, cure or overcome any such event of force majeure and to resume
performance of its obligations with all possible speed. If a condition
38
constituting force majeure as defined herein exists for more than ninety (90)
consecutive days, the parties shall meet to negotiate a mutually satisfactory
resolution to the problem, if practicable.
39
IN WITNESS WHEREOF, this Agreement has been signed by duly authorized
representatives of each of the parties hereto as of the date first above
written.
XXXXXXXX-XX XXXXX INC. AMARIN CORPORATION plc
By: /s/ Xxxxxx Xxxxx By: /s/ Xxxxxxx X. X. Xxxxxxx
Name: Xxxxxx Xxxxx Name: Xxxxxxx X. X. Xxxxxxx
Title: Title: Chief Executive Officer
-------------------------
Date: Date:
------------------------- -------------------------
X.XXXXXXXX-XX XXXXX LTD
By: /s/ Xxxxxxx X. Xxxxxx
Name: Xxxxxxx X. Xxxxxx
Title:
-------------------------
Date:
-------------------------
By: /s/ Xxxxxx Xxxxxxxxx
Name: Xxxxxx Xxxxxxxxx
Title:
-------------------------
Date:
-------------------------
128075
40
SCHEDULE 1.21
MANUFACTURING TECHNOLOGY
[TO BE PROVIDED PRIOR TO CLOSING]
41
SCHEDULE 1.24
PATENTS
PATENT STATUS FOR TASMAR(R) (TOLCAPONE)
1. PRODUCT-PROTECTION (CASE 10216)
COUNTRY APPL.DT. XXXX.XX. XXXXX XX PATENT NO. EXPIRY HOLDER STAT
------- -------- -------- -------- ---------- ------ ------ ----
Argentina AR 09.03.1987 306966 30.12.1993 245097 30.12.2008 Roche Basel P
Argentina AR1 26.12.1995 334796 11.03.2007 Roche Basel A
Australia AU 06.03.1987 69764/87 10.04.1991 603788 06.03.2007 Roche Basel P
Austria AT 11.03.1987 87103469.0 02.06.1993 E 90072 11.03.2007 Roche Basel P
Austria AT1 24.11.1997 XX 00/00 Xxxxx Xxxxx A
Bahrain BH 29.07.1996 1272/96 28.06.1998 BP1120 29.07.2011 Roche Basel P
Belgium BE 11.03.1987 87103469.0 02.06.1993 0237929 11.03.2007 Roche Basel P
Belgium BE1 05.12.1997 097CO112 Roche Basel A
Brazil BR 23.09.1996 PI1100051.1 25.05.1999 PI1100051.1 11.03.2007 Roche Basel P
Bulgaria BG 16.07.1992 96626 16.01.1995 60383 17.08.2010 Roche Nutley P
Canada CA 20.02.1987 530171 02.06.1992 1302418 02.06.2009 Roche Basel P
Chile CL 04.03.1987 124/87 30.08.1988 36172 30.08.2003 Roche Basel P
Denmark DK 18.02.1987 820/87 18.02.2007 Roche Basel A
42
COUNTRY APPL.DT. XXXX.XX. XXXXX XX PATENT NO. EXPIRY HOLDER STAT
------- -------- -------- -------- ---------- ------ ------ ----
Dominican DO 29.07.1996 04.03.2007 Roche Basel A
Finland FI 10.03.1987 871041 27.06.1994 91396 10.03.2007 Roche Basel P
Finland FI1 28.10.1997 L 1997 0021 06.06.2001 118 09.03.2012 Roche Basel P
France FR 11.03.1987 87103469.0 02.06.1993 0237929 11.03.2007 Roche Basel P
France FR1 13.11.1997 97C00127 14.04.2000 00/15 25.02.2012 Roche Basel P
Germany DE 18.12.1997 19775095.8 22.04.1998 19775095.8 11.03.2012 Roche Basel P
Germany DE1 18.12.1997 19775095.8 22.04.1998 19775095.8 11.03.2012 Roche Basel P
Greece GR 11.03.1987 87103469.0 02.06.1993 3008958 11.03.2007 Roche Basel P
Greece GR1 17.02.1998 980800005 16.10.1998 8000005 17.02.2018 Xxxxx Xxxxx X
Xxxx Xxxx XX 05.09.1996 1658/96 05.09.1996 1658/96 11.03.2007 Roche Basel P
Hungary HU 09.03.1987 989/87 16.10.1990 201900 09.03.2007 Roche Basel P
Iran IR 23.04.1988 27822 30.04.1988 23643 09.03.2007 Roche Basel P
Ireland IE 10.03.1987 609/87 20.10.1994 61316 10.03.2007 Roche Basel P
Ireland IE1 10.11.1997 SPC 28/97 03.08.1999 SPC 61316 24.02.2012 Roche Basel P
Israel IL 05.03.1987 81791 31.03.1993 81791 05.03.2007 Roche Basel P
Italy IT 11.03.1987 87103469.0 02.06.1993 0237929 11.03.2007 Roche Basel P
Italy IT1 09.12.1997 351808 21.01.1998 C-UB97CCP602 11.03.2012 Roche Basel P
Latvia LV 29.05.1996 P 162/96 20.12.1996 5742 11.03.2007 Roche Basel P
43
COUNTRY APPL.DT. XXXX.XX. XXXXX XX PATENT NO. EXPIRY HOLDER STAT
------- -------- -------- -------- ---------- ------ ------ ----
Luxembourg LU 11.03.1987 87103469.0 02.06.1993 0237929 11.03.2007 Roche Basel P
Luxembourg LU1 19.11.1997 90172 21.01.1998 90172 11.03.2012 Roche Basel P
Luxembourg LU2 25.02.1998 90219 28.05.1998 90219 25.02.2012 Roche Basel P
Mexico MX 26.06.1992 9203634 13.01.1997 183747 09.01.2007 Roche Basel P
Monaco MC 09.03.1987 1876/87 22.12.1987 87.1807 09.03.2007 Roche Basel P
Netherlands NL 11.03.1987 87103469.0 02.06.1993 0237929 11.03.2007 Roche Basel P
Netherlands NL1 21.11.1997 970041 21.04.1998 970041 10.03.2012 Roche Basel P
New Zealand NZ 04.03.1987 219496 22.04.1991 219496 04.03.2007 Roche Basel P
Norway NO 10.03.1987 19870984 08.05.1991 165959 10.03.2007 Roche Norge P
Norway NO1 28.01.1998 SPC 006/98 06.03.1998 SPC/NO 1998006 10.03.2012 Roche Basel P
Panama PA 14.10.1996 083492 16.03.1999 083492 04.03.2007 Roche Basel P
Paraguay PY 25.01.2001 01436 20.12.2001 4066 11.03.2007 Roche Basel P
Philippines PH 10.03.1987 34997 04.12.2000 0-0000-00000 04.12.2017 Roche Basel P
Philippines PH1 12.04.1988 36785 28.04.2000 0-0000-00000 Roche Basel P
Philippines PH2 14.07.2000 0-0000-00000 16.04.2002 0-0000-00000 16.04.2019 Roche Basel P
Philippines PH3 14.07.2000 0-0000-00000 16.04.2002 0-0000-00000 16.04.2019 Roche Basel P
Philippines PH4 14.07.2000 0-0000-00000 16.04.2002 0-0000-00000 16.04.2019 Roche Basel P
Portugal PT 11.03.1987 84449 17.03.1989 84449 17.03.2007 Roche Basel P
Portugal PT1 15.01.1998 2/98 Roche Basel A
44
COUNTRY APPL.DT. XXXX.XX. XXXXX XX PATENT NO. EXPIRY HOLDER STAT
------- -------- -------- -------- ---------- ------ ------ ----
Romania RO 18.09.1998 C-20218 31.10.2002 2.246T 11.03.2007 Roche Basel P
Saudi SA 25.09.1996 96170326 Roche Basel A
Singapore SG 10.07.1996 9691659.8 15.08.1996 9691659.8 11.03.2007 Roche Basel P
South Africa ZA 04.03.1987 1564/87 28.10.1987 1564/87 04.03.2007 Roche Basel P
South Korea KR 09.03.2987 2089/87 19.05.1993 62090 09.03.2007 Roche Nutley P
South Korea KR1 01.07.1987 6864/87 15.11.1996 107730 16.07.2011 Roche Nutley P
Spain ES 11.03.1987 87103469.0 02.06.1993 0237929 11.03.2007 Roche Basel P
Spain ES1 15.01.1998 C9800002 Roche Basel A
Sweden SE 11.03.1987 87103469.0 02.06.1993 87103469.0 11.03.2007 Roche Basel P
Sweden SE1 03.11.1997 9790043-5 05.10.1998 9790043-5 24.02.2012 Roche Basel P
Switzerland CH3 11.03.1987 87103469.0 02.06.1993 0237929 11.03.2007 Roche Basel P
Switzerland CH2 21.05.1997 CO237929/01 31.07.1998 CO237929/01 25.02.2012 Roche Basel P
Taiwan TW1 17.02.1987 76100779 12.03.1991 NI 42821 16.02.2007 Roche Basel P
United GB 11.03.1987 87103469.0 02.06.1993 0237929 11.03.2007 Roche Basel P
United GB1 13.11.1997 SPC/GB97/088 17.12.1998 SPC/GB97/088 24.02.2012 Roche Basel P
Uruguay UY 10.03.1987 22585 16.08.1991 13213 10.03.2007 Roche Basel P
USA US2 16.04.1991 07/686210 17.08.1993 5236952 29.01.2012 Roche Nutley P
USA US3 16.04.1993 08/048685 14.02.1995 5389653 14.02.2012 Roche Nutley P
USA US4 21.10.1994 08/327160 19.12.1995 5476875 19.12.2012 Roche Nutley P
45
COUNTRY APPL.DT. XXXX.XX. XXXXX XX PATENT NO. EXPIRY HOLDER STAT
------- -------- -------- -------- ---------- ------ ------ ----
USA US5 15.09.1995 08/528588 27.05.1997 5633371 06.03.2007 Roche Nutley P
USA US6 21.01.1997 08/784554 06.01.1998 5705703 06.05.2007 Roche Nutley P
46
2. PROCESS-PROTECTION(CASE 20218)
COUNTRY APPL.DT. XXXX.XX. XXXXX XX PATENT NO. EXPIRY HOLDER STAT
------- -------- -------- -------- ---------- ------ ------ ----
Argentina AR 19.01.1998 P980100218 19.01.2018 Roche Basel A
Australia AU 16.01.1998 52102/98 30.08.2001 733422 16.01.2018 Roche Basel P
Austria AT 15.01.1998 98100582.0 05.09.2001 E205177 15.01.2018 Roche Basel P
Belgium BE 15.01.1998 98100582.0 05.09.2001 0855379 15.01.2018 Roche Basel P
Brazil BR 21.01.1998 PI9800426.3 21.01.2018 Roche Basel A
Canada CA 15.01.1998 2227131 15.01.2018 Roche Basel A
China CN 21.01.1998 98104299.6 09.10.2002 ZL98104299.6 21.01.2018 Roche Basel P
Denmark DK 15.01.1998 98100582.0 05.09.2001 0855379 15.01.2018 Roche Basel P
Finland FI 15.01.1998 98100582.0 05.09.2001 0855379 15.01.2018 Roche Basel P
France FR 15.01.1998 98100582.0 05.09.2001 0855379 15.01.2018 Roche Basel P
Germany DE 15.01.1998 98100582.0 05.09.2001 69801532.0 15.01.2018 Roche Basel P
Greece GR 15.01.1998 98100582.0 05.09.2001 3037446 15.01.2018 Roche Basel P
Indonesia ID 15.04.1997 P-971255 09.09.2002 15.04.2012 Roche Basel P
Ireland IE 15.01.1998 98100582.0 05.09.2001 0855379 15.01.2018 Roche Basel P
Italy IT 15.01.1998 98100582.0 05.09.2001 0855379 15.01.2018 Roche Basel P
Luxembourg LU 15.01.1998 98100582.0 05.09.2001 0855379 15.01.2018 Roche Basel P
47
COUNTRY APPL.DT. XXXX.XX. XXXXX XX PATENT NO. EXPIRY HOLDER STAT
------- -------- -------- -------- ---------- ------ ------ ----
Mexico MX 21.01.1998 980608 08.06.2001 202252 21.01.2018 Roche Basel P
Netherlands NL 15.01.1998 98100582.0 05.09.2001 0855379 15.01.2018 Roche Basel P
Portugal PT 15.01.1998 98100582.0 05.09.2001 0855379 15.01.2018 Roche Basel P
South Africa ZA 15.01.1998 98/0347 30.09.1998 98/0347 15.01.2018 Roche Basel P
South Korea KR 20.01.1998 98-1483 13.07.2000 268545 Roche Basel P
Spain ES 15.01.1998 98100582.0 05.09.2001 0855379 15.01.2018 Roche Basel P
Sweden SE 15.01.1998 98100582.0 05.09.2001 0855379 15.01.2018 Roche Basel P
Switzerland CH1 15.01.1998 98100582.0 05.09.2001 0855379 15.01.2018 Roche Basel P
Turkey TR 16.01.1998 98/68 16.01.2018 Xxxxx Xxxxx X
Xxxxxx X. XX 15.01.1998 98100582.0 05.09.2001 0855379 15.01.2018 Roche Basel P
USA US 15.01.1998 09/007612 02.03.1999 5877353 15.01.2018 Roche Nutley P
A=Patent Application
P=Granted Patent
48
SCHEDULE 1.28
PRODUCT REGISTRATIONS
COUNTRY REGISTRATION DATE INTRODUCTION DATE COMMENT
Argentina 08-Aug-1997 29-Aug-1997 Marketed
Aruba 04-Feb-1998 Marketed
Brazil 12-Jan-1998 26-Mar-1998 Marketed
Chile 09-Dec-1997 10-Dec-1997 Marketed
Colombia 06-Apr-1998 (100 mg) 01-May-1998 Marketed
20-Jan-1998 (200 mg) 00-Xxx-0000
Xxxxx Xxxx Marketed
Cuba 19-Aug-1997 Marketed
Curacao 19-Aug-1997 Marketed
Cyprus 19-Aug-97 Marketed
Dominican Rep. 23-Jan-1998 Marketed
Ecuador 19-Feb-1998 (100 mg) 12-Jun-1998 Marketed
15-Apr-1998 (200 mg)
Xx Xxxxxxxx 00-Xxx-00 Xxxxxxxx
Xxxxxxx 24-Oct-1997 Marketed
Guatemala 29-Oct-1997 Streamlined August 13, 2001 Marketed
Honduras 05-Aug-1998 Marketed
Hongkong 31-Jul-1998 10-Aug-1998 Marketed
Latvia 21-Jul-1998 Marketed
Lebanon 1998 Marketed
New Zealand 18-Dec-1997 15-Feb-1998 Marketed
(only 100 mg)
Nicaragua 18-Feb-1998 Marketed
49
COUNTRY REGISTRATION DATE INTRODUCTION DATE COMMENT
Norway 12.01.1998(Suspended on Sept Jan-98 Available on
1, 2000 as per EU trety) special licence
Panama 24-Mar-1998 Marketed
Paraguay 1998 Marketed
Philippines 9-Jan-98 29-Jun-1998 Marketed
(only 100 mg)
Romania 28-Jan-1998 Marketed
Singapore 25-May-1998 18-Jun-1998 (100 mg) Marketed
25-Jun-1998 (200 mg)
South Africa 16-Apr-1998 (only 100 mg) 05-May-1998 Marketed
Switzerland 25-Feb-1997 15-Sep-1997 Marketed
Trinidad/Tobago 13-Jan-1998 Marketed
Uruguay 30-Sep-1997 01-Oct-1997 Marketed
USA 29-Jan-1998 16-Feb-1998 Marketed
Yugoslavia 03-Dec-1997 05-Mar-1998 Marketed
Barbados Marketed
Bermudas Marketed
Bolivia Marketed
Bosnia-Herzegovia Marketed
Dutch Antilles Marketed
Egypt Marketed
Faeroe Marketed
Haiti Marketed
Israel Marketed
St. Xxxxxxx Marketed
50
Swaziland Marketed
Zimbabwe Marketed
Ukraine Marketed
Additional current information on Registrations in the Major Countries is as
follows:
Canada
[*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*]
France
[*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*]
Germany
[*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*]
Italy
[*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*]
51
SPAIN
[*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*]
U.S.A.
[*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*]
UNITED KINGDOM
[*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*]
Additional information on Registrations in countries other than the Major
Countries, from which the above chart is taken, is contained in an email
attachment forwarded from Seller to Buyer on March 6, 2003.
52
SCHEDULE 1.29
PRODUCT TRADEMARKS
COUNTRY TRADEMARK FILING DATE FILING NO. XXX.XX. RENEWAL NO. REGISTERED OWNERS
------- --------- ----------- ---------- ------- ----------- -----------------
ARGENTINA TASMAR 16/10/1990 1570154 ROCHE BASLE
ARGENTINA ROSMAR 27/05/1994 1589566 ROCHE BASLE
AUSTRALIA TASMAR 29/08/1975 A290172 ROCHE PRODUCTS LTD. WELWYN
BOLIVIA TASMAR A50261 ROCHE XXXXXXXX HLRP
BRAZIL TASMAR 28/03/1995 818396741 818396741 XXXXX XXXXX
XXXXXXX XXXXXX XXX0000 XXX0000 XXXXX XXXXX
XXXXXX TASMAR 09/03/1995 000000 XXXXX XXXXXXXXXXX, XXXXXX
CHILE TASMAR 466475 ROCHE HAMILTON HLRP
CHINA TASMAR 18/09/1995 984859 ROCHE BASLE
CHINA TASMAR 09/08/1995 1015093 ROCHE BASLE
CHINA TASMAR 08/08/1996 1099709 ROCHE BASLE
COLOMBIA TASMAR 28/04/1987 128688 ROCHE XXXXXXXX HLRP
CONGO DEM. REP. TASMAR 10/02/1997 0000/00 XXXXX XXXXX
XXXXX XXXX TASMAR 29/04/1980 58037 00000 XXXXX XXXXXXXX XXXX
XXXXX XXXX TASMAR 25/05/1995 94056 ROCHE XXXXXXXX HLRP
53
CYPRUS GREEK TASMAR 26/07/1978 19029 19029 ROCHE BASLE
CYPRUS TURKISH TASMAR 25/09/1978 567 000 XXXXX XXXXX
XXXXXXX TASMAR 1295/1977 ROCHE BASLE
DOM. REP. TASMAR 28248 28248 ROCHE XXXXXXXX RIL
ECUADOR TASMAR 11/10/1976 2446-97 ROCHE XXXXXXXX RIL
EIRE TASMAR 04/10/1976 89918 ROCHE PRODUCTS LTD. WELWYN
ESTONIA TASMAR 14/01/1997 26527 ROCHE BASLE
FINLAND TASMAR 74465 74465 ROCHE BASLE
GEORGIA TASMAR 24/01/1997 9868 ROCHE BASLE
GREAT BRITAIN TASMAR 18/09/1975 1052252 ROCHE PRODUCTS LTD. WELWYN
GREECE TASMAR 01/10/1976 57454 ROCHE BASLE
GUATEMALA TASMAR 34230 ROCHE XXXXXXXX HLRP
HAITI TASMAR 243/83 127/119 ROCHE XXXXXXXX HLRP
HONDURAS TASMAR 24276 ROCHE XXXXXXXX HLRP
HONG KONG TASMAR 10/03/1995 6516/1996 0000/0000 XXXXX XXXXX
XXXX XXXX XXXXXX 11/08/1995 11352/1996 00000/0000 XXXXX XXXXX
XXXX XXXX XXXXXX 11/08/1978 463/1979 000/0000 XXXXX XXXXX
XXXX XXXX XXXXXX 30/07/1996 7499/1997 ROCHE BASLE
ICELAND TASMAR 03/08/1995 146/1996 ROCHE BASLE
INDIA TASMAR 04/09/1975 308206 ROCHE BASLE
INDONESIA TASMAR 03/07/1997 414162 ROCHE BASLE
54
IRAN TASMAR 31/10/1976 47071 ROCHE BASLE
IRAQ TASMAR 16/10/1976 00000 XXXXX XXXXX
XXXXXX TASMAR 24/07/1978 46295 46295 ROCHE BASLE
ISRAEL TASMAR 09/03/1995 97496 97496 ROCHE BASLE
ITALY TASMAR 09/08/1979 375813 ROCHE BASLE
JAMAICA TASMAR 28/01/1997 5/6546 ROCHE BASLE
JAMAICA TASMAR 14/09/1978 18911 18911 ROCHE BASLE
JORDAN TASMAR 08/08/1978 00000 XXXXX XXXXX
XXXXX TASMAR 24/08/1978 25193 25193 ROCHE PRODUCTS LTD. WELWYN
KOREA SOUTH TASMAR 09/05/1995 95-17956 341886 ROCHE BASLE
KOREA SOUTH TASMAR 20/09/1990 90-28267 230366 230366 ROCHE BASLE
KUWAIT TASMAR 26/09/1978 0000 XXXXX XXXXX
XXXXXXX XXXXXX 09/05/1977 33504 57622 ROCHE BASLE
LIBYA TASMAR 07/12/1978 9136/XX XXXXX BASLE
LITHUANIA TASMAR 20/01/1997 97-0146 32216 ROCHE BASLE
MALAWI TASMAR 03/08/1978 000/00 XXXXX XXXXX
XXXXXXXX TASMAR 12/08/1978 M/79573 M/079573 ROCHE PRODUCTS LTD. WELWYN
MALTA TASMAR 28/08/1978 13560 ROCHE PRODUCTS LTD. WELWYN
MEXICO TASMAR 21/09/1990 402164 402164 ROCHE XXXXXXXX RIL
NEW ZEALAND TASMAR 14/08/1992 220617 ROCHE BASLE
NICARAGUA TASMAR 23/05/1995 CC29935 ROCHE XXXXXXXX RIL
00
XXXXXXXXX TASMAR CC7876 ROCHE XXXXXXXX RIL
NIGERIA TASMAR 11/09/1978 33792 33792 ROCHE PRODUCTS LTD. WELWYN
NORWAY TASMAR 98847 ROCHE BASLE
O.A.P.I. TASMAR 15/11/1976 16621 ROCHE BASLE
OMAN TASMAR 18/01/1997 00000 XXXXX XXXXX
XXXXXXXX TASMAR 08/08/1978 67931 67931 XXXXX XXXXX
XXXXXX XXXXXX 00000 ROCHE XXXXXXXX HLRP
PARAGUAY ROASMAR 16/06/1995 185156 ROCHE BASLE
PARAGUAY ROSMAR 16/06/1995 185157 XXXXX XXXXX
XXXX XXXXXX 00000 66617 ROCHE XXXXXXXX RIL
PHILIPPINES TASMAR 01/06/1995 100501 ROCHE BASLE
POLAND TASMAR 01/08/1995 102444 ROCHE XXXXX
XXXXXX XXXXXX XXX0000 CRK1449 ROCHE BASLE
SALVADOR TASMAR 00-00 00 XXXXX XXXXXXXX XXXX
XXXXX XXXXXX TASMAR 08/09/1990 234/71 000/00 XXXXX XXXXX
XXXXXXXXX TASMAR 10/08/1978 76961 T78/76961G ROCHE PRODUCTS LTD. WELWYN
SOMALIA TASMAR 17/09/1978 0000 XXXXX XXXXX
XXXXX XXXXXX TASMAR 04/09/1975 00/0000 XXXXX XXXXX
XXX XXXXX TASMAR 08/08/1978 39249 39249 ROCHE XXXXX
XXXXXXXX XXXXXX 0000 0000 XXXXX XXXXX
XXXXXX TASMAR 15/03/1995 308741 ROCHE XXXXX
00
XXXXXX TASMAR 164488 ROCHE BASLE
SWITZERLAND TASMAR 23/07/1991 000000 XXXXX XXXXX
XXXXXXXXXXX TASMAR 18/08/1975 P278372 XXXXX XXXXX
XXXXX XXXXXX 00000 ROCHE BASLE
THAILAND TASMAR 13/09/1978 81496 ROCHE BASLE
TRINIDAD AND TOBAGO TASMAR 23/08/1978 10904 ROCHE PRODUCTS LTD. WELWYN
TUNISIA TASMAR 30/10/1995 EE.95.1424 ROCHE BASLE
TURKEY TASMAR 22/12/1975 00000 XXXXX XXXXX
XXXXXX XXXX XXXXXX 12/02/1997 20250 16729 ROCHE BASLE
EMIRATES
URUGUAY TASMAR 287000 ROCHE XXXXXXXX RIL
USA TASMAR 15/03/1995 2029225 ROCHE NUTLEY
VENEZUELA TASMAR 85967-F 00000-X XXXXX XXXXXXXX XXXX
XXXXX (XXXXXXXX OF) TASMAR 18/09/1975 0000/X XXXXX XXXXX
XXXXXX TASMAR 09/08/1978 227/78 ROCHE PRODUCTS LTD. WELWYN
ZIMBABWE TASMAR 24/07/1978 430/78 ROCHE BASLE
INTERNATIONAL
PROCEDURE TASMAR 31/10/1975 R418943 R418943 ROCHE BASLE
--------- ------ ---------- ------- ------- -----------
ALGERIA TASMAR 31/10/1975 R418943 R418943 ROCHE BASLE
ARMENIA TASMAR 31/10/1995 R418943 R418943 XXXXX XXXXX
00
XXXXXXX XXXXXX 31/10/1975 R418943 R418943 ROCHE BASLE
BELARUS TASMAR 31/10/1995 R418943 R418943 ROCHE BASLE
BENELUX TASMAR 31/10/1975 R418943 R418943 ROCHE BASLE
BOSNIA-HERZEGOVINA TASMAR 31/10/1995 R418943 R418943 ROCHE BASLE
BULGARIA TASMAR 20/07/1987 R418943 R418943 ROCHE BASLE
CROATIA TASMAR 31/10/1975 R418943 R418943 ROCHE BASLE
CZECHIA TASMAR 31/10/1975 R418943 R418943 ROCHE BASLE
EGYPT TASMAR 31/10/1975 R418943 R418943 ROCHE BASLE
FRANCE TASMAR 31/10/1975 R418943 R418943 ROCHE BASLE
GERMANY TASMAR 31/10/1975 R418943 R418943 ROCHE BASLE
HUNGARY TASMAR 31/10/1975 R418943 R418943 ROCHE BASLE
ITALY TASMAR 31/10/1975 R418943 R418943 ROCHE BASLE
KAZAKHSTAN TASMAR 31/10/1995 R418943 R418943 ROCHE BASLE
KIRGIZSTAN TASMAR 31/10/1995 R418943 R418943 ROCHE BASLE
LATVIA TASMAR 31/10/1995 R418943 R418943 ROCHE BASLE
LIECHTENSTEIN TASMAR 31/10/1975 R418943 R418943 ROCHE BASLE
MACEDONIA TASMAR 31/10/1975 R418943 X000000 XXXXX XXXXX
XXXXXXX (REP) TASMAR 31/10/1995 R418943 R418943 ROCHE BASLE
MONACO TASMAR 31/10/1975 R418943 R418943 ROCHE BASLE
MOROCCO TASMAR 31/10/1975 R418943 R418943 ROCHE BASLE
PORTUGAL TASMAR 31/10/1975 R418943 R418943 XXXXX XXXXX
00
XXXXXXX TASMAR 31/10/1975 R418943 R418943 ROCHE BASLE
RUSSIA TASMAR 31/10/1995 R418943 R418943 ROCHE BASLE
SAN MARINO TASMAR 31/10/1975 R418943 R418943 ROCHE BASLE
SLOVAKIA TASMAR 31/10/1975 R418943 R418943 ROCHE BASLE
SLOVENIA TASMAR 31/10/1975 R418943 R418943 ROCHE BASLE
SPAIN TASMAR 31/10/1975 R418943 R418943 ROCHE BASLE
SUDAN TASMAR 20/07/1987 R418943 R418943 ROCHE BASLE
TADJIKISTAN TASMAR 31/10/1995 R418943 R418943 ROCHE BASLE
UKRAINE TASMAR 31/10/1995 R418943 R418943 ROCHE BASLE
UZBEKISTAN TASMAR 31/10/1995 R418943 R418943 ROCHE BASLE
VIETNAM TASMAR 31/10/1975 R418943 R418943 ROCHE BASLE
YUGOSLAVIA TASMAR 31/10/1975 R418943 R418943 ROCHE BASLE
59
SCHEDULE 5.1
INVENTORY
FINISHED DOSAGE FORM INVENTORY
------------------------------
DOSAGE PACK SIZE MARKET # OF PACKS
------ --------- ------ ----------
[*] [*] [*] [*]
Bulk Tablet Inventory - As of January 31, 2003, Seller has in its possession or
control a Bulk Tablet Inventory in 100 mg tablet dosage form of about [*] ([*]),
stored in Switzerland and having expiration dating no earlier than 30 November,
200[*]. Active Pharmaceutical Ingredient - Inventory as of January 31, 2003 is a
total of approximately [*] tons, milled and unmilled, as provided in due
diligence investigation conducted by Seller, sufficient to produce: Tasmar film
coated tablets 100 MG: [*] Million units; Tasmar film coated tablets 200 MG: [*]
Million units.
60
SCHEDULE 5.1(b)
COUNTRY GROUPING FOR MOQ
[*] [*] [*] [*] [*] [*] [*] [*] [*] [*]
---- ------------ ------------ ------------------ --------- ----- -------- -------------- ----------------
[*] [*] [*] [*] [*] [*] [*] [*] [*] [*]
61
SCHEDULE 5.3
COST
Pack size (number of Total Cost per pack
Dosage (mg) tablets/blister or bottle) (US Dollars)
----------- -------------------------- -------------------
[*] [*] [*]
63
SCHEDULE 6.9
LITIGATIONS
PENDING NEGOTIATIONS WITH XXXXX CONCERNING TRADEMARK APPLICATION FOR TAJAMAR
(ARGENTINA)
PENDING MEDIATION WITH ROEMMERS CONCERNING THE TRADEMARK APPLICATION FOR TEMAR
(ARGENTINA)
64
