License Agreement for Levocetirizine - UCB Farchim SA and Sepracor Inc.
LICENSE AGREEMENT FOR LEVOCETIRIZINE
BETWEEN UCB FARCHIM S.A., having its registered office at Z.I de Planchy,
10 chemin de Croix Blanche, C.P. 411, CH-1630 Bulle, Switzerland,
acting in its own name and on behalf of its AFFILIATE (S),
hereinafter "UCB"
on the one hand,
AND SEPRACOR INC., having its registered office at 111 Locke Drive,
Marlborough, MA 01752, USA, hereinafter "SEPRACOR",
on the other hand,
(individually a Party and collectively the Parties)
WITNESSETH:
WHEREAS, SEPRACOR owns patents with respect to Levocetirizine;
WHEREAS, UCB has expertise and resources in manufacturing, marketing,
distribution and management of pharmaceutical products (more particularly in the
field of respiratory diseases) and owns patents in respect of Cetirizine and
Levocetirizine; and
WHEREAS, UCB desires to obtain an exclusive license under SEPRACOR's patents to
manufacture, promote, distribute and sell pharmaceutical products containing
Levocetirizine in the TERRITORY subject to the terms and conditions herein set
forth and SEPRACOR is willing to grant said license.
NOW, THEREFORE, IT HAS BEEN AGREED AS FOLLOWS:
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ARTICLE 1 - DEFINITIONS
1.1 "ACTIVE INGREDIENT" means the pharmaceutical compound (-) Cetirizine, also
known as Levocetirizine, or (-) [2-[4-[(4-Chlorophenyl)phenylmethyl]-1-
piperazinyl]ethoxy]acetic acid, including pharmaceutically acceptable
salts and esters thereof. . For the avoidance of any doubt, the parties
expressly agree that racemic Cetirizine is not included within the
definition of ACTIVE INGREDIENT.
1.2 "AFFILIATE" means with respect to a party (i) any company at least fifty
percent (50%) of whose issued and voting capital is owned or controlled,
directly or indirectly, by said party, or (ii) any company which owns or
controls, directly or indirectly, at least fifty percent (50%) of the
issued and voting capital of said party. A company shall be an AFFILIATE
for such time as the above-described ownership or control exists.
1.3. "CALENDAR QUARTER" " shall mean a three (3) month period ending on March
31, June 30, September 30, and December 31.
1.4. "COMBINATION PRODUCT" means any pharmaceutical specialty containing ACTIVE
INGREDIENT and at least one other active substance.
1.5. "MARKETING YEAR" means each calendar year during the term of this
Agreement, provided that the first MARKETING YEAR shall begin on the first
day of the month during which UCB first invoices PRODUCT in the TERRITORY
and shall end on December 31 of the same year, and the last MARKETING YEAR
shall begin on the last January 1 during the term of this Agreement and
shall end upon its expiration or termination.
1.6. "MARKET SALES" means the sales of PRODUCT invoiced to an independent third
party by UCB or by any of its sublicensees or AFFILIATE (S) in a
particular country of the TERRITORY for all therapeutic indications,
exclusive of that portion of that is prescribed by dermatologists ( the
"dermatologist portion"), unless a SEPRACOR PATENT is granted in such
country covering such dermatological applications. The dermatologist
portion shall be determined on a PRODUCT by PRODUCT basis by an
independent third party selected by mutual agreement of the parties. The
dermatologist portion shall deemed to be
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
equal to the number of units of a PRODUCT that is prescribed by
dermatologists in Belgium, Germany, France, Spain, and Italy, divided by
the total number of units of such PRODUCT prescribed in Belgium, Germany,
France, Spain, and Italy, such numbers to be determined by an analysis of
available relevant prescription audit data for PRODUCT. For the avoidance
of doubt, in the event that sales of PRODUCT are invoiced by UCB to its
AFFILIATE(S) or sublicensee(s) in a particular country of the TERRITORY,
such sales shall not be included in the MARKET SALES; rather, Market Sales
shall include the invoiced sale by the UCB AFFILIATE(S) or sublicensee to
their customers. MARKET SALES in a legal tender which is not the United
States Dollar ("Dollar"), shall be converted into Dollars for the purposes
hereof at the average of the exchange rate of the currency of invoicing
into Dollars, as reported in the Wall Street Journal (Eastern Edition)
during the CALENDAR QUARTER of invoicing of the PRODUCT.
1.7. "MONO-PRODUCT" means any pharmaceutical specialty containing the ACTIVE
INGREDIENT as its sole active substance.
1.8. "NET SALES" means the net value of the MARKET SALES, being the gross
amount minus [**] and [**] for [**] for [**] or [**] included in the [**]
and [**] included in the [**]
1.9. "PATENT COMBINATION PRODUCT" means a COMBINATION PRODUCT covered by one or
more claims of granted SEPRACOR COMBINATION PATENTS.
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1.10. "PRODUCT" means any pharmaceutical specialty containing the ACTIVE
INGREDIENT as an active substance. PRODUCT shall include MONO-PRODUCT and
COMBINATION PRODUCT.
1.11. "SEPRACOR KNOW-HOW" shall mean information which (i) as of the effective
date hereof, is in the possession of SEPRACOR, which it is allowed to
disclose to UCB and which relates specifically to the manufacture, sale,
distribution, registration, use or testing of ACTIVE INGREDIENT or
PRODUCT, or (ii) hereafter, during the term of this Agreement, is
developed solely by SEPRACOR independent of any third party and which
relates specifically to the manufacture, sale, distribution, registration,
use or testing of ACTIVE INGREDIENT or PRODUCT.
1.12. "SEPRACOR PATENT" means the patents and patent applications in the
TERRITORY listed in Schedule1.12 (a) together with the patents and patent
applications in the TERRITORY listed in Schedule 1.12(b), together with
continuations, continuations in part, divisionals and reissues thereof in
the TERRITORY, and any extensions or SPCs of any of the foregoing.
SEPRACOR BASIC PATENTS shall mean the patents and patent applications in
the TERRITORY listed in Schedule 1.12(a) together with any continuations,
continuations in part, divisionals and reissues thereof in the TERRITORY,
and any extensions or SPCs of any of the foregoing. SEPRACOR COMBINATION
PATENTS shall mean the patent application listed in Schedule 1.12(b)
together with any continuations, continuations in part, divisionals and
reissues thereof in the TERRITORY, and any extensions or SPCs of any of
the foregoing.
1.13. "TERRITORY" means the entire world, less the USA and Japan.
ARTICLE 2 - OBJECT OF THE AGREEMENT
2.1 Grant of license
Subject to the terms and conditions of this Agreement, SEPRACOR hereby
grants UCB, and UCB hereby accepts, (i) an exclusive license in the
TERRITORY, including the right to sublicense within the TERRITORY, under
SEPRACOR PATENT(S), to manufacture, have manufactured, promote,
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distribute and sell PRODUCT in the TERRITORY and (ii) a nonexclusive
license in the TERRITORY, including the right to sublicense within the
TERRITORY, under SEPRACOR KNOW-HOW, to manufacture, have manufactured,
promote, distribute and sell PRODUCT in the TERRITORY.
2.2 SEPRACOR KNOW-HOW
Promptly upon execution of this Agreement and throughout the term hereof
SEPRACOR shall disclose to UCB the SEPRACOR KNOW-HOW. At UCB's request,
SEPRACOR shall request in writing from third parties towards which it may
be bound by confidentiality obligations (if any) their consent to the
disclosure, by SEPRACOR to UCB, of SEPRACOR KNOW-HOW.
2.3 Trademark
UCB shall be free to select the trademark for the sale and marketing of
PRODUCT in the TERRITORY; such trademark will be and remain the sole
property of UCB.
2.4 Clinical development, PRODUCT Registration
(a) UCB shall, at UCB's expense, use good faith reasonable efforts to
develop, and obtain marketing authorization for the MONO-PRODUCT in
the TERRITORY.
(b) UCB shall be responsible for conducting all clinical trials with the
ACTIVE INGREDIENT and obtaining for PRODUCT marketing authorization
from the regulatory authorities in those countries of the TERRITORY
in which UCB in its sole discretion shall so elect, the initial list
of which is attached in Schedule 2.4.
2.5 Development Reports
Within one month after the end of each CALENDAR QUARTER, UCB shall provide
SEPRACOR with a quarterly report of the status of the research and
development activities and progress of any application for marketing
authorization, as applicable, in connection with PRODUCT in the TERRITORY.
Further, UCB shall inform SEPRACOR of commencement, completion, and
results of the major phases of clinical development of the
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PRODUCT, including but not limited to Phase II and Phase III clinical
trials, submission of applications for marketing authorization, approval
letters, and launch. It is, however, understood that UCB shall not be
required to disclose confidential parts of the results of the said
clinical development. In case SEPRACOR enters into a license agreement
with a third party to make, use, or sell Product under SEPRACOR PATENTS
for the territory of the United States of America and/or Japan (i)
SEPRACOR shall not be entitled to communicate the confidential content of
the said reports to such licensee (ii) UCB shall be immediately and
automatically released of any obligation under this Section 2.5
2.6 USA and Japan
During the four month period following the execution of this Agreement
SEPRACOR and UCB shall initiate and pursue good faith negotiations on the
terms and conditions under which UCB may be granted a license to make,
use, and sell Product under SEPRACOR's intellectual property relating to
Product in the United States of America and Japan.
If Parties do not reach an agreement within the said four month period,
SEPRACOR shall be free to enter into negotiations with third parties.
ARTICLE 3 - ROYALTIES
3.1 Calculation
(a) In partial consideration for granting the license pursuant to Section
2.1 of this Agreement, UCB shall pay to SEPRACOR a running royalty at the rates
set out in Schedule 3.1 hereto calculated as a percentage of the total NET SALES
of MONO-PRODUCT. Royalties shall be payable on sales of MONO-PRODUCT in each
country of the TERRITORY in which the SEPRACOR BASIC PATENTS have been granted
at the time of such sale. Royalties shall be payable until such time as the
SEPRACOR BASIC PATENT expires in the country in question or is held invalid or
unenforceable in such country in a binding decision from which no appeal has
been taken or from which
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no appeal has been taken in the time allowed for appeal, subject to the
following two sentences. If the SEPRACOR BASIC PATENT is held invalid or
unenforceable in a country of the Territory, and if an independent third party
generic equivalent of MONO-PRODUCT is legally introduced in such country, the
royalty obligation of this Section 3.1(a) shall be suspended as to such
MONO-PRODUCT in such country. If SEPRACOR successfully appeals against the
decision which holds the SEPRACOR BASIC PATENT invalid or unenforceable, UCB
shall upon notification of such appeals decision retroactively pay to SEPRACOR
royalties on the sales during the time period from the suspension of the royalty
obligation until the appeals decision.
(b) In partial consideration for granting the license pursuant to Section
2.1 of this Agreement, UCB shall pay to SEPRACOR a running royalty at the rates
set out in Schedule 3.1 hereto calculated as a percentage of the total NET SALES
of PATENT COMBINATON PRODUCT as follows: Royalties shall be payable on NET SALES
of PATENT COMBINATION PRODUCT in each country of the TERRITORY in which such
claim of the SEPRACOR COMBINATION PATENTS has been granted at the time of such
sale. Royalties shall be payable until such time as the SEPRACOR COMBINATION
PATENT expires in the country in question or is held invalid or unenforceable in
such country in a binding decision from which no appeal has been taken or from
which no appeal has been taken in the time allowed for appeal, subject to the
following two sentences. If a SEPRACOR COMBINATION PATENT covering a PATENT
COMBINATION PRODUCT is held invalid or unenforceable in a country of the
TERRITORY, and if an independent third party generic equivalent of the PATENT
COMBINATION PRODUCT is legally introduced in such country, the royalty
obligation of this Section 3.1(b) shall be suspended as to such product in such
country. If SEPRACOR successfully appeals against the decision which holds the
SEPRACOR COMBINATION PATENTS invalid or unenforceable, UCB shall upon
notification of such appeals decision retroactively pay to SEPRACOR royalties on
the sales during the time period from the suspension of the royalty obligation
until the appeals decision. The full amount of NET SALES of PATENT COMBINATION
PRODUCT shall be subject to the royalty obligation of this Section 3.1(c).
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
(c) As regards COMBINATION PRODUCT containing ACTIVE INGREDIENT and
pseudoephedrine as the sole active substances, the royalty obligation of Section
3.1 (a) shall apply to [**] of the full amount of NET SALES of such PRODUCT.
(d) As regards COMBINATION PRODUCT other than the ones referred to under
points (b) and (c) of this Section 3.1, the royalty obligation of Section 3.1
(a) shall apply, and NET SALES subject to the royalty rate set forth in Schedule
3.1 shall be calculated by multiplying number of grams of ACTIVE INGREDIENT in
the COMBINATION PRODUCT by the weighted average Net Sales price of a gram of
ACTIVE INGREDIENT sold in the form of MONO-PRODUCT in the country of sale;
provided, however, that if MONO-PRODUCT is not available in the country of sale,
the full amount of NET SALES of such COMBINATION PRODUCT shall be subject to the
royalty rate set forth in Schedule 3.1. ".
3.2 Financial Reporting
UCB shall provide a report in writing to SEPRACOR within thirty (30) days
of the end of each CALENDAR QUARTER which will set forth the NET SALES for
the considered CALENDAR QUARTER and the detailed calculation of the
royalties due to SEPRACOR pursuant to Section 3.1 for the same period.
3.3 Terms of payment
At the same time as the report required under Section 3.2 above, UCB shall
pay to SEPRACOR at its address set forth in Section 3.7 below, the full
amount of royalties due as per Section 3.1 here above for the said period.
At the end of each MARKETING YEAR, UCB shall reconcile the amount of
royalty due SEPRACOR against the actual amounts paid for the MARKETING
YEAR concerned. In case of underpayment by UCB, UCB shall promptly pay the
difference; in case of overpayment by UCB, UCB shall be entitled to offset
the difference against the royalties due for the next CALENDAR QUARTER.
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Any such payment shall be made in U.S. Dollars.
3.4 Taxes
All royalties to be paid to SEPRACOR by UCB pursuant to this Agreement
shall be paid after deduction of the withholding taxes lawfully imposed
thereon, which taxes shall be paid by UCB for the account of SEPRACOR;
provided that UCB shall upon request supply SEPRACOR with original or
certified copies of official certificates stating that the aforesaid taxes
have been actually paid for the account of SEPRACOR. The previous sentence
notwithstanding, the parties hereto will reasonably cooperate in
completing and filing documents required under the provisions of any
applicable tax laws or under any other applicable law, in order to enable
UCB to make such payments to SEPRACOR without any deduction or
withholding.
3.5 Records
UCB shall keep and maintain, and shall cause its AFFILIATE(S),
sublicensees and assigns to keep and maintain, complete and accurate
records and books of account in sufficient detail and form so as to enable
royalties to be determined, including but not limited to, true and
accurate records of sales of PRODUCT and calculations of NET SALES and
royalties. SEPRACOR shall have the right to audit the records of UCB at
its own expense using a nationally recognized firm of independent
certified accountants. Such accountants will have access on reasonable
notice to UCB and its AFFILIATE(S) and sublicensees' records during
reasonable business hours for the purpose of verifying the royalties for
the two preceding years. Notwithstanding the foregoing, this right may not
be exercised more than once in any calendar year, and once a calendar year
is audited it may not be reaudited, and said accountant shall disclose to
SEPRACOR only information relating solely to the accuracy of the reports
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
provided to SEPRACOR and the payments made to SEPRACOR under this
Agreement.
Any adjustment required as a result of an audit conducted under this
Article shall be made within twenty-five (25) days after the date on which
the accountant conducting the audit issues a written report to SEPRACOR
and UCB containing the results of the audit. If any underpayment by UCB is
greater than five percent (5%) of the amount previously paid to SEPRACOR
for the relevant quarter, the costs and expenses of the audit shall be
paid for by UCB. In the case of overpayment, UCB may, at its option,
offset royalties and interest (if any) payable to SEPRACOR by the amount
of the overpayment.
3.6 No part of any amount payable to SEPRACOR under this Agreement may be
reduced due to any counterclaim, set-off, adjustment or other right which
UCB might have against SEPRACOR, any other party or otherwise, except as
expressly stated to the contrary in this Agreement.
3.7 All payments to SEPRACOR pursuant to this Agreement shall be made by wire
transfer, to Fleet Bank of Massachusetts, 75 State Street, Boston,
Massachusetts 02109 (ABA #011000138) to Account No. [**] or such other
bank or account as SEPRACOR may from time to time designate in writing.
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ARTICLE 4 - SALES
4.1 Reasonable efforts
UCB shall use reasonable efforts to extend and develop the sales of
MONO-PRODUCT within the TERRITORY and to promote the same to all potential
purchasers thereof, all in a manner consistent with the efforts used by
UCB in connection with other products of similar strategic and financial
significance.
4.2 Launch date
Unless the approved price of PRODUCT, or other market conditions, does not
warrant launch, UCB shall launch PRODUCT within three (3) months from the
date of obtention of marketing authorization and any required government
price and reimbursement approvals in a particular country of the
TERRITORY. However, UCB may extend this three (3) month period after due
consultation with SEPRACOR, up to maximum six (6) months, so as to allow
UCB to launch the PRODUCT shortly before the pollen season in a particular
country of the TERRITORY. For the avoidance of doubt, the parties
expressly agree that possible encroachment of PRODUCT sales into sales by
UCB, its affiliates or licenses, of products containing racemic cetirizine
shall not constitute grounds for delaying launch of PRODUCT pursuant to
this Section 4.2.
ARTICLE 5 - INTELLECTUAL PROPERTY RIGHTS
5.1 Patent protection
SEPRACOR shall be responsible for maintaining and prosecuting at its own
expense the SEPRACOR PATENTS.
5.2 Registration of license
UCB shall be entitled to register the present license at any Patent
Offices if such registration is permissible or needed under the law of the
countries in respect of which the license is granted. SEPRACOR shall give
UCB any powers and authorization necessary for this purpose. The expenses
of such registrations shall be borne by UCB.
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5.3 Infringement of SEPRACOR PATENTS
UCB shall inform SEPRACOR in writing of all cases of infringement of any
of the SEPRACOR PATENTS that come to UCB's attention.
SEPRACOR shall have the right, but not the obligation, to take legal
action against third parties for infringement of any SEPRACOR PATENTS in
the TERRITORY, provided it promptly (but in no event later than four weeks
after it was informed by UCB of the case of infringement) notifies UCB in
writing of its decision to take legal action. If SEPRACOR decides it will
take action, it shall have full control thereover. UCB shall have the
right to consult with SEPRACOR and be represented by its own counsel at
its own expense, and SEPRACOR shall in good faith consider UCB's interests
in the conduct of any such suit. UCB shall have the right, prior to
commencement of an action brought by SEPRACOR, to join such action as a
party; provided, however, that SEPRACOR shall retain control of such
action as set forth above. UCB shall reasonably cooperate with SEPRACOR in
any such action (including but not limited to joining such action as a
party in the event that UCB's absence as a party would adversely affect
the action). In the event that UCB has been joined in the action, no
settlement, consent judgment or other voluntary final disposition of the
action may be entered into without the consent of UCB.
The cost of an action brought by SEPRACOR against an infringer shall be
borne by SEPRACOR. Any amounts recovered shall, after deduction of the
costs of litigation, be apportioned between UCB and SEPRACOR, proportional
to their respective damage; provided however, that any punitive,
exemplary, or other enhanced damages shall be apportioned equally between
the parties.
In case SEPRACOR notifies UCB that it will not take legal action against
the infringer or in case SEPRACOR has not notified UCB of its decision to
take action within the four week period referred to in the first paragraph
of this Section 5.3, UCB shall have the right to undertake the same at its
own cost and
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discretion, and any amounts recovered shall be retained by UCB. Pending
the conduct, by UCB, of such legal action against the infringer and until
UCB has obtained a binding decision from which no appeal has been taken or
from which no appeal has been taken in the time allowed for appeal, UCB
shall be released of the obligation to pay royalties on the NET SALES in
the country or countries in which a third party infringes the SEPRACOR
PATENTS.
5.4 Infringement of third party rights
In the event of institution of an infringement action in the TERRITORY by
a third party against UCB alleging infringement of any intellectual
property rights of such third party in connection with the manufacture,
use, or sale of PRODUCT UCB, UCB shall undertake the defense thereof at
their own expense and discretion.
ARTICLE 6 - REPRESENTATIONS AND WARRANTIES
SEPRACOR warrants and represents that it has all right, title and interest in
the SEPRACOR PATENTS.
SEPRACOR warrants and represents that, to the best of its knowledge, the
SEPRACOR PATENTS that are granted as of the effective date hereof are valid and
enforceable .
SEPRACOR warrants and represents that it has not and will not enter into any
agreement, oral or written, with any third party preventing the use of the
SEPRACOR PATENTS in the TERRITORY by UCB.
UCB warrants and represents that it is not currently a party to, and during the
term of this Agreement will not enter into, any agreements, oral or written,
that are inconsistent with its obligations under this Agreement.
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ARTICLE 7 - CONFIDENTIALITY
7.1 Each party ("Receiving Party") acknowledges that any information supplied
to it by the other party ("Disclosing Party") under this Agreement
relating to the Disclosing Party's and/or the Disclosing Party's
AFFILIATE(S)' business and/or the ACTIVE INGREDIENTS and/or PRODUCT is
confidential and undertakes to keep secret any such confidential
information. The Receiving Party shall not without the Disclosing Party's
prior written consent disclose the confidential information to any third
party nor use the same for any purpose other than the fulfillment of its
obligations under the terms of this Agreement.
7.2 The Receiving Party shall ensure that each of its employees to whom any
such information is disclosed is made aware prior to such disclosure of
the restrictions herein contained and that such employees observe such
restrictions.
7.3 The obligations of Section 7.1 shall have no application when and to the
extent that confidential information: was known to the receiving party
prior to receipt from the disclosing party; was generally available to the
trade or to the public prior to receipt thereof from the disclosing party;
through no act on the part of the receiving party, hereafter becomes
information generally available to the trade or to the public; corresponds
in substance to information received in good faith by the receiving party
from a third party and is not subject to an obligation of confidentiality
owed by the third party to the disclosing party; is hereafter
independently developed by an employee or agent of the receiving party
without reference to information received hereunder; or is required to be
disclosed by law, regulation, or other act of governmental authority,
provided, however, that the receiving party shall give prompt notice to
the disclosing party of any such required disclosure in order to afford
the disclosing party an opportunity to oppose or limit the required
disclosure.
7.4 Nothing in this Article 7 shall prevent UCB or its sublicensees to
exercise their rights granted under or pursuant to this Agreement.
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ARTICLE 8 - TERM AND TERMINATION
8.1 Term
This Agreement shall be effective on the date of last signature hereof and
shall continue for the duration of the SEPRACOR PATENTS.
8.2 Termination by either party
In addition to other termination rights provided in this Agreement, either
Party may terminate this Agreement on written notice to the other party,
effective immediately
(i) if the other Party commits a material breach of any of its obligations
under this Agreement which is not cured within ninety (90) days of written
notice from the other Party specifying the breach. SEPRACOR may effectuate
termination on a country-by-country basis in connection with breach by UCB
arising out of Section 2.4, 4.1, or 4.2.
Such right of termination shall be without prejudice, and in addition to
any other remedy the non-defaulting Party may have at law or in equity due
to the other Party's breach of its obligations hereunder.
(ii) if the other party is dissolved or liquidated, files or has filed
against it a petition under any bankruptcy or insolvency law, makes an
assignment for the benefit of its creditors or has a receiver appointed
for all or substantially all of its property.
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8.3 Termination by SEPRACOR
SEPRACOR shall have the right to terminate this Agreement, effective
immediately, if after the effective date, UCB, its AFFILIATE(S),
sublicensees or assigns, or any third party of which SEPRACOR can
demonstrate it acts on the behalf of UCB, its AFFILIATE(S), sublicensees
or assigns, persists despite a written notice sent by SEPRACOR in any
proceeding or action alleging invalidity or unenforceability of SEPRACOR
PATENT(S) in the TERRITORY, or non-infringement of SEPRACOR PATENT(S) by
any PRODUCT for any use, before any court, administrative or other
government agency, or patent authority in the TERRITORY, or initiates or
participates in any such proceeding or action before any court,
administrative or other government agency, or patent authority in the
TERRITORY.
ARTICLE 9 - EFFECTS OF TERMINATION
9.1 No relief
Expiration or termination of this Agreement in whole or in part shall not
relieve the parties of the obligation to pay any amounts owing between
them, nor shall it relieve the parties of their obligations under Sections
7, 9, 10 and 11, and any other Section providing for its survival, which
shall survive such expiration or termination, in accordance with their
terms.
9.2 Stocks
On termination of this Agreement for any reason whatsoever SEPRACOR shall
grant UCB sufficient time (which period of time shall not exceed twelve
months) to sell its existing stocks of PRODUCT including stock on order at
that time (subject to payment to the applicable royalty obligations of
this Agreement).
ARTICLE 10 - GOVERNING LAW - JURISDICTION
This Agreement shall be ruled and interpreted according to the laws of England.
Any dispute concerning the validity, the interpretation or the performance of
this Agreement shall be finally settled under the Rules of the International
Chamber of Commerce by one or more arbitrator(s) appointed in accordance with
the said Rules.
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The place of arbitration shall be London. The proceedings shall be conducted in
the English language.
ARTICLE 11 - GENERAL PROVISIONS
11.1 Force majeure
The failure of either of the parties hereto to perform any obligation
under this Agreement solely by reason of causes beyond its control,
including but not limited to acts of God, acts of government, riots, wars,
strikes, natural disasters, shall not be deemed to be a breach of this
Agreement; provided, however, that the party so prevented from complying
herewith shall continue to take all reasonable actions within its power to
comply as fully as possible herewith. If such event causes or is
reasonably anticipated to cause delay in performance for more than ninety
(90) days, then either party may terminate this Agreement, effective upon
written notice to the other party.
11.2 Assignment - Subcontracting
This Agreement and each and every covenant, term and condition herein is
binding upon and enures to the benefit of the parties hereto and their
respective successors.
Neither Party may without the prior written approval of the other:
(i) assign this Agreement in whole to any party other than its
respective AFFILIATE(S), provided, however, either party may,
without such approval, assign the Agreement and its rights and
obligations hereunder in connection with the transfer or sale of all
or substantially all of its assets related to the division or the
subject business, or in the event of its merger or consolidation or
change in control or similar transaction, or
(ii) designate or cause any party other than its respective AFFILIATE(S)
or one or more UCB sublicensees to perform all or part of its
activities hereunder or to have the benefit of all or part of its
rights hereunder.
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In the event of subcontracting to an AFFILIATE or assignment, the
respective AFFILIATE or assignee shall be bound by the provisions of this
Agreement.
11.3 Indemnification
UCB agrees to defend SEPRACOR, its successors and assigns, and its
officers, directors, employees, stockholders, agents, AFFILIATE(S) and any
person who controls any of such persons at UCB's cost and expense, and
will indemnify and hold harmless SEPRACOR, its successors and assigns, and
its, officers, directors, employees, stockholders, agents, AFFILIATE(S)
and any person who controls any of such persons (an "Indemnified SEPRACOR
Party") (including reasonable attorneys', consultants' and other
professional fees and disbursements of every kind, nature and description
incurred by such Indemnified SEPRACOR Party in connection therewith)
(collectively, "Damages") that such Indemnified SEPRACOR Party may
sustain, suffer or incur from and against any and all liabilities, claims,
demands, judgments, losses, costs, damages, fees or expenses whatsoever
arising out of or in connection with the manufacture, commercialization,
marketing, sale or use of any PRODUCT, including, but not limited to,
claims by a third party alleging infringement of any intellectual property
rights of such third party in connection with the manufacture, use, or
sale of PRODUCT, and any actual or alleged injury, damage, death or other
consequent occurring to any person as a result, directly or indirectly, of
the possession, use or consumption of any PRODUCT, whether claimed by
reason of breach of warranty, negligence, product defect or otherwise, and
regardless of the form in which any such claim is made.
SEPRACOR shall indemnify and hold harmless UCB its successors and assigns,
and its officers, directors, employees, stockholders, agents, AFFILIATE(S)
and any person who controls any of such persons (an "Indemnified UCB
Party") from and against any liabilities, claims, demands,
<PAGE>
19
judgments, losses, costs, damages or expenses whatsoever (including
reasonable attorneys', consultants' and other professional fees and
disbursements of every kind, nature and description incurred by such
Indemnified UCB Party in connection therewith) (collectively, "Damages")
that such Indemnified UCB Party may sustain, suffer or incur to the extent
that such Damages are attributed to it from any breach of any
representation, warranty, covenant or agreement of SEPRACOR contained in
this Agreement.
See attached Appendix A which is hereby incorporated by reference.
11.4. Publicity
SEPRACOR and UCB shall jointly issue a press release promptly after the
execution hereof concerning this Agreement, which press release shall be
agreed to between the parties prior to issue. A party may not publicize or
disclose the terms or conditions hereof without the prior written consent
of the other party. Nothing in the foregoing, however, shall prohibit a
party from making such disclosures to the extent deemed necessary under
applicable federal or state securities laws or any rule or regulation of
any nationally recognized securities exchange, provided same is accurate
and complete. In such event, however, the disclosing party shall use good
faith efforts to consult with the other party prior to such disclosure
and, where applicable, shall request confidential treatment to the extent
available.
11.5 Headings
Headings are inserted for convenience and shall not affect the meaning or
interpretation of this Agreement or any article thereof.
11.6 Waiver
No waiver of any default hereunder by either party or any failure to
enforce any rights hereunder shall be deemed to constitute a waiver of any
subsequent default with respect to the same or any other provision hereof.
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20
11.7 Severability
Should any part of this Agreement be held unenforceable or in conflict
with the applicable laws or regulations of any jurisdiction, the invalid
or unenforceable part or provision shall be replaced with a provision
which accomplishes, to the extent possible, the original business purpose
of such part or provision in a valid and enforceable manner, and the
remainder of this Agreement shall remain binding upon the parties hereto.
11.8 Notices
All notices given by one party to the other party shall be in writing.
They shall be deemed given the sooner of receipt or three business days
after having been posted.
They shall be addressed to the addresses indicated on the first page of
this Agreement:
if to UCB: UCB FARCHIM S.A.
Attn: General Manager
if to SEPRACOR: SEPRACOR Inc.
Attn: President, Pharmaceuticals
or to the latest address of such party as shall have been communicated in
writing to the other party.
11.9 Entire agreement
This Agreement and the Schedules hereto constitute the whole understanding
between the parties on the subject matter hereof and shall prevail on any
other terms. Any amendment or modification to this Agreement shall only be
made in writing and shall only be valid when signed by both parties.
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21
11.10 Independent Contractor
The activities to be performed by either Party hereunder are undertaken by
it as an independent contractor and not as an agent of the other Party.
Neither Party shall at any time, enter into or incur, or hold itself out
to third parties as having authority to enter into or incur on behalf of
the other Party, any commitments, expenses or liabilities whatsoever. It
is not the intent of the Parties hereto to form any partnership or joint
venture and it is understood and agreed that no such partnership or joint
venture shall be created by this Agreement.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed
by their duly authorized representatives.
Done in two copies, each party having received its copy.
UCB FARCHIM S.A. SEPRACOR Inc.
/s/ Croufer /s/ David S. Barlow
---------------------------- -------------------
Name: Croufer Name: David S. Barlow
Title: Vice President Title: President, Pharmaceuticals
/s/ Marc Wiers
---------------------------- ------------------------
Name: Marc Wiers Name:
Title: President Title:
Place: Atlanta Place: Atlanta
Date: May 27, 1999 Date: May 27, 1999
<PAGE>
22
LIST OF SCHEDULES
to the License Agreement between SEPRACOR Inc. and UCB FARCHIM S.A., signed on
May 27, 1999
<PAGE>
23
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
SCHEDULE 1.12 SEPRACOR PATENTS
<TABLE>
<CAPTION>
Our Ref. No. Country Application No. Filing Date Patent No. Issue Date Subject Status
<S> <C> <C> <C> <C> <C> <C> <C>
[**]
</TABLE>
<PAGE>
24
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
SCHEDULE 2.4 Initial list of countries in which MARKETING AUTHORIZATION will be
sought
[**]
<PAGE>
25
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
SCHEDULE 3.1
To the extent the cumulative applicable NET SALES in a given MARKETING YEAR are
below USD [**]
On the part of applicable NET SALES between USD [**]
On the part of applicable NET SALES between USD [**]
On the part of applicable NET SALES exceeding USD [**].