EXHIBIT 10.49
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DISTRIBUTION AND SUPPLY AGREEMENT
This Agreement is made as of this 18th day of February 2003, by and between
MEDA AB (publ), a company organized under the laws of Sweden, with its principal
offices at Xxx 000 000 X-000 00 Xxxxx, Xxxxxx ("MEDA"), and VIVUS International,
Ltd., a company organized under the laws of Bermuda, with its principal offices
at Xxxxxxxxx Xxxxx, Xxxxxx Xxxxxx, Xxxxxxxx, Xxxxxxx. ("VIVUS").
RECITALS
WHEREAS, VIVUS has developed the medical device, ACTIS(R), an Adjustable
Constriction Loop for the treatment of male erectile dysfunction; and
WHEREAS, MEDA is interested in obtaining distribution rights to ACTIS(R),
and VIVUS is interested in granting such rights to MEDA; and
NOW, THEREFORE, in consideration of the mutual obligations and promises as
set forth herein, the parties do hereby agree as follows:
ARTICLE 1 - DEFINITIONS
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For purposes of this Agreement, the following terms shall have the
following respective meanings:
1.1 Affiliate means any corporation, firm, partnership or other
entity, whether de jure or de facto, that directly or
indirectly owns, is owned by or is under common ownership with
a party to the extent of in excess of fifty percent (50%) of
the outstanding securities or assets having the power to vote
on or direct the affairs of the entity.
1.2 CE Marking means products regulated by the European
Commissions Health, Safety and Environmental Protection
Legislation, which indicates the manufacturer has conformed to
all obligations required by the legislation.
1.3 Confidential Information means any information, data or
business plans relating to the Product or otherwise to the
subject of this Agreement, which a party discloses to the
other party, except any portion thereof which:
(i) is known to the receiving party at the time of
disclosure and documented by written records made
prior to the date of this Agreement;
(ii) is disclosed to the receiving party by a third person
who has a right to make such disclosure;
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(iii) becomes patented, published or otherwise part of the
public domain through no fault of the receiving
party; or
(iv) is independently developed by the receiving party as
evidenced by its written records.
1.4 Effective Date means the date of this Agreement first written
above.
1.5 First Commercial Sale means the first sale of Product (as
defined below) in the Territory by MEDA or any MEDA Affiliate
or sublicensee to any unaffiliated third party.
1.6 Product means the medical device ACTIS(R), an Adjustable
Constriction Loop for the treatment of male erectile
dysfunction.
1.7 Regulatory Approval means all governmental approvals and
authorizations necessary for the commercial marketing and sale
of the Product in the Territory including the CE Marking.
1.8 Supply Price means the price as set forth in Article 3.2
below.
1.9 Territory means Austria, Belgium, Czech Republic, Denmark,
Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland,
Portugal, Spain, Sweden, Switzerland, The Netherlands, Turkey
and the United Kingdom.
1.10 Trademark means the trademark ACTIS.
ARTICLE 2 - GRANT OF RIGHTS
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2.1 Appointment. VIVUS hereby grants to MEDA exclusive
distribution rights (exclusive even as to VIVUS) to use,
market and sell the Product in the Territory. MEDA may
sublicense these rights to any one or more of its Affiliates
at MEDA's sole discretion, and may sublicense third parties
with VIVUS's prior written consent, such consent not to be
unreasonably withheld.
ARTICLE 3 - PURCHASE AND SALE
-----------------------------
3.1 Purchases and Sale of Product. Subject to the terms and
conditions of this Agreement, VIVUS shall exclusively to MEDA,
sell the volumes of the Product required by MEDA for further
sale in the Territory and MEDA shall purchase its requirements
of Product exclusively from VIVUS, at the Supply Price. All
sales of Product to MEDA are final.
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3.2 Supply Price. The Product shall be sold to MEDA at a price of
$[*] in year one and shall be adjusted by a [*] increase each
year thereafter.
3.3 Payments. Any payments due VIVUS or MEDA under this Agreement
shall be made by remitting to the bank account designated by
the party to whom payment is to be made. Any such payments
shall be made in U.S. Dollars.
3.4 Taxes. Where any sum due to be paid to VIVUS hereunder is
subject to any withholding or similar tax, the parties shall
use their best efforts to do all such acts and things and to
sign all such documents as will enable them to take advantage
of any applicable double taxation agreement or treaty. In the
event there is no applicable double taxation agreement or
treaty, or if an applicable double taxation agreement or
treaty reduces but does not eliminate such withholding or
similar tax, MEDA shall pay such withholding or similar tax to
the appropriate government authority, deduct the amount paid
from the amount due VIVUS and secure and send to VIVUS the
best available evidence of such payment.
ARTICLE 4 - FORECASTS, ORDERS, INVOICES AND TITLE
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4.1 Initial Forecast. Within thirty (30) days of the Effective
Date, MEDA shall provide to VIVUS its then current best
forecast of the quantity of Product that MEDA will require
from VIVUS, by month for the next two calendar quarters.
4.2 Rolling Forecasts. No later than ninety (90) days prior to the
first day of each calendar quarter after the initial calendar
quarter, MEDA shall provide to VIVUS its then current best
forecast of the quantity of Product that MEDA will require
from VIVUS during each of the next four (4) calendar quarters.
MEDA shall break down the forecast for the first two such
calendar quarters of the forecast by month.
4.3 Order and Acceptance. Firm binding orders must be made at
least two (2) months in advance of delivery date, and VIVUS is
obliged to confirm these orders within seven (7) days of
receipt. If MEDA does not receive such notice, the order is
deemed to have been accepted. MEDA shall not increase or
decrease its forecast, for the second calendar quarter in each
of MEDA's rolling forecasts made pursuant to Article 4.2
above, by more than twenty percent (20%). VIVUS shall accept
all firm orders from MEDA for quantities of Product up to and
including one hundred twenty percent (120%) of the quantity of
Product previously forecasted by MEDA for such calendar
quarter, and shall use its best efforts to accept all firm
orders from MEDA for quantities of Product in excess of that
quantity of Product. Once an order has been accepted by VIVUS,
then VIVUS shall be obligated to sell, and MEDA shall be
obligated to purchase, the ordered Product.
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4.4 Invoices. VIVUS shall invoice MEDA for the Supply Price in
United States Dollars for the Product shipped on the day of
shipment. MEDA shall pay VIVUS such invoiced amount within
thirty (30) days from the date of the receipt of the Product.
4.5 Delivery. VIVUS shall deliver the Product via sea freight to
MEDA,CIF, MEDA's designated warehouses in the respective
countries in the Territory. All shipping costs, liability,
ownership and logistics of Product up to MEDA's designated
warehouses discharging dock, are the responsibility of VIVUS.
In the event MEDA requests delivery of Product via air
freight, then all such shipping costs shall be the
responsibility of MEDA.
4.6 Conflicting Terms and Conditions. Except as otherwise provided
in this Agreement, the terms and conditions of this Agreement
shall govern, notwithstanding any additional or inconsistent
terms or conditions in MEDA's form of purchase order or
similar document or in VIVUS's acknowledgment, invoice, or
similar documents.
4.7 Initial Start-up and At Risk Costs. MEDA will be responsible
for reimbursing VIVUS for VIVUS' actual costs incurred and
expenses paid to third parties to modify the packaging for the
Product in order to incorporate MEDA trade dress (including,
but not limited to, artwork changes, typesetting charges and
plate charges), to otherwise modify the packaging for the
Product to meet MEDA's requirements (including, but not
limited to, packaging materials). MEDA shall not repackage or
re-label Product supplied to MEDA by VIVUS hereunder without
the prior written consent of VIVUS.
ARTICLE 5 - SAMPLING, TESTING AND ANALYSIS
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5.1 Defective Product. MEDA shall notify VIVUS in writing of any
claim relating to damaged or defective Product or any shortage
in quantity of any shipment of the Product within thirty (30)
days of receipt of such Product or, if the defect is not
readily apparent based upon a reasonable inspection (a "Hidden
Defect"), within thirty (30) days after which the Hidden
Defect becomes known to MEDA. A Hidden Defect is defined as a
defect that existed at the time Product is delivered and, for
avoidance of doubt, a Hidden Defect does not include any
defect that might be caused in the storage or transportation
of the Product. If MEDA fails to give such written claim
notice to VIVUS within said thirty (30) day period, the
Product shipped shall be deemed to be sufficient in quantity
and not damaged nor defective at the time of delivery. If MEDA
gives such written claim notice to VIVUS within said thirty
(30) day period, then MEDA and VIVUS shall, in an appropriate
manner to be agreed, jointly inspect the Product to see if
claimed damage or defect actually exists in the Product
shipped. If existence of claimed damage, defect or shortage is
reasonably verified through such inspection, VIVUS shall
replace the rejected Product or make up the shortage as soon
as practicable but no later than ninety (90) days after such
verification, at no extra cost to MEDA, and shall make
arrangements with MEDA for the destruction of any rejected
Product, at VIVUS's expense.
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ARTICLE 6 - DEVELOPMENT AND REGULATORY ISSUES
---------------------------------------------
6.1 VIVUS Responsibilities. VIVUS shall be responsible for, and
shall bear all costs of the following:
a. VIVUS shall provide to MEDA, as expeditiously as
possible, appropriate assistance, information and/or
materials in VIVUS's possession or control in order
to enable or facilitate MEDA's filing for a CE
Marking to market and sell the Product in the
Territory.
b. VIVUS shall be responsible for filing trademark
applications for, and for the maintenance and upkeep
of, the Trademark in the Territory.
c. VIVUS shall provide Product to MEDA in final
packaging for distribution in the Territory
6.2 MEDA Responsibilities. During the term of this Agreement,
MEDA shall be responsible for, and shall bear all cost of, the
following:
a. MEDA shall, at its own expense, be responsible for
(i) Preparing, filing and maintaining a CE
Marking and/or other Marketing or Regulatory
Authorizations necessary for distribution of
the Product in the Territory; and
(ii) Providing VIVUS with camera-ready artwork
for the final packaging of Product including
MEDA's trade dress.
x. XXXX shall own all registrations and Regulatory
Approvals for the Product in the Territory.
c. In fulfilling its obligations under this Agreement,
MEDA shall use its reasonable best efforts to ensure
that the Product is entitled to and receives the
maximum available benefit of any regulatory market
exclusivity periods or other safeguards or extensions
of proprietary status, which are or may be applicable
in the Territory.
6.3 Pharmacovigilance. MEDA will have overall responsibility for
Pharmacovigilance in the Territory. Promptly after the
Effective Date and prior to Product distribution by MEDA, the
respective pharmacovigilance groups of VIVUS and MEDA shall
enter into a separate agreement covering adverse event
information exchange relating to the Product. Such agreement
will permit the inclusion of the respective pharmacovigilance
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groups of other third parties to whom VIVUS has granted or
will grant (during the term of this Agreement) similar rights
to make, have made, use and sell the Product outside the
Territory.
6.4 Regulatory Communications. MEDA and VIVUS shall promptly
inform each other of any material communications to or from
governmental authorities or agencies relating to the Product
that affect marketing and/or sale of Product in the Territory.
With the exception of product recalls, which are to be handled
pursuant to Article 8 below, and adverse event reporting,
which is to be handled pursuant to Article 6.3 above, the
parties shall consult with each other regarding any issues
raised in such communications, and shall attempt in good faith
to agree upon any action to be taken or response to be made in
connection with such communications. If the parties are unable
to agree within a reasonable time prior to when the action is
to be taken or the response is to be made, the party receiving
the material communication for the Product shall decide what
action to take or response to make.
ARTICLE 7 - MARKETING AND SALES
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7.1 MEDA Diligence. MEDA shall use its diligent efforts to market
and/or sell the Product in the Territory, consistent with the
efforts that MEDA expends on pursuing commercialization of
other products MEDA markets in the Territory of similar market
potential. MEDA agrees that neither MEDA nor its Affiliates or
Authorized Distributors will market or distribute any medical
device products for the treatment of Erectile Dysfunction in
the Territory other than the Product.
ARTICLE 8 - PRODUCT RECALL
--------------------------
8.1 Recall in the Territory. In the event that in the Territory
(i) any government authority issues a request, directive or
order that the Product be recalled, or (ii) a court of
competent jurisdiction orders such a recall, or (iii) MEDA and
VIVUS jointly determine that the Product should be recalled,
MEDA shall take all appropriate corrective actions. If such
recall results from any cause or event attributable solely to
VIVUS's negligence or fault, VIVUS shall be responsible for
the direct expenses of the recall. If such recall results from
any cause or event attributable solely to MEDA's negligence or
fault, MEDA shall be responsible for the direct expenses of
the recall. If such recall results from any other cause or
event (including attribution to the negligence or fault of
both VIVUS and MEDA), the parties shall share equally the
direct expenses of the recall. For the purposes of this
Agreement, the direct expenses of recall shall include,
without limitation, the expenses of notification and return of
the recalled Product and MEDA's costs for the Product, and
shall not include the cost of any re-launch by MEDA of the
Product in the Territory subsequent to a recall.
8.2 Recall Outside the Territory. In the event that outside the
Territory (i) any government authority issues a request,
directive or order that the Product be recalled, or (ii) a
court of competent jurisdiction orders such a recall, or (iii)
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VIVUS (or its Affiliates or sublicensees, as the case may be)
decides that the Product should be recalled, VIVUS shall
notify MEDA as expeditiously as possible and shall provide
MEDA with all information and assistance as MEDA may
reasonably request in order to enable MEDA to determine any
appropriate actions relating to the Product in the Territory
arising from such recall.
ARTICLE 9 - REPRESENTATIONS AND WARRANTIES
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Each party hereby represents and warrants for itself as follows:
9.1 Organized. It is a corporation duly organized, validly
existing and is in good standing under the laws of the
jurisdiction of its incorporation, is qualified to do business
and is in good standing as a foreign corporation in each
jurisdiction in which the conduct of its business or the
ownership of its properties requires such qualification and
failure to have such would prevent it from performing its
obligations under this Agreement and has all requisite
corporate power and authority to conduct its business as now
being conducted, to own, lease and operate its properties and
to execute, deliver and perform this Agreement.
9.2 Due Execution. The execution, delivery and performance by it
of this Agreement have been duly authorized by all necessary
corporate action and do not and will not (i) require any
consent or approval of its stockholders; (ii) violate any
provision of any law, rule, regulation, order, writ, judgment,
injunction, decree, determination or award presently in effect
having applicability to it or any provision of its charter or
by-laws; or (iii) result in a breach of or constitute a
default under any material agreement, mortgage, lease, license
(including any license from a third party which is necessary
for the full performance of this Agreement), permit or other
instrument or obligation to which it is a party or by which it
or its properties may be bound or affected.
9.3 No Third Party Approval. No authorization, consent, approval,
license, exemption of, or filing or registration with, any
court or governmental authority or regulatory body (other than
health regulatory authorities) is required for the due
execution, delivery or performance by it of this Agreement,
except as provided herein.
9.4 Binding Agreement. This Agreement is a legal, valid and
binding obligation of such party, enforceable against it in
accordance with its terms and conditions. It is not under any
obligation to any person, contractual or otherwise, that is in
conflict with the terms of this Agreement.
9.5 Full Disclosure. Each Party has disclosed to the other in good
faith all material information relevant to the subject matter
of this Agreement and to such party's ability to observe and
perform its obligations hereunder.
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ARTICLE 10 - COVENANTS, REPRESENTATIONS AND WARRANTIES OF VIVUS
---------------------------------------------------------------
VIVUS covenants, represents and warrants to MEDA that:
10.1 VIVUS Rights. VIVUS has the right to grant the rights granted
in this Agreement and no provision in any third party
agreement to which VIVUS is a party will prevent VIVUS from
performing its obligations under this Agreement.
10.2 Specifications. All quantities of the Product will comply
with, and VIVUS shall only release Product for shipment to
MEDA which comply with (i) all specifications of the Product
in the Regulatory Approvals granted by the regulatory
authorities in the Territory; (ii) all Specifications; and
(iii) all applicable legal and regulatory requirements
relating to the manufacture of the Product for sale in the
Territory, including but not limited to Good Manufacturing
Practices.
10.3 Current Good Manufacturing Practices ("cGMP")/Regulatory
Requirements. All manufacturing and quality control methods
utilized by VIVUS and/or VIVUS's third-party contract
manufacturer(s) in the manufacture of the Product shall be
carried out in accordance with all applicable rules governing
medical devices in the Good Manufacturing Practice for medical
devices and regulations issued by the health regulatory
authorities in the Territory for which such Product is to be
sold as in effect at the time and the applicable standards in
effect at the time (collectively, the "Manufacturing
Standards").
10.4 Documentation. VIVUS shall keep and maintain, for a minimum of
five (5) years after the date of distribution, (i) reference
samples and quality control records for each batch of starting
materials and packaging material used in the manufacture of
the Product, and (ii) manufacturing and quality control
records for each batch of the Product. Each shipment of the
Product shall be accompanied by the following written
documentation:
a. the date of final packaging;
b. delivered amount of Product units; and
c. a certificate of compliance pursuant to Article 6.
10.5 Product Liability Insurance. The Parties shall maintain
product liability insurance consistent with their normal
business practices from time to time to cover risks related to
the Product and, upon either Party's request, to provide the
other Party with certificates of insurance attesting to the
existence of such insurance.
10.6 Coverage. During the Term and for a period of two (2) years
thereafter, each Party shall obtain and maintain insurance
coverage from a reputable arm's-length insurer in respect of
its respective obligations under Article 10.5 and in respect
of third-person liability in an amount of not less than
[*] . Each Party shall
add the other Party as a co-insured under its respective
insurance policy
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ARTICLE 11 - FORCE MAJEURE
--------------------------
11.1 Upon occurrence of an event of force majeure, the party
affected shall promptly notify the other party in writing,
setting forth the details of the occurrence, its expected
duration and how that party's performance of its obligations
under this Agreement is affected. The affected party shall
resume the performance of its obligations as soon as
practicable after the force majeure event ceases. If a party's
performance of any obligation under this Agreement is
significantly hindered or is prevented by an event of force
majeure for more than six (6) months, whether or not
consecutive, in any twelve (12) month period, then the other
party may terminate this Agreement upon thirty (30) days'
notice.
ARTICLE 12 - ALLOCATION OF SUPPLY
---------------------------------
12.1 Allocation of Supply. In the event of VIVUS's inability to
supply the Product ordered by MEDA, VIVUS shall allocate its
available supply between MEDA, VIVUS and VIVUS's licensee(s)
outside the Territory on a fair and equitable basis based on a
pro-rata share of worldwide Product sales for the six (6)
months preceding and the forecasted worldwide Product sales
for the next six (6) months following such allocation. SUCH
ALLOCATION SHALL BE MEDA'S SOLE REMEDY FOR VIVUS'S FAILURE TO
SUPPLY MEDA QUANTITIES OF PRODUCT VIVUS IS OTHERWISE OBLIGATED
TO SUPPLY UNDER ARTICLE 4 OF THIS AGREEMENT.
ARTICLE 13 - TRADEMARKS
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13.1 Trademark Rights. VIVUS hereby grants to MEDA the exclusive
right, exclusive even as to VIVUS, to use the Trademarks in
connection with the Product in the Territory during the term
of this Agreement. MEDA acknowledges that such Trademarks
shall be and are the sole property of VIVUS.
13.2 Electronic Address. VIVUS hereby grants to MEDA a
non-exclusive right to use VIVUS's registered electronic
address, xxx.xxxxx.xxx, for the purpose of linking electronic
users with MEDA's relevant web pages, web sites or other
electronic addresses relating to the Product in the Territory.
MEDA hereby grants to VIVUS a non-exclusive right to use
MEDA's registered electronic address, xxx.xxxx.xx for the
purpose of linking electronic users with VIVUS's relevant web
pages, web sites or other electronic addresses relating to the
Product.
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ARTICLE 14 - INFRINGEMENT
-------------------------
14.1 Third Party Infringement. Each party will notify the other
party if it becomes aware of the activities of any third party
that are believed to infringe the Trademark. The parties shall
consult as to potential strategies against the alleged
infringer, including but not limited to litigation strategy.
14.2 Litigation.
a. If the efforts of the parties are not successful in
abating the alleged infringement, then VIVUS shall
have the right, but not the obligation, to bring an
appropriate suit or action against such infringement,
at its own expense. MEDA agrees to cooperate in any
such infringement action and agrees to execute all
papers and perform such other acts as may be
reasonably requested by VIVUS at MEDA's expense.
VIVUS shall consult with MEDA and take into account
MEDA's recommendations regarding the conduct of such
action, provided that VIVUS shall have full right and
authority to determine the strategy and tactics for
such action and to settle, consent to judgment, or
otherwise resolve any such action or suit. The
provisions of the foregoing notwithstanding, no such
resolution shall be binding on MEDA without its prior
written consent (which consent shall not be
unreasonably withheld) unless such resolution does
not (i) impose any liability, loss, cost or
obligation upon MEDA, and (ii) adversely affect
MEDA's rights under this Agreement.
b. If VIVUS does not elect to bring suit against the
alleged infringer, MEDA shall have the right, but not
the obligation, to bring an appropriate suit or
action against such infringer in the Territory, at
MEDA's own expense. VIVUS agrees to cooperate in any
such infringement action and agrees to execute all
papers and perform such other acts as may be
reasonably requested by MEDA (including but not
limited to consent to be joined as a nominal party
plaintiff in such action), at VIVUS's expense. MEDA
shall consult with VIVUS and take into account
VIVUS's recommendations regarding the conduct of such
action, provided that MEDA shall have full right and
authority to determine the strategy and tactics for
such action and to settle, consent to judgment, or
otherwise resolve any such action or suit. The
provisions of the foregoing notwithstanding, no such
resolution shall be binding on VIVUS without its
prior written consent (which consent shall not be
unreasonably withheld) unless such resolution does
not (i) impose any liability, loss, cost or
obligation upon VIVUS and (ii) adversely affect
VIVUS's rights under this Agreement.
c. If VIVUS or MEDA brings an infringement action
pursuant to this Article 14, any amount recovered in
any action or suit against a third party infringer
shall be allocated as follows: first, to the party
bringing such action in order to reimburse such party
for the costs and expenses of such action; second,
with respect to any remaining amount, [*]
of that portion of such amount resulting from
infringement within the Territory to MEDA, and the
rest of any remaining amount to VIVUS.
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ARTICLE 15 - TERM AND TERMINATION
---------------------------------
15.1 Term. The term of this Agreement shall commence on the
Effective Date and shall, unless earlier terminated pursuant
to this Article 15 or other express termination provisions in
this Agreement, expire on the tenth (10th) anniversary of the
First Commercial Sale of Product.
15.2 Breach. Either party may, in addition to any other remedies
available to it by law or in equity, terminate this Agreement
upon sixty (60) days' written notice in the event that the
other party commits a material breach of this Agreement and
fails to cure such breach within sixty (60) days of notice of
the breach. The party giving notice of breach may withhold any
payments otherwise due and owing to the breaching party, to be
used as a setoff against any loss or damage arising from the
breach, and said withholding shall not constitute breach of
this Agreement. Any amounts so withheld shall be deposited by
the withholding party into an interest-bearing escrow account.
If the breaching party cures the breach within the sixty (60)
day cure period and this Agreement is not terminated, then the
withholding party shall promptly pay to the other party the
withheld amount, less that portion of such amount which was
applied as a setoff. Notwithstanding the foregoing provision,
if MEDA gives notice of breach to VIVUS, MEDA may withhold
other payments pursuant to this Article 15.2 but shall not be
entitled to withhold payment for Product actually ordered by
and delivered to MEDA pursuant to Article 4 of this Agreement.
15.3 Insolvency or Bankruptcy. Either party may, in addition to any
other remedies available to it by law or in equity, terminate
this Agreement, upon thirty (30) days' written notice to the
other party in the event the other party shall have become
insolvent or bankrupt, or shall have made an assignment for
the benefit of its creditors, or there shall have been
appointed a trustee or receiver of the other party or for all
or a substantial part of its property, or any case or
proceeding shall have been commenced or other action taken by
or against the other party in bankruptcy or seeking
reorganization, liquidation, dissolution, winding-up,
arrangement, composition or readjustment of its debts or any
relief under any bankruptcy, insolvency, reorganization or
other similar act or law of any jurisdiction now or
hereinafter in effect.
15.4 Serious Events. Should there occur serious and unexpected
events which, from a reasonable pharmaceutical company's point
of view, would make it impossible or impracticable to pursue
the commercialization of the Product, including but not
limited to a serious adverse event associated with the
Product, either party may, with full consultation with the
other party, terminate this Agreement upon thirty (30) days'
written notice. Termination by a party in good faith pursuant
to this Article 15.4 shall not, in itself, constitute a basis
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for any claim for compensation or other remedies by the other
party. In the event of termination by VIVUS under this Article
15.4, VIVUS shall be restricted from commercializing the
Product, either directly or indirectly, for a period of two
(2) years in the Territory.
15.5 Change of Control or Ownership. Either party may terminate
this Agreement upon thirty (30) days' written notice if the
ownership or control of at least fifty percent (50%) of the
assets or voting securities of the other party are transferred
and, in the non-changing party's reasonable judgment, the
other party's new owner or controlling entity is a competitor
of the non-changing party in the field of erectile dysfunction
in the Territory.
15.6 Survival of Liability. Except as expressly provided otherwise
in this Agreement, termination, expiration, cancellation or
abandonment of this Agreement through any means and for any
reason shall not relieve the parties of any obligation
accruing prior thereto and shall be without prejudice to the
rights and remedies of either party with respect to any
antecedent breach of any provision of this Agreement.
15.7 Remaining Inventory. MEDA shall maintain a normal level of
inventory of the Product prior to expiration or termination of
this Agreement, and shall have a period of six (6) months from
the date of termination of this Agreement during which it may
sell its remaining inventory of Product, provided it sell such
inventory in a manner substantially similar to the manner in
which it was selling Product prior to the termination.
15.8 Survival. Upon expiration or termination of this Agreement,
all rights and obligations of the parties under this Agreement
shall terminate except those rights and obligations described
in ARTICLES 1, 8.1, 10.4, 15, 16, 17 AND 18.
ARTICLE 16 - INDEMNITY
----------------------
16.1 By VIVUS. In addition to indemnification expressly provided
elsewhere in this Agreement, VIVUS shall indemnify, defend and
hold MEDA, its directors, employees, agents and
representatives (including but not limited to MEDA's
Affiliates) harmless from and against all claims, causes of
action, settlement costs (including but not limited to
reasonable attorney's fees and expenses) losses or liabilities
of any kind which:
(a) arise from or are attributable to any negligent act
or omission or willful misconduct on the part of
VIVUS or its Affiliates, or its or their directors,
employees, agents or representatives relating to any
of VIVUS' obligations under this Agreement, including
but not limited to any breach of a representation or
warranty;
(b) arise from or are attributable to the manufacture of
the Product and which in either case are not
otherwise attributable to any negligent act or
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omission or willful misconduct on the part of MEDA,
its directors, employees, agents or representatives
(including, but not limited to, MEDA's Affiliates);
16.2 By MEDA. In addition to indemnification expressly provided
elsewhere in this Agreement, MEDA shall indemnify, defend and
hold VIVUS, its directors, employees, agents and
representatives harmless from and against all claims, causes
of action, settlement costs (including but not limited to
reasonable attorney's fees and expenses) losses or liabilities
of any kind which:
(a) arise from or are attributable to any negligent act
or omission or willful misconduct on the part of
MEDA, its directors, employees, agents or
representatives relating to any of its obligations
under this Agreement; or
(b) arise from or are attributable to the storage, use,
sale, marketing and promotion of the Product by MEDA
in the Territory and which in either case are not
otherwise attributable the manufacture of a Product
and which in either case are not otherwise
attributable to any negligent act or omission or
willful misconduct on the part of VIVUS, its
directors, employees, agents or representatives.
16.3 Condition of Indemnification. If either party expects to seek
indemnification under this Section, it shall promptly give
notice pursuant to Section 18.5 below to the indemnifying
party of the basis for such claim of indemnification. If
indemnification is sought as a result of any third party claim
or suit, such notice to the indemnifying party shall be within
fifteen (15) days after receipt by the other party of such
claim or suit; provided, however, that the failure to give
notice within such time period shall not relieve the
indemnifying party of its obligation to indemnify unless it
shall be materially prejudiced by the failure. The
indemnifying party shall have full control over the defense of
such claim or suit; provided that the indemnified party shall
have the right to participate, at its own expense, with
counsel of its own choosing, in such defense. The indemnified
party shall fully cooperate with the indemnifying party in the
defense of all such claims or suits. The indemnifying party
shall make no offer of settlement, settlement or compromise
without the prior written consent of the indemnified party
(which consent shall not be unreasonably withheld) unless such
settlement fully releases the indemnified party without any
liability, loss, cost or obligation.
16.4 Term of Indemnification. The obligations of the parties set
forth in this Article 16 shall apply during the term of this
Agreement and for a period of five (5) years after the date of
termination in whole or expiration of this Agreement or any
extension thereof.
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ARTICLE 17 - CONFIDENTIALITY AND DISCLOSURE
-------------------------------------------
17.1 Confidentiality. Neither party shall use or disclose any
Confidential Information received by it pursuant to this
Agreement without the prior written consent of the other. This
obligation shall continue for a period of seven (7) years
after expiration or termination of this Agreement.
17.2 Disclosure. Nothing contained in this Article 17 shall be
construed to restrict the parties from disclosing Confidential
Information as required: (i) for regulatory, tax, securities
or customs reasons, (ii) by court or other government order,
(iii) for confidential audit purposes; or (iv) from using such
Confidential Information as is reasonably necessary to perform
acts permitted by this Agreement, including the registration,
marketing, sale or use of the Product.
ARTICLE 18 - MISCELLANEOUS
--------------------------
18.1 Assignment. This Agreement may not be assigned or otherwise
transferred, nor, except as expressly provided hereunder, may
any right or obligation hereunder be assigned or transferred
by either party without the prior written consent of the other
party; provided, however, that either VIVUS or MEDA may,
without such consent, assign this Agreement and its rights and
obligations hereunder in connection with the transfer or sale
of all or substantially all of its assets, its merger or
consolidation or any similar transaction, and that MEDA may,
without such consent, assign this Agreement and its rights and
obligations hereunder to one or more of its Affiliates. Any
permitted assignee shall assume all obligations of its
assignor under this Agreement.
18.2 Sublicensees. In the event that MEDA grants sublicenses under
Article 2, MEDA shall ensure that such sublicensees abide by
all the obligations of MEDA contained in this Agreement to the
extent that such obligations are relevant to and applicable to
such sublicensees.
18.3 Damages. Notwithstanding any provision in this Agreement to
the contrary, in no event shall a party hereto be liable to
the other party for any indirect or consequential damages,
including but not limited to loss of profits or business
opportunity.
18.4 Severability. Each party intends not to violate any public
policy, statutory or common law, rule, regulation, treaty or
decision of any government agency or executive body thereof of
any country or community or association of countries. If any
term or provision of this Agreement is held to be invalid,
illegal or unenforceable by a court or other governmental
authority of competent jurisdiction, such invalidity,
illegality or unenforceability shall not affect any other term
or provision of this Agreement, which shall remain in full
force and effect. The holding of a term or provision to be
invalid, illegal or unenforceable in a jurisdiction shall not
have any effect on the application of the term or provision in
any other jurisdiction.
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18.5 Notices. Any consent or notice required or permitted to be
given or made under this Agreement by one party to the other
shall be in writing, delivered personally or by facsimile (and
promptly confirmed by personal delivery, first-class mail or
courier), first-class mail or courier, postage prepaid (where
applicable), addressed to the other party as shown below or to
such other address as the addressee shall have last furnished
in writing to the addresser and (except as otherwise provided
in this Agreement) shall be effective upon receipt by the
addressee.
If to VIVUS: VIVUS International Limited
c/o VIVUS, Inc.
0000 Xxxxxx Xxxxxx
Xxxxxxxx Xxxx, XX 00000
Attention: Legal Department
Fax: (000) 000-0000
If to MEDA: MEDA AB
Pipers vag 2
Xxx 000, XX-000 00 Xxxxx,
Xxxxxxxxx: CEO
Fax: x00 0 000 00 00
18.6 Applicable Law. This Agreement shall be governed by and
construed in accordance with the laws of the State of
California, excluding its conflict of laws provision.
Application of the United Nations Convention On Contracts For
The International Sale Of Goods is hereby excluded.
18.7 Entire Agreement. This Agreement contains the entire
understanding of the parties with respect to the subject
matter hereof. All express or implied agreements and
understandings, either oral or written, heretofore made are
superseded by this Agreement. Except as expressly provided
elsewhere in this Agreement, this Agreement may be amended, or
any term hereof modified, only by a written instrument duly
executed by both parties hereto.
18.8 Headings. The captions to the Articles hereof are not a part
of this Agreement, but are merely guides or labels to assist
in locating and reading the Articles hereof.
18.9 Independent Contractors. It is expressly understood and agreed
that VIVUS and MEDA are independent contractors and that the
relationship between the two parties shall not constitute a
partnership, joint venture or agency. Neither VIVUS nor MEDA
shall have the authority to make any statement,
representations or commitments of any kind, or to take any
action, which shall be binding on the other, without the prior
written consent of the party to do so.
15
18.10 Waiver. The waiver by either party of any right hereunder or
of a failure to perform or breach by the other party shall not
be deemed a waiver of any other right hereunder or of any
other failure or breach whether of a similar nature or
otherwise.
18.11 Dispute Resolution. Prior to either party initiating any court
proceedings against the other party, the parties shall first
attempt to resolve any disputes arising out of or related to
this Agreement as follows. Either party may initiate the
dispute resolution process by delivering written notice to the
other party setting forth the matter in dispute. Such matter
shall be referred to a joint committee comprised of at least
one (1) member nominated by each party. The joint committee
shall meet within ten (10) business days of receipt of such
notice. The joint committee shall have a period of ten (10)
business days to attempt to resolve the matter in dispute. If
the joint committee is unable to resolve the dispute by
unanimous resolution within such time, the joint committee
will escalate the dispute to the chief executive officers of
the parties for resolution. If the respective chief executive
officers cannot resolve the dispute within fifteen (15)
business days after the date such dispute was escalated, then
either party may refer such dispute for resolution by court
proceedings
18.12 Counterparts. This Agreement may be executed in two or more
counterparts, each of which shall be deemed an original, but
all of which together shall constitute one and the same
instrument.
THEREFORE, the parties hereto have executed this Agreement as of the first
day above written.
MEDA AB VIVUS INTERNATIONAL, LTD.
By: /s/ Xxxxxx Xxxxxx By: /s/ Xxxxxx Xxxxxx
------------------------ ------------------------
Title: CEO Title: President and CEO
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Date: 2/18/03 Date: 2/21/03
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