EXHIBIT 10.53
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MANUFACTURE AND SUPPLY AGREEMENT
This Manufacturing and Supply Agreement ("Agreement") is entered into
as of December 22, 2003 ("Effective Date") by and between VIVUS, Inc., having a
principal place of business at ▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇
▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇▇ of America ("VIVUS"), and NeraPharm spol., s.r.o., having a
place of business at ▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ("NeraPharm").
WHEREAS, NeraPharm is a worldwide licensed manufacturer of prostaglandin;
WHEREAS, VIVUS desires to acquire a certain prostaglandin produced by
NeraPharm.
NOW, THEREFORE, in consideration of the mutual promises and covenants
herein contained, the parties hereto agree as follows:
ARTICLE 1 - DEFINITIONS
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1.1 DMF" shall mean a drug master file, or its equivalent for the Product
filed with a regulatory agency by or on behalf of NeraPharm which is
adequate to comply with the applicable requirements and standards of
such regulatory agency with respect to the Product.
1.2 "PH Eur" shall mean European Pharmacopoeia.
1.3 "FDA" shall mean the United States Food and Drug Administration.
1.4 "GMP" shall mean good manufacturing practices as defined by the FDA in
21 CFR Part 211 and European Guidelines.
1.5 "MUSE/ ALISTA System" shall mean VIVUS' system for delivery of the
Product to treat male and female sexual dysfunction, as modified from
time to time during the term of this Agreement.
1.6 "Product" shall mean Alprostadil USP (Prostaglandin E1)/Ph Eur
(Prostaglandin E1).
1.7 "Specifications" shall mean the particulars as to composition, quality
and other characteristics for the Product as set forth in Exhibit A
hereto, as may be amended from time to time by mutual agreement of the
parties.
1.8 "USP" shall mean United States Pharmacopoeia.
ARTICLE 2 - SUPPLY
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2.1 Supply. NeraPharm shall supply to VIVUS quantities of the Product in
full manufacturing lots ordered by VIVUS from time to time in
accordance with this Agreement. Without limiting the foregoing,
NeraPharm shall at all times maintain facilities to manufacture, with
three (3) months prior notice, at least (*) (* - *) of Product per
quarter. The (*) and (*) quantity is the expected yield of the
manufactured lot that NeraPharm will validate for the production of
Product to be supplied by NeraPharm to VIVUS under this Agreement.
NeraPharm will use only validated lot sizes and processes for
production of Product for supply to VIVUS. VIVUS and NeraPharm must
mutually agree to any other batch size NeraPharm may wish to validate
and use for Product supply under this Agreement.
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2.2 Orders. Quantities of the Product will be supplied by NeraPharm
pursuant to purchase orders submitted by VIVUS from time to time.
NeraPharm agrees to accept VIVUS' purchase orders for the Product,
provided that the purchase order is in accordance with the forecast
provided and other stipulations of this Agreement and provides for a
lead time of not less than six (6) weeks, but not to exceed ten (10)
weeks. NeraPharm's obligation to supply within this lead time period
shall be limited to those quantities included in the forecast provided
by VIVUS at least six (6) months earlier.
2.3 Obligation to Supply. Subject to the terms of this Article 2, NeraPharm
shall accept and fill all orders placed by VIVUS for the product. Per
Section 2.1 of this Agreement, the yield of the manufactured lot size
that NeraPharm will validate for Product supply to VIVUS under this
Agreement is expected to be (*) to (*). Forecasts provided by VIVUS to
NeraPharm for Product supply will be in whole lot quantities with a
target yield of (*) per lot. Beginning in 2005, VIVUS will provide to
NeraPharm a binding six (6) month forecast and a non-binding twelve
(12) month forecast starting from the end of the binding six (6) month
period. The non-binding twelve (12) month forecast will assist
NeraPharm in planning and capacity allocation and the binding six (6)
month forecast will set forth quantities that VIVUS will be obligated
to buy and NeraPharm will be obligated to supply; provided that due to
manufacturing batch yield variances, NeraPharm shall supply quantities
in amounts that are plus or minus (*) of the VIVUS ordered quantity in
(*), and further provided that VIVUS may order an additional (*) per
quarter above the binding forecast amount and up to (*) per four (4)
quarter period. Such binding and non-binding forecasts shall be updated
by VIVUS on February 28, May 30, August 30 and November 30 for eighteen
(18) month periods starting from the first day of the first subsequent
calendar quarter. The total of the quantities indicated for the first
three months of such updated binding forecasts including the firm
orders already placed, but not including back orders, if any, shall be
not less than (*) per quarter less than the quantities indicated for
the same calendar period in the binding forecast issued three (3)
months before. VIVUS, from time to time, may need to purchase
quantities in excess of (*) per quarter above the binding forecast or
more than (*) per four (4) quarter period. In such case, NeraPharm will
use its best efforts to supply VIVUS' requirements.
2.4 Form of Orders. VIVUS' orders shall be made pursuant to a written
purchase order which is in a form mutually acceptable to the parties,
and shall provide for shipment in accordance with reasonable delivery
schedules as may be agreed upon from time to time by NeraPharm and
VIVUS. NeraPharm shall use all reasonable efforts to notify VIVUS
within five (5) days from receipt of an order of its ability to fill
any amounts of such order in excess of the quantities that NeraPharm is
obligated to supply. No terms contained in any purchase order, order
acknowledgment or similar standardized form shall be construed to amend
or modify the terms of this Agreement and in the event of any conflict,
this Agreement shall control unless expressly agreed in writing.
2.5 Minimum Quantities. VIVUS agrees to order at least (*) batches (*) of
Product for delivery during the calendar years 2004, 2005 and 2006.
2.6 Maximum Quantities. Notwithstanding anything herein to the contrary,
NeraPharm shall not be obligated to supply to VIVUS more than (*)
batches of Product in any calendar year provided that NeraPharm agrees
to use all reasonable efforts to supply any quantities in excess of
such amounts as VIVUS may order in accordance with Section 2.3 above.
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2.7 Price. The price to be paid by VIVUS per (*) of the Product ordered by
VIVUS shall be based upon the quantities of the Product ordered by
VIVUS and delivered by NeraPharm during a particular calendar year, as
follows:
2.7.1 The price of Product delivered for the first (*) during the
calendar years 2004, 2005 and 2006 shall be $ (**) per (*).
2.7.2 The Price of Product delivered in excess of (*) kg shall be
mutually agreed by the parties hereto.
2.8 Packaging. Product shall be supplied to VIVUS: (a) in airtight and
moisture-proof containers which have stability to support storage; (b)
in standard quantities of (*), and no less than (*) and no more than
(*); (c) in plastic packing material sufficient to prevent breakage of
bottles while in transport; and (d) with a packaging label(s)
displaying, in addition to the standard requirements, the tare weight,
packaging job number, and bottle serial number per packaging job. The
tare weight indicated shall contain the weight of the empty bottle, cap
and cap insert, but neither of the label weights or that of external
protective materials. A copy of a certificate of analysis for each such
lot shall accompany such lot. A second copy of such certificate of
analysis shall be separately sent to VIVUS.
2.9 Shipping Terms; Payment. All prices set forth in Section 2.7 above
shall be CIP (Incoterms 2000) to an airport (in the case of shipment by
airfreight) or to an address (in the case of shipment by courier
service). The manner of shipment shall be designated by NeraPharm and
the airport or address shall be designated by VIVUS. All payments
hereunder shall be made in U.S. dollars, by direct bank transfer to an
account designated in NeraPharm's Invoice. Payment terms shall be
forty-five (45) days from the date of Invoice.
2.10 Taxes. VIVUS shall be responsible for the payment of any taxes, tariffs
or duties in excess of those covered by NeraPharm pursuant to CIP
(Incoterms 2000) related to the import of the Product into the country
of destination.
ARTICLE 3 - QUALITY
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3.1 Quality. All Product supplied by NeraPharm shall meet (i) the current
USP and European Pharmacopoeia requirements for the Product, (ii) the
current VIVUS Specifications (Exhibit A), (iii) additional requirements
that the parties may agree to from time to time to reflect to the
manufacturing requirements of VIVUS' MUSE/ALISTA System, and (iv) the
requirements of any health regulatory agency to which VIVUS has
submitted, or notifies NeraPharm it will submit or sponsor the
submission of, an application for regulatory approval. In case any
official monograph or regulatory agency requirement conflicts with the
current USP and European Pharmacopoeia requirements for the Product and
NeraPharm's manufacturing and control process of Product described in
the DMF, the parties will consult to seek a mutually acceptable
solution. All Product supplied by NeraPharm shall be manufactured in
accordance with current GMP manufacturing and ISO 9000 regulatory
requirements and record keeping procedures at NeraPharm's plant located
at 27711 Neartovice, Czech Republic (the "Facility").
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3.2 NeraPharm will manufacture (*) batches of Product, approximately (*)
each, in a campaign starting in 2004. The first batch will be completed
no later than March 31, 2004. The second and third batches will follow
thereafter and will be completed no later than June 30, 2004. During
this campaign, NeraPharm will apply change of manufacturing process
validation to assure NeraPharm's current manufacturing process is in
full compliance with current U.S. FDA and European regulatory cGMPs and
with NeraPharm's U.S. and European DMFs.
3.3 NeraPharm agrees to carry out all tests and studies necessary to prove
the equivalence of Product manufactured with NeraPharm's current
manufacturing process using these three batches, including stability
studies, and submit any necessary Specification or DMF changes and all
related results as required by the regulatory authorities in a schedule
set forth below:
a. To the U.S. FDA with three (3) month stability results no later
than October 15, 2004;
b. To the European and other regulatory authorities no later than
thirty (30) days after receipt of a written request from VIVUS,
such written request to occur no earlier than September 15, 2004,
such submission to include the latest stability results available
at the time of submission.
3.4 NeraPharm agrees to provide VIVUS with a detailed analytical report on
its findings on these batches of Product at the time of their
qualification and results of its stability studies at the time such
results are available.
3.5 VIVUS agrees to carry out all tests and studies necessary to acquire
the approval of the U.S., EU and other regulatory authorities for its
use of Product manufactured with the current process of NeraPharm as
active ingredient in its finished product MUSE.
3.6 VIVUS agrees that these tests and studies shall include manufacture and
stability studies of validation batches of MUSE using each of the first
(*) batches of Product from NeraPharm.
3.7 VIVUS agrees to inform NeraPharm about its main findings on these
validation batches of MUSE as well as to notify NeraPharm in a timely
manner regarding regulatory submissions and their outcome.
3.8 Quality Control. Prior to each shipment of Product, NeraPharm shall
perform quality control procedures to verify that the quantity or batch
of such Product to be shipped conforms fully with the Specifications.
Each shipment of Product shall be accompanied by a Certificate of
Analysis describing all current requirements of the Specifications,
results of test performed, as well as Batch Release Sheet certifying
that the batch of Product supplied has been manufactured, controlled
and released according to the Specifications, current DMFs and all
relevant and current GMP requirements at the Facility stipulated under
Section 3.1 above.
3.9 Rejection. VIVUS shall have sixty (60) days following its receipt of a
shipment of Product to reject such Product on the grounds that all or
part of the shipment fails to conform to the applicable Specifications
or otherwise fails to conform to the warranties given by NeraPharm in
Section 5.1, which rejection shall be accomplished by giving written
notice to NeraPharm specifying the manner in which all or part of such
shipment fails to meet the foregoing requirements. If rejection is
based on grounds of contamination or Product not passing any physical
test of Specification, VIVUS' rejection notice shall be accompanied by
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satisfactory sample returned to NeraPharm to verify such
non-conformity. If VIVUS rejects a shipment before the date on which
payment therefore is due, it may withhold payment for such shipment or
the rejected portion thereof. The warranties given by NeraPharm in
Article 5 below shall survive any failure to reject by VIVUS under
Section 3.9.
3.10 Returns and Settlement of Claims. NeraPharm shall be obliged to respond
in writing to VIVUS accepting or refusing a rejection notice from VIVUS
within forty-five (45) days from the date of receipt of such rejection
notice in accordance with Section 3.9 above. In case of disagreement
between the parties, the claim shall be submitted for tests and
decision to an independent testing organization which meets appropriate
GMP or consultant of recognized repute within the United States
pharmaceutical industry mutually agreed upon by the parties (the
"Laboratory"), the appointment of which shall not be unreasonably
withheld or delayed by either party. The determination of such entity
with respect to all or part of any shipment of Product shall be final
and binding upon the parties. The fees and expenses of the Laboratory
making such determination shall be paid by the party against which the
determination is made (i.e., the party whose argument is rejected by
the Laboratory). Products accepted by NeraPharm as not meeting the
applicable requirements and Specifications or so decided by the
Laboratory shall be returned by VIVUS to NeraPharm. NeraPharm shall use
its best efforts to replace the quantities of Product returned by VIVUS
within the shortest possible time, but no later than sixty (60) days
from the return of such quantities. The replacement of returned Product
shall have priority over the supply of Product ordered for shipment,
not more than thirty (30) days before or any time after the return of
the rejected quantity to NeraPharm. Without limiting the remedies of
VIVUS, if NeraPharm fails to replace returned Product within
one-hundred and fifty (150) days from the date Product is returned to
NeraPharm, VIVUS shall have the right (i) to cancel such replacement
shipment by written notice and (ii) to reclaim immediately (either
through refund or setoff, at VIVUS' discretion) the amounts paid
pursuant to Section 2.7 above for the Product that was returned but not
replaced, if such payment for such Product had already been made to
NeraPharm.
3.11 Presence At Facility. Upon reasonable notice given by VIVUS to
NeraPharm and at reasonable frequency, VIVUS shall have the right to
assign a reasonable number of employees or consultants of VIVUS to
inspect and audit the Facility at which Product is manufactured in
order to verify NeraPharm's compliance with the current GMP and other
agreed requirements, provided, however that (a) such employees or
consultants shall not unreasonably interfere with order activities
being carried out of Facility, and (b) that such employees or
consultants shall observe all rules and regulations applicable to
visitors and to individuals employed at the Facility.
ARTICLE 4 - REGULATORY MATTERS
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4.1 Regulatory Approvals.
4.1.1 Requirements. VIVUS and its marketing partners shall notify
NeraPharm in a timely fashion about their requirements for the
submission and maintenance of DMFs related to the manufacture
and control of the Product adequate to comply with applicable
regulatory agencies' (including without limitation the FDA's)
standards with respect to the Product in the United States,
Europe, Canada, and other countries as is or becomes necessary
for VIVUS and its marketing partners to import, export and
sell the MUSE/ALISTA System worldwide. NeraPharm will submit,
at NeraPharm's expense, a DMF or its equivalent in any other
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country imposing requirements fully identical to that of the
United States, Canada or the European Union within two (2)
months after such requirement received from VIVUS or its
marketing partners. In case VIVUS or its marketing partner
requires the submission of a DMF in a country not covered by
the foregoing stipulations, VIVUS will assist NeraPharm,
directly or through others, to obtain the full details of
requirements of a DMF on the manufacture and control of the
Product in the country concerned. NeraPharm will use its best
efforts to fulfill these requirements and to submit such
document with content and form required in the country in
question and at the time required by VIVUS. NeraPharm shall
keep VIVUS and its marketing partners, as appropriate,
informed about its ability or inability to submit and maintain
such documentation as well as the intended or possible times
of such submissions.
4.1.2 DMF Submission. NeraPharm shall submit, at NeraPharm's
expense, DMFs in every country in English or a translation in
English. An English copy of the open part of each DMF, where
such open part exists, shall be provided to VIVUS in parallel
with the submission thereof to the applicable regulatory
agency. NeraPharm agrees to maintain all information filed
with the regulatory agencies current and reflective of current
manufacturing practices and product specifications and to
update this information as required. From time to time during
the term of this Agreement, NeraPharm shall provide letters of
authorization, instruments and/ or documents, and take such
other actions, as VIVUS may reasonably request for purposes of
obtaining regulatory approvals necessary for VIVUS and its
marketing partners to import, export and sell Product as
incorporated into the MUSE/ALISTA System. NeraPharm agrees to
notify VIVUS in a timely fashion of any significant changes,
deletions or modifications to any DMF or Product process or
specification, and not to implement any such changes that
would cause a delay in obtaining regulatory approvals to
market products incorporating the Product without prior
written agreement with VIVUS.
4.2 Inspections. NeraPharm shall permit regulatory agencies to conduct such
inspections of the Facility as the regulatory agencies may request, and
shall cooperate with the regulatory agencies with respect to such
inspections and any related matters. NeraPharm shall give VIVUS prior
written notice of any inspections, and shall keep VIVUS informed about
the results and conclusions of each regulatory inspection, including
actions taken by NeraPharm to remedy conditions cited in such
inspections. In addition, NeraPharm shall allow VIVUS or its
representative to assist in the preparation for and be present at such
inspections. NeraPharm shall provide VIVUS with copies of any written
inspection reports issued by such agencies and all correspondence
between NeraPharm and the agency involved, including, but not limited
to, FDA Form 483 and all correspondence relating thereto. VIVUS and its
regulatory consultants, agents, marketing partners or other third
parties agreed upon in advance by NeraPharm, under reasonable
confidentiality requirements, shall have access, to quality assurance
and current GMP audits of DMFs for the purposes of assessment of
regulatory compliance, to the buildings, records and areas of the
Facility involved in the manufacture, testing, storage and shipment of
the Product.
4.3 VIVUS Cooperation. VIVUS agrees to keep NeraPharm reasonably informed
as to the status of the development and applications for regulatory
approvals of the MUSE/ALISTA System incorporating the Product supplied
hereunder.
4.4 Maintenance of Approvals. Notwithstanding anything herein to the
contrary, NeraPharm shall not undertake any modifications to Product
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manufacturing or testing processes, specifications or filing that could
impact VIVUS product approvals, regulatory product reviews, IND or any
other compliance status without prior written agreement of VIVUS.
NeraPharm shall obtain and maintain all licenses, permits and
registrations necessary to manufacture the Product and supply it
hereunder.
ARTICLE 5 - PRODUCT WARRANTIES
5.1 Process and Product Warranties. NeraPharm warrants and represents that:
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5.1.1 Specifications. All Product supplied to VIVUS hereunder shall
comply with the Specifications for the Product and shall
conform with the information shown on the Certificate of
Analysis and Batch Release Sheet provided for the particular
shipment according to Section 3.2 hereof;
5.1.2 GMP. The Facility, and all Product supplied to VIVUS hereunder
meets (a) all United States and European regulatory
requirements for commercialization of the Product, including
without limitation maintenance of a current DMF, compliance
with GMP, demonstration of commercial production capability,
and demonstration of acceptable stability of such Product; (b)
all ISO 9000 regulatory requirements applicable to the
Product: and (c) all requirements imposed by other regulatory
agencies with which a DMF has been filed for the Product;
5.1.3 USP/Ph Eur. All Product supplied to VIVUS hereunder shall meet
all USP and European Pharmacopoeia and other applicable
standards and shall be fit for human use;
5.1.4 Compliance with FFDCA. None of the Product supplied to VIVUS
hereunder shall be adulterated or misbranded within the
meaning of the Federal Food, Drug and Cosmetics Act, 21
U.S.C.A. ss.301 et seq., as amended and in effect of the time
of shipment (the "Act"), or within the meaning of any state or
municipal laws applicable to the Products and containing terms
with substantially similar meanings as the meanings of
adulteration or misbranding under the Act; provided, however,
that this provision shall not apply to, and NeraPharm shall
have no responsibility for, misbranding caused directly by
VIVUS as a result of labels or package text specified by VIVUS
for the Product;
5.1.5 Timing. All Product supplied to VIVUS hereunder shall have
been manufactured within twenty-two (22) weeks prior to
receipt by VIVUS;
5.1.6 Notification. NeraPharm will provide written notice to VIVUS
of any proposed alterations to the Facility or to any Product
manufacturing or testing process; provided, however, that
under no circumstances shall any such alteration be made
without VIVUS' express prior written consent, or before
regulatory approval, if required for any suchalteration, is
received in each country in which Product is then being sold;
and
5.1.7 No Encumbrance. Title to all Product supplied to VIVUS
hereunder shall pass to VIVUS as provided herein free and
clear of any security interest, lien, or other encumbrance.
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5.2 Disclaimer. EXCEPT AS EXPRESSLY PROVIDED IN THIS ARTICLE 5, NERAPHARM
MAKES NO REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, AS TO THE
PRODUCT, AND NERAPHARM HEREBY EXPRESSLY DISCLAIMS ANY AND ALL IMPLIED
OR STATUTORY WARRANTIES, INCLUDING WITHOUT LIMITATION, WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NONINFRINGEMENT.
ARTICLE 6 - TERM AND TERMINATION
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6.1 Term. The term of this Agreement shall commence on the Effective Date
and continue in full force until December 31, 2006, unless terminated
earlier in accordance with this Article 6.
6.2 Termination for Convenience. Either party hereto may terminate this
Agreement upon ninety (90) days prior written notice to the other party
hereto; provided, however, such termination shall not become effective
prior to December 31, 2004.
6.3 Termination by NeraPharm. NeraPharm shall have the right to terminate
this Agreement on thirty (30) days prior written notice to VIVUS after
the beginning of any calendar year during the term of this Agreement
but before February 28, of such year, if VIVUS fails to order for
delivery the minimum purchase obligation set forth in Section 2.5
during the previous calendar year; provided that VIVUS does not order
sufficient quantities to cure such shortfall within the foregoing
thirty (30)-day period.
6.4 Breach. This Agreement may be terminated by either party if the other
party breaches any material term or condition of this Agreement and
fails to remedy the breach within sixty (60) days after being given
written notice thereof.
6.5 Effect of Termination. In the case of notice termination by either
party under Section 6.3.or 6.4., the parties' obligations, including
NeraPharm's obligation to supply Product ordered by VIVUS, and VIVUS'
obligation to purchase Product included in any binding forecast
pursuant to Section 2.3. shall survive. In addition, VIVUS may purchase
and NeraPharm agrees to supply quantities of Product for which VIVUS
has not found alternate suppliers, at NeraPharm's then current prices
of Product.
6.6 Survival. It is understood that termination or expiration of this
Agreement shall not relieve a party from any liability which, at the
time of such termination or expiration, has already accrued to the
other party. The provisions of Sections 3.9, 3.10, 6.5, 6.6 and 10.1,
and Articles 1, 5, 7, 9, and 11 shall survive the termination of this
Agreement for any reason. All other rights and obligations of the
parties shall cease upon termination of this Agreement. Except as
otherwise expressly provided in this Article 6, all other rights and
obligations of the parties shall terminate.
ARTICLE 7 - CONFIDENTIALITY
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7.1 Confidential Information. The parties may from time to time disclose to
each other Confidential Information. "Confidential Information" shall
mean any information disclosed by one party to the other party hereto
which if disclosed in tangible form is marked "confidential" or with
other similar designation to indicate its confidential or proprietary
nature or if disclosed orally is indicated orally to be confidential or
proprietary by the party disclosing such information at the time of
such disclosure and is confirmed in writing as confidential or
proprietary by the disclosing party within forty-five (45) days after
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such disclosure. Notwithstanding the foregoing, Confidential
Information shall not include any information that, in each case as
demonstrated by written documentation: (i) was already known to the
receiving party, other than under an obligation of confidentiality, at
the time of disclosure, as can be shown by competent proof; (ii) was
generally available to the public or otherwise part of the public
domain at the time of its disclosure to the receiving party; (iii)
became generally available to the public or otherwise part of the
public domain after its disclosure and other than through any act or
omission of the receiving party in breach of this Agreement; (iv) was
subsequently lawfully disclosed to the receiving party by a person
other than the disclosing party, as can be shown by competent proof;
(v) was developed by the receiving party without reference to any
Confidential Information of the disclosing party.
7.2 Confidentiality. Each party hereby agrees: (i) to hold and maintain in
strict confidence all Confidential Information of the other party; and
(ii) not to use or disclose any Confidential Information of the other
party except to those employees and consultants who have a need to
know, as otherwise permitted by this Agreement, or as may be necessary
to exercise its rights or perform its obligations under this Agreement;
provided that each party to whom Confidential Information is disclosed
is bound by the same terms regarding the disclosure and use of
Confidential Information as set forth in this Article 7. Nothing
contained in this Article 7 shall prevent either party from disclosing
any Confidential Information of the other party to (a) regulatory
agencies for the purpose of obtaining approval to distribute and market
the Product; provided, however, that all reasonable steps are taken to
maintain the confidentiality of such Confidential Information to be
disclosed; (b) to accountants, lawyers or other professional advisors
or in connection with a merger, acquisition or securities offering,
subject in each case to the recipient entering into an agreement to
protect such Confidential Information from disclosure; or (c) is
required by law or regulation to be disclosed; provided, however, that
the party subject to such disclosure requirement has provided written
notice to the other party promptly upon receiving notice of such
requirement in order to enable the other party to seek a protective
order or otherwise prevent disclosure of such Confidential Information.
7.3 Return of Confidential Information. Upon termination or expiration of
this Agreement, each party shall return all Confidential Information in
its possession that was received from the other party; provided,
however, that the recipient may retain one copy of such Confidential
Information for its legal files solely for the purpose of monitoring
compliance with applicable confidentiality obligations pursuant to this
Agreement.
ARTICLE 8 - REPRESENTATIONS AND WARRANTIES
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8.1 NeraPharm. NeraPharm represents and warrants that: (i) it has full
power to enter into this Agreement and to grant and assign to VIVUS the
rights granted and assigned to VIVUS hereunder; (ii) it has obtained
all necessary corporate approvals to enter into and execute the
Agreement; (iii) it has not entered and will not enter into any
agreements with any third party that are inconsistent with this
agreement; (iv) NeraPharm shall fully comply with the requirements of
any and all applicable federal, state, local and foreign laws,
regulations, rules and orders of any governmental body having
jurisdiction over the activities contemplated by this Agreement; and
(v) that the provisions of this Agreement, and the rights and
obligations of the parties hereunder, are enforceable under the laws of
the Czech Republic.
8.2 VIVUS. VIVUS represents and warrants that: (i) it has full power to
enter into the Agreement; (ii) it has obtained all necessary corporate
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approvals to enter into and execute this Agreement; (iii) it has not
entered and will not enter into any agreements of any third party that
are inconsistent with this Agreement; and (iv) VIVUS shall fully comply
with the requirements of any and all applicable federal, state, local
and foreign laws, regulations, rules and orders of any governmental
body having jurisdiction over the activities contemplated by this
Agreement.
8.3 Disclaimer. EXCEPT AS PROVIDED IN THIS ARTICLE 8 AND ARTICLE 5 ABOVE,
NEITHER PARTY MAKES ANY WARRANTIES OR CONDITIONS (EXPRESS, IMPLIED,
STATUTORY OR OTHERWISE) WITH RESPECT TO THE SUBJECT MATTER HEREOF.
ARTICLE 9 - INDEMNIFICATION
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9.1 VIVUS. VIVUS shall indemnify, defend and hold harmless NeraPharm, its
directors, officers, employees, agents, successors and assigns from and
against any liabilities, expenses or costs (including reasonable
attorneys' fees) arising out of any claim, complaint, suit, proceeding
or cause of action against any of them by a third party alleging
physical injury or death or otherwise resulting from (i) the clinical
testing of the Product by or on behalf of VIVUS; (ii) the safety of the
Product distributed by or on behalf VIVUS; (iii) the promotion,
distribution, sale, handling, possession, or use of the Product by or
on behalf of VIVUS following its or their acceptance thereof in
accordance with Section 3.3 above; (iv) the negligent or intentionally
wrongful acts or omissions of VIVUS; and (v) any breach by VIVUS of its
representations and warranties under Section 8.2 above, in each case
subject to the requirements set forth in Section 9.3 below.
Notwithstanding the foregoing, VIVUS shall have no obligations under
this Article 9 for any liabilities, expenses or costs arising out of or
relating to claims covered under Section 9.2 below.
9.2 NeraPharm. NeraPharm shall indemnify, defend and hold harmless VIVUS,
its directors, officers, employees, agents, successors and assigns from
and against all liabilities, expenses, and costs (including reasonable
attorneys' fees) arising out of any claim, complaint, suit, proceeding
or cause of action against any of them by a third party alleging
physical injury or death or otherwise resulting from (i) the negligent
or intentionally wrongful acts or omissions of NeraPharm; (ii) any loss
of Product for which NeraPharm bears the risk under Section 2.9; and
(iii) any breach by NeraPharm of any of its representations and
warranties under Section 5.1 or 8.1, in each case subject to the
requirements set forth in Section 9.3 below.
9.3 Indemnification Procedure. Any party seeking indemnification under this
Article 9 (the "Indemnitee") shall (i) promptly notify the indemnifying
party (the "Indemnitor") of such claim, (ii) provide the Indemnitor
sole control over the defense and/ or settlement thereof, and (iii) at
the Indemnitor's request and expense, provide full information and
reasonable assistance to Indemnitor with respect to such claims.
Without limiting the foregoing, with respect to claims brought under
Section 9.1 or 9.2 above, the Indemnitee, at its own expense, shall
have the right to participate with counsel of its own choosing in the
defense and/ or settlement of any such claim.
ARTICLE 10 - INTERNATIONAL ISSUES
---------------------------------
10.1 Language. This Agreement is in English language only, which language
shall be controlling in all respects, and all versions hereof in any
other language shall not be binding on the parties hereto. All
communications and notices to be made or given pursuant to this
Agreement shall be in the English language.
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10.2 Government Approvals. NeraPharm shall:
10.2.1 at its own expense, comply with all applicable laws, and
obtain all approvals and make and maintain in force all
filings, registrations, reports, licenses, permits and
authorizations required by national and local governments
within the Czech Republic in order for NeraPharm to perform
its obligations under this Agreement; and
10.2.2 advise VIVUS of any legislation, rule, regulation or other law
(including but not limited to any customs, tax, trade,
intellectual property or tariff law) which is in effect or
which may come into effect in the Czech Republic after the
Effective Date of this Agreement and which affects the
transfer of Product to VIVUS under this Agreement, or which
has a material effect on any provision of this Agreement.
ARTICLE 11 - GENERAL
--------------------
11.1 Assignment. The parties agree that their rights and obligations under
this Agreement may not be assigned or otherwise transferred to a third
party without the prior written consent of the other party hereto.
Notwithstanding the foregoing, either party may transfer or assign its
rights and obligations under this Agreement to a successor to all or
substantially all of its business or assets relating to this Agreement
whether by sale, merger, operation of law or otherwise; provided that
such assignee or transferee has agreed to be bound by the terms and
conditions of this Agreement. Subject to the foregoing, this Agreement
shall be binding upon and inure to the benefit of the parties hereto,
their successors and assigns.
11.2 Governing Law. This Agreement shall be governed by, and construed and
interpreted in accordance with, the laws of the United Kingdom without
reference to conflict of laws principles and excluding the 1980 U. N.
Convention on Contracts for the International Sale of Goods.
11.3 Arbitration. Any dispute or claim arising out of or in connection with
this Agreement or the performance, breach or termination thereof, shall
be finally settled by binding arbitration in London, England under the
Rules of Arbitration of the International Chamber of Commerce by three
(3) arbitrators appointed in accordance with said rules. The decision
and/ or award rendered by the arbitrators shall be written, final and
non-appealable and may be entered in any court of competent
jurisdiction. The parties agree that, any provision of applicable law
notwithstanding, they will not request, and the arbitrator shall have
no authority to award, punitive or exemplary damages against any party.
The costs of any arbitration, including administrative fees and fees of
the arbitrators, shall be shared equally by the parties, unless
otherwise determined by the arbitrators. Each party shall bear the cost
of its own attorneys' and expert fees. The arbitral proceedings and all
pleadings and written evidence shall be in the English language. Any
written evidence originally in a language other than English shall be
submitted in English translation accompanied by the original or true
copy thereof. Notwithstanding the foregoing, either party may apply to
any court of competent jurisdiction for injunctive relief without
breach of this arbitration provision.
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11.4 Notices. Any notice or report required or permitted to be given or made
under this Agreement by either party shall be in writing and delivered
to the other party at its address indicated below (or to such other
address as a party may specify by notice hereunder by courier or by
registered or certified airmail, postage prepaid, or by facsimile;
provided, however, that all facsimile notices shall be promptly
confirmed, in writing, by registered or certified airmail, postage
prepaid. All notices shall be effective as of the date received by the
addressee.
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If to VIVUS: VIVUS, Inc.
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇
Attn: C. E. O. and C. F. O.
With a copy to: Wilson, Sonsini, ▇▇▇▇▇▇▇▇ & ▇▇▇▇▇▇
▇▇▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇▇
▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇
Attn:
If to NeraPharm: NeraPharm, spol. s.r.o.
▇▇. ▇▇▇▇▇ ▇▇▇
▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇▇▇
▇▇▇▇▇ ▇▇▇▇▇▇▇▇
Attn:
11.5 Limitation of Liability. NEITHER PARTY SHALL BE LIABLE TO THE OTHER
PARTY OR ANY THIRD PARTY FOR ANY SPECIAL, CONSEQUENTIAL, EXEMPLARY OR
INCIDENTAL DAMAGES (INCLUDING LOST OR ANTICIPATED REVENUES OR PROFITS
RELATING TO THE SAME), ARISING FROM ANY CLAIM RELATING TO THIS
AGREEMENT, WHETHER SUCH CLAIM IS BASED ON CONTRACT, TORT (INCLUDING
NEGLIGENCE) OR OTHERWISE, EVEN IF AN AUTHORIZED REPRESENTATIVE OF SUCH
PARTY IS ADVISED OF THE POSSIBILITY OR LIKELIHOOD OF SAME. THESE
LIMITATIONS SHALL APPLY NOTWITHSTANDING THE FAILURE OF THE ESSENTIAL
PURPOSE OF ANY LIMITED REMEDY, AND THE PARTIES ACKNOWLEDGE THAT THIS
PARAGRAPH REPRESENTS A REASONABLE ALLOCATION OF RISK.
11.6 Force Majeure. Neither party will be liable for its failure to perform
any of its obligations hereunder during any period in which such
performance is delayed by acts of God, fire, war, embargo, riots,
strikes or other similar cause outside the control of such party.
11.7 Confidential Terms. Except as expressly provided herein, each party
agrees not to disclose any terms of this Agreement to any third party
without the consent of the other party, except as required by
securities or other applicable laws, to prospective investors and to
such party's accountants, attorneys and other professional advisors.
11.8 Headings. Headings included herein are for convenience only, do not
form a part of this Agreement and shall not be used in any way to
construe or interpret this Agreement.
11.9 Non-Waiver. Any waiver of the terms and conditions hereof must be
explicitly in writing. The waiver by either of the parties of any
breach of any provision hereof by the other shall not be construed to
be a waiver of any succeeding breach of such provision or a waiver of
the provision itself.
11.10 Severability. Should any section, or portion thereof, of this Agreement
be held invalid by reason of any law, statute or regulation existing
now or in the future in any jurisdiction by any court of competent
authority or by a legally enforceable directive of any governmental
body, such section or portion thereof shall be validly reformed so as
to approximate the intent of the parties as nearly as possible and, if
unreformable, shall be deemed divisible and deleted with respect to
such jurisdiction, but the Agreement shall not otherwise be affected.
13
11.11 Independent Contractors. The relationship of VIVUS and NeraPharm
established by this Agreement is that of independent contractors.
Nothing in this Agreement shall be construed to create any other
relationship between VIVUS and NeraPharm. Neither party shall have any
right, power or authority to assume, create or incur any expense,
liability or obligation, express or implied, on behalf of the other.
11.12 Trademarks. VIVUS, in its sole discretion, shall select the trademarks,
trade names and trade dresses to be used in connection with the Product
and all such trademarks, trade names and trade dresses shall be and
become the exclusive property of VIVUS. NeraPharm shall use said
trademarks, trade names and trade dresses for the sole purpose of
manufacturing the Product for supply to VIVUS and at no time shall
adopt any trademark, trade name or trade dress that may be confusingly
similar therewith. NeraPharm shall acquire no rights in and to any
trademarks, trade names and trade dresses selected by VIVUS under this
Section 11.12.
11.13 Entire Agreement. The terms and provisions contained in the Agreement,
including the Exhibits hereto, constitute the entire agreement between
the parties and shall supersede all previous communications,
representations, agreements or understandings, either oral or written,
between the parties with respect to the subject matter thereof.
Notwithstanding the foregoing, neither party waives any rights it may
have under the Supply Agreement. No agreement or understanding varying
or extending this Agreement shall be binding upon either party hereto,
unless set forth in a writing which specifically refers to the
Agreement signed by duly authorized officers or representatives of the
respective parties, and the provisions hereof not specifically amended
thereby shall remain in full force and effect.
11.14 Counterparts. This Agreement may be executed in counterparts, each of
which shall be deemed an original, but which together shall constitute
one and the same instrument.
IN WITNESS WHEREOF, the parties hereto have caused their duly authorized
representatives to execute this Agreement.
VIVUS, INC. NERAPHARM, SPOL. S. R. O.
By: /s/ ▇▇▇▇▇ ▇▇▇▇ By: /s/ Ing ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
-------------------------- ----------------------------
Name: ▇▇▇▇▇ ▇▇▇▇ Name: Ing ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
Title: Vice President Title: Managing Director and
Member of Board of Directors
Date: 01/07/04
-------------------------- Date: 12/22/03
----------------------------
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EXHIBIT A
SPECIFICATIONS TABLE
(**)
15
