1
EXHIBIT 10.31
MANUFACTURE AND SUPPLY AGREEMENT
This Manufacturing and Supply Agreement ("Agreement"), is entered into
as of May 30, 1997 ("Effective Date") by and between Vivus, Inc., having a
principal place of business at 000 Xxxxxxxxxxx Xxxx, Xxxxx 000, Xxxxx Xxxx, XX
00000, Xxxxxx Xxxxxx of America ("Vivus"), and Spolana Chemical Works, A.S.,
having a place of business at 000 00 Xxxxxxxxxx, Xxxxx Xxxxxxxx ("Spolana").
BACKGROUND
A. Spolana and Pharmatech, Inc., also known as Pharma Tech International, Inc.
("Pharmatech") have entered into a business arrangement pursuant to which
Spolana appointed Pharmatech as Spolana's exclusive worldwide distributor of
Alprostadil USP (Prostaglandin E(1)) and Pharmatech agreed to purchase certain
quantities of Alprostadil USP all as described in more detail in those certain
memoranda between Spolana and Pharmatech dated March 2, 1993 filed in the
archives of the commercial department of the zavod kvalifikovane chemie
[qualified chemistry company] and that certain agreement in the Czech language
dated September 23, 1994, as amended (collectively, the "Spolana-Pharmatech
Agreements").
B. Vivus, Spolana and Pharmatech entered into that certain agreement effective
as of June 23, 1993 (the "Supply Agreement") pursuant to which Spolana agreed to
manufacture Prostaglandins E(1) and E(2) and Pharmatech would supply quantities
of Prostaglandins E(1) and E(2) so manufactured to Vivus. Therein, Vivus agreed
not to purchase Prostaglandins E(1) and E(2) directly from Spolana during the
term of the Supply Agreement but only from Pharmatech.
C. Thereafter, Vivus and Pharmatech have entered into a certain letter agreement
dated March 17, 1997 pursuant to which Pharmatech agreed to waive or otherwise
terminate its rights under the Spolana-Pharmatech Agreements and the Supply
Agreement, so that Vivus may purchase Prostaglandins E(1) and E(2) directly from
Spolana and Spolana may supply the same directly to Vivus.
D. Vivus desires to secure a supply of certain quantities of Alprostadil
manufactured by Spolana; and Spolana desires to supply such Alprostadil directly
to Vivus, and not through Pharmatech, all on the terms and conditions set forth
below.
NOW, THEREFORE, in consideration of the mutual covenants and premises
herein contained, the parties hereto agree as follows:
ARTICLE 1.
DEFINITIONS
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 Spolana which is
adequate to comply with the applicable requirements and standards of such
regulatory agency with respect to the Product.
2
1.2. "FDA" shall mean the United States Food and Drug Administration.
1.3. "GMP" shall mean good manufacturing practices as defined by the
FDA in 21 CFR Part 211.
1.4. "MUSE System" shall mean Vivus' system for delivery of the
Product to treat erectile dysfunction, as modified from time to time during the
term of this Agreement.
1.5. "Product" shall mean Alprostadil USP (Prostaglandin E(1)).
1.6. "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.
1.7. "USP" shall mean United States Pharmacopeia.
ARTICLE 2.
SUPPLY
2.1. Product Supply. Subject to the terms and conditions of this
Agreement, Spolana shall supply to Vivus quantities of the Product ordered by
Vivus from time to time during the term of this Agreement. Without limiting the
foregoing, Spolana shall at all times maintain facilities to manufacture, [*].
2.2. Forecasts. During the term of this Agreement, [*], Vivus shall
provide Spolana with a rolling written forecast of the quantities of Product
estimated to be required [*]. Notwithstanding the foregoing, Vivus' initial
forecast of the quantities of Product estimated to be required [*] is attached
hereto as Exhibit B.
2.3. Orders.
2.3.1. Orders. Together with each forecast provided under
Section 2.2 above (the "Current Forecast"), [*]. Spolana shall accept such
orders from Vivus, subject to the remaining terms and conditions of this
Agreement, provided that Spolana [*]. All orders placed hereunder shall be for
full lots of 500 or 600 grams, or as otherwise mutually agreed.
*Confidential treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.
2
3
2.3.2. 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 Spolana and Vivus. Spolana shall use
all reasonable efforts to notify Vivus [*] of its ability to fill any amounts of
such order in excess of the quantities that Spolana 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.
2.3.3. Minimum Orders. Vivus agrees to order at least [*] of
Product for delivery during [*]. In addition, Vivus agrees to order [*].
2.4 Maximum Quantities. Notwithstanding anything herein to the
contrary, Spolana shall not be obligated to supply to Vivus more than [*],
provided that Spolana agrees to use all reasonable efforts to supply any
quantities in excess of such amount as Vivus may order in accordance with
Section 2.3 above.
2.5 Price. The price to be paid by Vivus per gram of the Product
ordered by Vivus shall be [*] by Spolana during a particular calendar year, as
follows:
2.5.1. [*];
2.5.2. [*];
2.5.3. [*]; and
2.5.4 [*].
[*].
2.6 Packaging. Products shall be shipped to Vivus in lots aliquoted to
500 or 600 grams each, packaged in containers in accordance with the United
States DMF. Each such container shall be individually labeled with a description
of its contents, including the manufacturer name, manufacturer lot number,
quantity of Product, and date of manufacture. Each such container shall be
resealable and protected from light and breakage. In addition, a separate
external plastic container shall be placed outside each such container, and
shall in turn be sealed within a heavy plastic bag. The shipment shall be
insured and carried by a reputable air freight company reasonably acceptable to
Vivus. 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
provided to Vivus.
*Confidential treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.
3
4
2.7 Shipping Terms; Payment. [*]. The manner of shipment shall be
designated by Spolana 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 Spolana's invoice. Payment terms shall be [*].
2.8 Taxes. [*]
ARTICLE 3.
QUALITY
3.1. Quality. All Product supplied by Spolana shall meet (i) the
current USP and European Pharmacopoeia requirements for the Product, (ii) the
current Specifications, (iii) additional requirements that the parties may agree
to from time to time to reflect to the manufacturing requirements of Vivus' MUSE
System and (iv) the requirements of any health regulatory agency to which Vivus
has submitted, or notifies Spolana it will submit or sponsor the submission of,
an application for regulatory approval. In case of any official monograph or
regulatory agency requirement conflicts with the current USP and European
Pharmacopoeia requirements for the Product and Spolana's manufacturing and
control process of Product described in the DMF, parties will consult to seek a
mutually acceptable solution. All Product supplied by Spolana shall be
manufactured in accordance with current GMP manufacturing and record keeping
procedures and ISO 9000 regulatory requirements and record keeping procedures at
Spolana's plant located at 27711 Neratovice, Czech Republic (the "Facility").
3.2. Quality Control. Prior to each shipment of Product, Spolana 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 a
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.
3.3. Rejection. Vivus shall have [*] 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 Spolana in Section 5.1, which
rejection shall be accomplished by giving written notice to Spolana 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 a satisfactory sample returned to Spolana to verify such
non-conformity. If Vivus rejects a shipment before the date on which payment
therefor is due, it may
*Confidential treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.
4
5
withhold payment for such shipment or the rejected portion thereof. The
warranties given by Spolana in Article 5 below shall survive any failure to
reject by Vivus under this Section 3.3.
3.4 Returns and Settlement of Claims. Spolana shall be obliged to
respond in writing to Vivus accepting or refusing a rejection notice from Vivus
[*] from the date of receipt of such rejection notice in accordance with Section
3.3 above. In case of a 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 Spolana as not
meeting the applicable requirements and Specifications or so decided by the
Laboratory shall be returned by Vivus to Spolana. Spolana shall use its best
efforts to replace the quantities of Product returned by Vivus within the
shortest possible time, [*] from the return of such quantities. The replacement
of returned Product shall have priority over the supply of Product ordered for
shipment, [*] or any time after the return of the rejected quantity to Spolana.
Without limiting the remedies of Vivus, if Spolana fails to replace returned
Product within [*] days from the date Product is returned to Spolana, 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 Spolana.
3.5. Presence At Facility. Upon reasonable notice given by Vivus to
Spolana 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 Spolana's
compliance with the current GMP and other agreed requirements, provided, however
that (a) such employees or consultants shall not unreasonably interfere with
other activities being carried out at the Facility, and (b) that such employees
or consultants shall observe all rules and regulations applicable to visitors
and to individuals employed at the Facility. It is understood that as of the
Effective Date Vivus has engaged Forum (Holdings) Limited ("Forum") pursuant to
that certain agreement dated September 26, 1996 pursuant to which Forum agreed
to assist Vivus in ensuring, by aiding Spolana, that Spolana meets and maintains
current GMP and requirements necessary for the sale of Product throughout the
world.
ARTICLE 4.
REGULATORY MATTERS
*Confidential treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.
5
6
4.1. Regulatory Approvals.
4.1.1. Requirements. Vivus and its marketing partners shall
notify Spolana 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 and Canada and other countries as is or becomes necessary for
Vivus and its marketing partners to import, export and sell the MUSE System
worldwide. Spolana will submit a DMF or its equivalent in any other country
imposing requirements fully identical that of United States, Canada or the
European Union within [*]. 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 Spolana, 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. Spolana 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. Spolana shall keep Vivus
and it 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. Spolana shall submit 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. Spolana agrees
to maintain all information filed with the FDA and other regulatory bodies
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, Spolana 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 System and/or other products worldwide.
Spolana 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. Spolana shall permit the FDA and other regulatory
agencies to conduct such inspections of the Facility as the FDA or such other
regulatory agencies may request, and shall cooperate with the FDA or such other
regulatory agencies with respect to such inspections and any related matters.
Spolana shall give Vivus prior written notice of any such inspections, and shall
keep Vivus informed about the results and conclusions of each such regulatory
inspection, including actions taken by Spolana to remedy conditions cited in
such inspections. In addition, Spolana shall allow Vivus or its representative
to assist in the preparation for and be present at such inspections.
*Confidential treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.
6
7
Spolana shall provide Vivus with copies of any written inspection reports issued
by such agencies and all correspondence between Spolana 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 Spolana, 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 Spolana reasonably
informed as to the status of the development and applications for regulatory
approvals of the MUSE System incorporating the Product supplied hereunder.
4.4 Maintenance of Approvals. Notwithstanding anything herein to the
contrary, Spolana shall not undertake any modifications to Product manufacturing
or testing processes, specifications or filings that could impact Vivus product
approvals, regulatory product reviews, IND or any other compliance status
without prior written agreement of Vivus. Spolana 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. Spolana warrants and
represents that:
5.1.1 Specifications. all Product supplied to Vivus hereunder
shall comply with the Specifications for the Product, 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 regulatory requirements for
commercialization of the Product, including without limitation maintenance of a
current DMF with the FDA, 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 other regulatory agencies with which a DMF has been
filed for the Product;
5.1.3 USP. all Product supplied to Vivus hereunder shall
meet all USP and European Pharmacopeia 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 Cosmetic Act, 21 U.S.C.A. Section 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
7
8
substantially similar meanings as the meanings of adulteration or misbranding
under the Act; provided, however, that this provision shall not apply to, and
Spolana 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 [*];
5.1.6 Notification. Spolana 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 such alteration, 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.
5.2 Disclaimer. EXCEPT AS EXPRESSLY PROVIDED IN THIS ARTICLE 5, SPOLANA
MAKES NO REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, AS TO THE PRODUCT, AND
SPOLANA 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
6.1 Term. The term of this Agreement shall commence on the Effective
Date and continue in full force [*], unless terminated earlier in accordance
with this Article 6.
6.2 Termination for Convenience. Either party hereto may terminate this
Agreement upon [*] prior written notice to the other party hereto; provided,
however, such termination shall not become effective [*].
6.3 Termination by Spolana. Spolana shall have the right to terminate
this Agreement on [*] prior written notice to Vivus after the beginning of any
calendar year during the term of this Agreement but before [*].
*Confidential treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.
8
9
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 [*] after being given written notice thereof.
6.5 Effect of Termination. In the case of notice of termination by
either party under Section 6.3 or 6.4, the parties' obligations, including
Spolana'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 Spolana agrees to supply
quantities of Product for which Vivus has not found alternate suppliers, at
Spolana'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 3.3, 3.4, 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
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 [*] after 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; (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; or (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 treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.
9
10
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 agrees to be 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.
ARTICLE 8.
REPRESENTATIONS AND WARRANTIES
8.1 Spolana. Spolana 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) Spolana 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 approvals
to enter and execute into this Agreement; (iii) it has not entered and will not
enter into any agreements with 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,
10
11
IMPLIED, STATUTORY OR OTHERWISE) WITH RESPECT TO THE SUBJECT MATTER
HEREOF.
ARTICLE 9.
INDEMNIFICATION
9.1 Vivus. Vivus shall indemnify, defend and hold harmless Spolana, 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 [*], 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 Spolana. Spolana 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 [*], 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 the 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.
10.2. Government Approvals. Spolana shall:
*Confidential treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.
11
12
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 Spolana 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 Products 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.
12
13
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.
If to Vivus: Vivus, Inc.
000 Xxxxxxxxxxx Xxxx, Xxxxx 000
Xxxxx Xxxx, XX 00000
Attn: C.E.O. and C.F.O.
with a copy to: Wilson, Sonsini, Xxxxxxxx & Xxxxxx
000 Xxxx Xxxx Xxxx
Xxxx Xxxx, Xxxxxxxxxx 00000-0000
Attn: Xxxxxxx X. Xxxxx, Esq.
If to Spolana: Spolana a.s.
277 11 Neratovice
Czech Republic
Attn: Odd. podeje KCH-OU
with a copy to: _____________________________
_____________________________
_____________________________
_____________________________
_____________________________
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.
13
14
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.
11.11 Independent Contractors. The relationship of Vivus and Spolana
established by this Agreement is that of independent contractors. Nothing in
this Agreement shall be construed to create any other relationship between Vivus
and Spolana. 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. Spolana 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. Spolana 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 hereof. 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
14
15
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. SPOLANA CHEMICAL WORKS, A.S.
By: By:
---------------------------- ---------------------------------
Name: Name:
--------------------------- -------------------------------
Title: Title:
-------------------------- -------------------------------
15
16
EXHIBIT A
[*]
*Confidential treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.
17
EXHIBIT B
INITIAL FORECAST
MANUFACTURE and SUPPLY AGREEMENT
[*]
*Confidential treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.
