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EXHIBIT 10.34
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MARKETING AND PROMOTIONAL SERVICES AGREEMENT
BY AND BETWEEN
NOVEN PHARMACEUTICALS INC.
AND
VIVELLE VENTURES LLC
Dated as of May 1, 1998
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MARKETING AND
PROMOTIONAL SERVICES AGREEMENT
This Marketing and Promotional Services Agreement (the "Agreement") is
made this 1st day of May, 1998, by and between Noven Pharmaceuticals Inc., a
Delaware corporation ("Noven") and Vivelle Ventures LLC, a Delaware limited
liability company (such entities hereafter also referred to individually as a
Party or collectively as the "Parties").
W I T N E S S E T H:
WHEREAS, Noven and Novartis Pharmaceuticals Corporation, a Delaware
corporation ("Novartis") have entered into a Formation Agreement dated as of
May 1, 1998 (the "Formation Agreement"), whereby they have formed Vivelle
Ventures LLC for the purpose of creating a platform to maintain and grow a
franchise in women's health, focusing initially on the manufacture, marketing
and sale of the 17 Beta-estradiol single active ingredient product in a
transdermal matrix currently being marketed by Novartis under the trademark
"Vivelle" pursuant to the License Agreement;
WHEREAS, in connection with the formation of Vivelle Ventures LLC, Noven
has agreed to enter into this Agreement to provide marketing, sales,
promotional and related services to Vivelle Ventures LLC.
NOW, THEREFORE, in consideration of the foregoing and the respective
representations, warranties, covenants and agreements contained herein, and
intending to be legally bound hereby, the Parties agree as follows:
ARTICLE I
DEFINITIONS AND PRINCIPLES OF CONSTRUCTION
Section 1.1 Definitions. For purposes of this Agreement, the following
terms shall be defined as follows:
"Affiliate" of any Person means any other entity or Person controlling,
controlled by, or under common control with, such entity or Person. For
purposes of this definition, "control" means the possession, directly or
indirectly, of the power to direct or cause the direction of the management and
policies of a Person, whether by ownership of voting securities, by contract or
otherwise.
"Approval" means any and all approvals, registrations, licenses,
authorizations, visas, price approvals, drug identification numbers, or permits
required by any GRB within the Territory in order to import, offer for sale,
sell, market, manufacture, have made or use the Product in the Territory.
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"Consent" means any approval, waiver or authorization of, or filing or
registration with, or notification to, any Person.
"Direct Costs and Expenses" means all fixed and variable costs and
expenses, including overhead, determined in accordance with generally accepted
accounting principles in effect in the United States consistently applied,
incurred by Noven in connection with providing the Services contemplated under
this Agreement.
"Distribution and Services Agreement" means that certain Distribution and
Services Agreement dated as of May 1, 1998 by and between Novartis and Vivelle
Ventures LLC.
"Formation Agreement" means the Formation Agreement dated as of May 1,
1998 between Noven and Novartis.
"GRB" means the U.S. Food and Drug Administration or any other government
regulatory body of a country where the Product is to be sold or distributed
which has authority over clinical testing, manufacturing, marketing and sale of
pharmaceutical products.
"GMP" means good manufacturing practice as required by GRB regulations.
"Governmental Authority" means any court, agency or commission or other
governmental authority or instrumentality, whether domestic or foreign.
"Internal Accounts" shall have the meaning set forth in Section 4.4
hereof.
"License Agreement" means that certain Restated License Agreement dated as
of November 15, 1991 by and between Noven, as licensor, and Ciba, as licensee,
the rights and obligations of Ciba pursuant to which Novartis has assumed as
the successor-in-interest to Ciba.
"Limited Assignment Agreement" means that certain Limited Assignment
Agreement dated as of May 1, 1998 by and among Novartis, Noven and Vivelle
Ventures LLC.
"Operating Agreement" means that certain operating agreement of Vivelle
Ventures LLC dated as of May 1, 1998.
"Person" means any individual, firm, corporation, partnership or other
entity.
"Product" means Vivelle.
"Product Application" means a formal application seeking approval to
manufacture, market and sell a Product within a country in the Territory
submitted by Vivelle Ventures LLC to the appropriate GRB under applicable laws,
or such application owned by Vivelle Ventures LLC, including any Abbreviated
New Drug Application (ANDA) or New Drug Application (NDA), as defined in the
U.S. Federal Food, Drug and Cosmetic Act and applicable regulations promulgated
thereunder, as such are from time to time amended.
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"Product Packaging" means the packaging and trade dress of the Product as
determined by Vivelle Ventures LLC including the proprietary marks of the
Product licensed to Vivelle Ventures LLC by Novartis pursuant to the Trademark
License.
"Product Specification" means Vivelle Ventures LLC's specifications for
the Product as set forth in the applicable Product Application, as such
specification may be amended from time to time, either by Vivelle Ventures LLC
itself or in response to directives issued by a relevant Governmental
Authority.
"Services" means those marketing, promotional, sales and related services
provided to Vivelle Ventures LLC by Noven or Noven's Affiliates or designees
pursuant to this Agreement as set forth in Schedule A hereto, as such Schedule
may be amended from time to time, or such other services as Noven and Vivelle
Ventures LLC may agree.
"Supply Agreement" means that certain Supply Agreement dated as of August
31, 1995 by and between Noven and Ciba, the rights and obligations of Ciba
pursuant to which Novartis has assumed as the successor-in-interest to Ciba.
"Territory" means the United States, its territories and possessions.
"Trademark License" means the Trademark License Agreement between Novartis
and Vivelle Ventures LLC dated as of May 1, 1998 whereby Novartis has granted a
license to Vivelle Ventures LLC to market, distribute and sell pharmaceutical
products bearing the Vivelle trademark.
"Vivelle" means the 17 Beta-estradiol single active ingredient product in
a matrix which Novartis has been marketing and will continue to market up
through the Closing Date (as defined in the Formation Agreement) under the
trademark Vivelle pursuant to the License Agreement.
"Vivelle II" means the second generation product of Vivelle which has been
designated by Noven as G2E2.
Section 1.2 Monetary Terms. All monetary terms set forth herein are
expressed in U.S. dollars.
Section 1.3 Hereof. The words "hereof," "herein," "hereto," "hereunder"
and "hereinafter" and words of similar import, when used in this Agreement,
shall refer to this Agreement as a whole and not to any particular provision of
this Agreement.
Section 1.4 Plural and Singular. The terms defined in the singular shall
have a comparable meaning when used in the plural, and vice versa.
Section 1.5 Including. The word "including" shall mean including, without
limitation, and the words include and "includes" shall have corresponding
meanings.
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ARTICLE II
PURPOSE
Section 2.1 Purpose. This Agreement sets forth an identification of the
Services and the terms and conditions under which Noven shall provide such
Services to Vivelle Ventures LLC within the Territory.
ARTICLE III
SERVICES
Section 3.1 Services. At the direction of Vivelle Ventures LLC, Noven
shall provide, or cause a Noven Affiliate to provide, Vivelle Ventures LLC with
Services in connection with the business of Vivelle Ventures LLC, as set forth
in Schedule A, as may be amended from time to time by mutual agreement of Noven
and Vivelle Ventures LLC. Noven agrees to provide the Services (or cause the
Services to be provided by an Affiliate) in a competent manner consistent with
industry standards for like services performed by third parties on their own
behalf.
Section 3.2 Timing Of Performance. Noven and/or its Affiliates furnishing
Services under this Agreement shall use commercially reasonable efforts to
provide the Services in a timely manner; provided, however, that neither Noven
nor any of its Affiliates shall be liable to Vivelle Ventures LLC and/or any of
its Affiliates for any delay damages or penalties.
Section 3.3 Independent Contractor. At all times during the term hereof,
Noven shall be an independent contractor in providing Services hereunder with
the sole right to supervise, manage, operate, control, and direct the
performance of such Services and the sole obligation to employ, compensate, and
manage its employees and business affairs. Nothing contained in this Agreement
shall be deemed or construed to create a partnership or joint venture, to
create the relationships of employee/employer or principal/agent, or otherwise
create any liability whatsoever of either Party with respect to the
indebtedness, liabilities, obligations or actions of the other or any of their
employees or agents, or any other person or entity.
Section 3.4 Adverse Incident Reporting. During the term of this Agreement,
each party shall immediately notify the other of any information (howsoever
obtained and from whatever source) concerning any unexpected side effect,
injury, toxicity or sensitivity reaction, or any unexpected incidence, and the
severity thereof, associated with the clinical uses, studies, investigations,
testing and marketing of the Product. During such times, each Party shall
further notify the other immediately of any information received regarding any
threatened or pending action by any GRB which may affect the safety and
efficacy claims of the Product. Upon receipt of any such information, the
parties shall consult with each other in an effort to arrive at a mutually
acceptable procedure for taking appropriate action; provided, however, that
nothing contained herein shall be construed as restricting either party's right
to make a timely report of
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such matter to any GRB or take other action that it deems to be appropriate or
required by applicable law or regulation.
Section 3.5 Documentation. Subject to confidentiality restrictions from
third-parties and applicable laws and regulations relating to retention and/or
disclosure of information, in the event that Novartis purchases all of Noven's
Interest (as that term is defined in the Operating Agreement) in Vivelle
Ventures LLC pursuant to Section 9.5 of the Operating Agreement, Noven shall
promptly provide all the books, records, files, studies, correspondence and
other documents created or received by Noven in the course of providing the
Services to the extent such information does not disclose confidential,
proprietary or commercial information relating to Noven's own business.
ARTICLE IV
COMPENSATION
Section 4.1 Payment of Direct Costs and Expenses; Advances. (a) Noven
shall not charge Vivelle Ventures LLC for providing Services but shall be
reimbursed for all of Noven's Direct Costs and Expenses attributable to
providing Services hereunder. Noven shall invoice Vivelle Ventures LLC and
Vivelle Ventures LLC shall reimburse Noven for all such Direct Costs and
Expenses on a monthly basis .
(b) Vivelle Ventures LLC agrees to advance Noven funds on a monthly basis
necessary to pay Noven's Direct Costs and Expenses attributable to the
retention and operation of a contract sales force; provided that Noven (i)
submits a written estimate of its projected Direct Costs and Expenses
attributable to the foregoing and (ii) promptly remits to Vivelle Ventures LLC
any advanced amounts not actually expended for the foregoing purpose.
Section 4.2 Method and Timing of Payment. Any payment made by Vivelle
Ventures LLC to Noven hereunder shall be made by wire transfer or, at the
option of Noven, by check, in U.S. dollars to the account designated by Noven.
Payment by Vivelle Ventures LLC shall be deemed to have been made as of the day
on which such payment is received at the account designated by Noven. Unless
otherwise specified herein, all monthly payments under this Agreement will be
due no later than the first business day after the fifteenth (15th) day of the
subject month. If Vivelle Ventures LLC fails to make a timely payment due under
this Agreement, interest at an annual rate equal to the Yield of a Corporate
Bond (as such term is defined in the Operating Agreement) plus 250 basis points
shall accrue on the amount of payment for each day such payment is overdue,
provided that such interest shall in no event exceed the maximum rate permitted
by applicable law.
Section 4.3 Withholding Taxes. Any withholding or other taxes that Vivelle
Ventures LLC or any of its Affiliates are required by law to withhold or pay on
behalf of Noven with respect to the payments to Noven under this Agreement
shall be deducted from such payments to Noven and paid contemporaneously with
the remittance to Noven; provided,
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however, that in regard to any tax so deducted Vivelle Ventures LLC shall
furnish Noven with proper evidence of the taxes paid on its behalf. Noven will
furnish Vivelle Ventures LLC with appropriate documents to secure application
of the most favorable rate of withholding tax under applicable tax treaties.
Section 4.4 Internal Accounts; Accounting Methodology. Noven shall
initially apply its internal accounting principles and methodology in
determining its Direct Costs and Expenses. The accounting principles and
methodology used to determine Direct Costs and Expenses must be consistent with
U.S. generally accepted accounting principles and shall be reviewed and
approved by the Management Committee of Vivelle Ventures LLC prior to Noven
providing any Services for which it will seek reimbursement. If Vivelle
Ventures LLC disagrees as to the accounting principles or methodology adopted
by Noven, it shall request Noven to make necessary changes or adjustments. If
Noven objects to such changes or adjustments, the matter shall be submitted to
dispute resolution in accordance with Article XII of the Operating Agreement.
The accounting principles and methodology of Noven approved by Vivelle Ventures
LLC shall be applied during the term of this Agreement, unless any material
changes are made thereafter in which case a separate approval must be obtained
from Vivelle Ventures LLC with respect to any material changes. The internal
accounts (the "Internal Accounts") prepared by Noven applying the accounting
principles and methodology approved by Vivelle Ventures LLC to Noven's Direct
Costs and Expenses relating to Services provided hereunder, must be submitted
to Vivelle Ventures LLC for approval by the Management Committee on an annual
basis.
Section 4.5 Books, Records and Inspection Rights. Noven shall maintain
complete and accurate books and records in connection with the Services it
provides to Vivelle Ventures LLC for the sole of purpose of documenting Direct
Costs and Expenses. Upon reasonable written request of Vivelle Ventures LLC,
Noven shall permit representatives of Vivelle Ventures LLC to inspect or to use
an independent accounting firm to audit, in each case at Vivelle Ventures LLC's
own expense, the Internal Accounts of Noven.
Section 4.6 Market Rate for Services. In the event Vivelle Ventures LLC
believes that the Direct Costs and Expenses for any Service provided under this
Agreement substantially exceeds the market rate for said Services and provides
Noven with appropriate evidence of the market rate for said Service, Noven
shall at its sole discretion either provide said Service at the existing market
rate or consent to Vivelle Ventures LLC contracting the service to a third
party at the specified market rate. In the event that Noven consents to the
Service being performed by a third party contractor, Noven shall be released
from any obligation under this Agreement to provide said Service and Vivelle
Ventures LLC shall agree to indemnify and hold Noven harmless for any loss
incurred by Noven as a result of the third party providing said Service.
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ARTICLE V
CONFIDENTIALITY
Section 5.1 Confidentiality.
(a) Each Party acknowledges that the information disclosed in connection
with the activities contemplated hereunder may contain confidential information
of the disclosing Party ("Confidential Information"), and that any such
Confidential Information shall remain the property of the disclosing Party
(such Party hereinafter referred to as the "Disclosing Party"). Each Party
agrees, covenants and acknowledges that, except to the extent expressly
permitted by this Agreement or as otherwise agreed to by the Parties in
writing, from and after the date of this Agreement, it will not disclose, give,
sell, use or otherwise divulge any Confidential Information received from the
Disclosing Party (whether written or oral) which is marked as CONFIDENTIAL or
orally indicated to be confidential and subsequently confirmed in writing as
confidential within thirty (30) days after its disclosure.
(b) Each Party agrees, covenants and acknowledges that from and after the
date of this Agreement, it will exercise the same degree of care with respect
to protecting the Confidential Information of the Disclosing Party as the care
it exercises with respect to its own Confidential Information.
(c) In the event a Party or its respective employees, officers, directors
or advisors, who have received Confidential Information (hereafter the
"Recipient"), become legally compelled to disclose any Confidential
Information, such Recipient shall provide the Disclosing Party with prompt
written notice of such requirement so that such Disclosing Party may seek a
protective order or other remedy or waive compliance with this Section 5.1. In
the event that such protective order or other remedy is not obtained, or such
Disclosing Party waives compliance with this Section 5.1, then the Recipient
shall furnish only that portion of Confidential Information which is legally
required to be provided and exercise its best efforts to obtain assurances that
appropriate confidential treatment will be accorded the Confidential
Information.
(d) The confidentiality and restrictive use obligations under this Section
5.1 shall not apply to (i) any information that, at the time of disclosure, is
or subsequently becomes available publicly; provided, however, that such
information was not disclosed in breach of this Agreement by the Recipient or
any of its Affiliates or their respective employees, officers, directors or
advisors, or (ii) is hereafter made available to the Recipient from a source
other than the Disclosing Party, which source did not obtain same from the
Disclosing Party and did not impose an obligation of confidentiality on the
Recipient.
(e) The Parties recognize that the performance of the obligations under
this Section 5.1 are special, unique and extraordinary in character, and that
in the event of the breach by either Party or their Affiliates or their
respective employees, officers, directors or advisors of the terms and
conditions of this Section 5.1, the Disclosing Party shall be entitled, if it
so elects, to institute and prosecute proceedings in any court of competent
jurisdiction, either at law or in equity, to enforce the specific performance
thereof by such Party or to enjoin such Party or their
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Affiliates or their respective employees, officers, directors or advisors from
violating the provisions of this Section 5.1.
ARTICLE VI
INSURANCE
Section 6.1 Insurance. At its sole cost and expense, Vivelle Ventures LLC
agrees to obtain and maintain product liability, clinical trial liability (as
applicable) and environmental liability insurance (with Noven named as an
additional insured), with an insurer rated "A" or better by A.M. Best, in an
amount agreed upon by the Management Committee of Vivelle Ventures LLC. Such
insurance may not be canceled, modified or terminated except upon (30) days'
prior written notice to Noven. From time to time, at the request of Noven,
Vivelle Ventures LLC will cause certificates of such insurance to be supplied
to Noven evidencing compliance with the obligations set forth herein. Vivelle
Ventures LLC shall not assert against Noven, and Vivelle Ventures LLC hereby
waives, any and all claims against Noven for damages imposed upon or incurred
by Vivelle Ventures LLC arising out of, based upon or resulting from any claim
covered by such insurance.
ARTICLE VII
INDEMNIFICATION
Section 7.1 Indemnification. Vivelle Ventures LLC hereby agrees to
indemnify, defend and hold harmless Noven from and against any and all claims,
losses, demands, costs, or liabilities, including reasonable attorneys' fees,
resulting from or in connection with third party claims arising from Noven's
performance of the Services hereunder, unless such third party claims are due
to Noven's gross negligence or willful misconduct in performing Services. Such
indemnification shall survive the termination of this Agreement. Promptly upon
receipt by Noven of notice of the assertion of any third party claim in respect
to which indemnity may be sought against Vivelle Ventures LLC pursuant to this
Section 7.1, Noven shall notify Vivelle Ventures LLC in writing thereof; but
the omission to so notify Vivelle Ventures LLC will not relieve Vivelle
Ventures LLC from any liability which it may have to Noven under this Section
7.1, except to the extent such failure to so notify materially prejudices the
ability of Vivelle Ventures LLC to defend against such action. In defending
against the claim, Vivelle Ventures LLC shall have the right to employ counsel
of its own choosing and shall at all times have the power to direct the defense
against the claim. Noven shall provide such assistance and cooperation, at
Vivelle Ventures LLC's cost, as Vivelle Ventures LLC may reasonably request in
connection with the defense of any claim with respect to which indemnity may be
sought against Vivelle Ventures LLC pursuant to this Section 7.1.
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ARTICLE VIII
WARRANTY DISCLAIMER
Section 8.1 Warranty Disclaimer. In performing the Services, Noven and/or
its Affiliates performing the Services under this Agreement will use the same
degree of care as it exercises when performing like services for itself or for
its Affiliates. Any and all work performed or decisions made by Vivelle
Ventures LLC and/or its Affiliates or others, in reliance on information, data,
or other analysis furnished by Noven and/or its Affiliates under this Agreement
shall be at the sole risk and expense of Vivelle Ventures LLC and/or its
Affiliates. Noven and its Affiliates performing the Services under this
Agreement shall have no liability whether in contract, breach of contract, tort
(including negligence), warranty, breach of warranty, strict liability or
otherwise for the Services performed hereunder. NO WARRANTIES OR GUARANTEES OF
ANY NATURE (INCLUDING THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR
PURPOSE) ARE EXPRESSED NOR ARE ANY TO BE IMPLIED IN FACT OR IN LAW FOR THE
SERVICES TO BE PROVIDED BY NOVEN AND/OR ITS AFFILIATES HEREUNDER.
ARTICLE IX
FORCE MAJEURE
Section 9.1 Force Majeure.
(a) The excuse of "Force Majeure" can be claimed by Noven and/or its
Affiliates performing the Services under this Agreement in the event that the
failure of Noven and/or failure of its Affiliate to perform any term, condition
or obligation of the Agreement when due, other than the payment of money, is
caused by:
(i) acts of God or the public enemy, fire, explosion, perils of the
sea, flood, drought, war, riot, sabotage, accident, embargo, destruction
of production or transportation facilities; or
(ii) interruption of or delay in transportation, inadequacy or
shortage or failure of normal sources of supply of materials, or equipment
breakdowns, labor trouble from whatever cause arising including strikes
and lockouts and whether or not the demands of the employees involved are
reasonable and within Noven's or its Affiliate's power to concede; or
(iii) voluntary or involuntary compliance with any order, action, or
direction of any court, governmental officer, department, agency,
authority, or committee thereof, which renders it impossible for Noven or
its Affiliates to perform hereunder; or
(iv) any other extraordinary cause not within the reasonable control
of Noven or its Affiliate affected which, despite the exercise of
reasonable diligence, Noven or its Affiliate is unable to prevent, avoid
or remove.
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(b) In the event that Noven and/or its Affiliate is prevented or delayed
in the performance of any term, condition or obligation under this Agreement
due to Force Majeure, Noven and/or its Affiliate affected by Force Majeure,
shall give prompt notice to Vivelle Ventures LLC of the commencement, expected
duration and termination of any such Force Majeure contingency. Such
nonperformance shall be excused and the time for performance extended for the
period of delay or inability to perform due to such Force Majeure and the
consequences thereof.
(c) In each such instance, Noven and/or its Affiliate claiming Force
Majeure must show to the reasonable satisfaction of Vivelle Ventures LLC and/or
its Affiliate the existence of the event or occurrence constituting a permitted
delay and the necessity for a delay in performance of the affected obligation
of Noven and/or its Affiliates. Whenever possible, Noven and/or its Affiliate
claiming Force Majeure shall endeavor to use commercially reasonable efforts to
perform in spite of the Force Majeure.
ARTICLE X
MISCELLANEOUS
Section 10.1 Notices. All notices, requests, demands and other
communications hereunder shall be given in writing and shall be: (a) personally
delivered; (b) sent by telecopier, facsimile transmission or other electronic
means of transmitting written documents; or (c) sent to the Parties at their
respective addresses indicated herein by registered or certified U.S. mail,
return receipt requested and postage prepaid, or by private overnight mail
courier service. The respective addresses to be used for all such notices,
demands or requests are as follows:
(a) If to Vivelle Ventures LLC, to:
c/o Noven Pharmaceuticals Inc.
00000 X.X. 000xx Xxxxxx
Xxxxx, XX 00000
Attention: Xx. Xxxxxx X. Xxxxxxx, President
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
with copies to:
Novartis Pharmaceuticals Corporation
00 Xxxxx 00
Xxxx Xxxxxxx, XX 00000
Attention: Xxxxxx Xxxxxxx, Esq., Legal Department
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
and
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White & Case LLP
0000 Xxxxxx xx xxx Xxxxxxxx
Xxx Xxxx, XX 00000
Attention: Xxxxxxx X. Xxxxx, Xx., Esq.
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
or to such other person or address as Vivelle Ventures LLC shall furnish
to Noven in writing.
(b) If to Noven, to:
Noven Pharmaceuticals Inc.
00000 X.X. 000xx Xxxxxx
Xxxxx, XX 00000
Attention: Xx. Xxxxxx X. Xxxxxxx, President and CEO
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
with a copy to:
Xxxxx & Xxxxxxx
0000 X Xxxxxx, X.X.
Xxxxx 000
Xxxxxxxxxx, X.X. 00000
Attention: Xxxxx Xxxxx, Esq.
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
or to such other person or address as Noven shall furnish to Vivelle
Ventures LLC in writing.
If personally delivered, such communication shall be deemed delivered upon
actual receipt; if electronically transmitted pursuant to this paragraph, such
communication shall be deemed delivered on the day transmitted unless it is
received after 5:00 p.m. New York time, or on a day which is not a business
day, in which case it shall be deemed delivered on the next business day after
transmission (and sender shall bear the burden of proof of delivery); if sent
by overnight courier pursuant to this paragraph, such communication shall be
deemed delivered upon receipt; and if sent by U.S. mail pursuant to this
paragraph, such communication shall be deemed delivered as of the date of
delivery indicated on the receipt issued by the relevant postal service, or, if
the addressee fails or refuses to accept delivery, as of the date of such
failure or refusal. Any Party may change its address for the purposes of this
Agreement by giving notice thereof in accordance with this Section.
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Section 10.2 Entire Agreement; Assignment. This Agreement, including the
exhibits and schedules hereto and the documents, schedules, certificates and
instruments referred to herein, and the Operating Agreement constitute the
entire agreement, and supersede all prior agreements and understandings, both
written and oral, among the parties with respect to the subject matter hereof.
No amendment or modification to this Agreement shall be valid or binding upon
the parties unless made in writing and signed by the representatives of such
parties. Except as otherwise expressly permitted hereby, this Agreement shall
not be assigned by operation of law or otherwise.
Section 10.3 Parties in Interest. This Agreement shall be binding upon and
inure solely to the benefit of each Party hereto, and nothing in this Agreement
shall be deemed to confer upon any other Person any right or remedy under or by
reason of this Agreement.
Section 10.4 Law Governing Agreement. THIS AGREEMENT SHALL BE CONSTRUED
AND INTERPRETED ACCORDING TO THE INTERNAL LAWS OF THE STATE OF NEW YORK,
EXCLUDING ANY CHOICE OF LAW RULES THAT MAY DIRECT THE APPLICATION OF THE LAWS
OF ANOTHER JURISDICTION.
Section 10.5 Expenses. Each of the Parties shall bear its own expenses and
the expenses of its counsel and other agents in connection with the
transactions contemplated hereby.
Section 10.6 Headings. The headings in this Agreement are inserted for
convenience only and shall not constitute a part hereof.
Section 10.7 Counterparts. This Agreement may be executed in one or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument. Delivery of an executed
counterpart of a signature page to this Agreement by telecopier shall be as
effective as delivery of a manually executed counterpart of this Agreement.
Section 10.8 Mutual Drafting Acknowledgment. This Agreement is the result
of the joint efforts of the Parties hereto and each provision hereof has been
subject to the mutual consultation, negotiation and agreement of the parties
and their counsel, and there shall be no construction against any Party based
upon any presumption of that Party's involvement in the drafting hereof.
Section 10.9 Cooperation.. Each of the Parties hereto shall use
commercially reasonable efforts to take or cause to be taken all action, to
cooperate with the other Party hereto with respect to all actions, and to do or
cause to be done all things necessary, proper or advisable to consummate the
transactions contemplated by this Agreement.
Section 10.10 Term and Termination of this Agreement. This Agreement shall
terminate at the earlier to occur of (i) the dissolution of Vivelle Ventures
LLC in accordance with the provisions of Article X of the Operating Agreement,
(ii) the purchase by Novartis of Noven's interest in Vivelle Ventures LLC,
(iii) the permitted transfer of Noven's interest in Vivelle Ventures LLC to an
unaffiliated third-party in accordance with Section 9.1 of the Operating
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Agreement, (iv) the mutual agreement of the Parties, (v) the election of the
non-breaching Party in the event of a material breach of this Agreement
provided that the non-breaching Party notifies the breaching Party in writing
of such breach and the breaching Party does not cure the breach within thirty
(30) days after receiving the notice and (vi) the election of a Party in the
event of the liquidation, dissolution, winding-up, insolvency, bankruptcy, or
filing any petition therefor, appointment of a receiver, custodian or trustee,
or any other similar proceeding, by or of the other Party.
Section 10.11 Dispute Resolution. The Parties agree that unresolved
disputes between them relating to this Agreement shall be resolved in
accordance with Article XII of the Operating Agreement.
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IN WITNESS WHEREOF, the Parties hereto have duly executed this Agreement
as of the date and year first above written.
VIVELLE VENTURES LLC
By: /s/ Xxxxxx X. Xxxxxxx
-----------------------------------------
Title: President
NOVEN PHARMACEUTICALS INC.
By: /s/ Xxxxxx Xxxxxxxxx
-----------------------------------------
Title: Chairman
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Schedule A
Technical Services
1. Retention of Samples and Documentation. Noven shall take and retain, for
such period as may be required under GRB regulations, representative
samples of Product from each lot specifying its date of manufacture and
packaging. In addition, Noven shall maintain and archive all other
appropriate documents for so long as directed by Vivelle Ventures LLC but
in no event shorter than a period in accordance with applicable GRB
guidelines.
2. Packaging. Noven shall package unfinished dosage forms of Product in
accordance with the Product Packaging.
Product Shipment
1. Noven shall be responsible for arranging for the shipment of finished
pre-packaged dosage forms of Product from the relevant manufacturing
and/or packaging facility to a location designated by Novartis.
Sales and Marketing Services
1. Marketing and Promotions. As directed by Vivelle Ventures LLC, Noven shall
design and implement an overall marketing and sales program for the
Product in the hospital and retail sales sectors of the overall market. In
particular, Noven shall prepare annual and quarterly marketing plans which
shall be submitted to the Management Committee of Vivelle Ventures LLC for
approval. Each marketing plan shall, at a minimum, propose target sales
levels for each Product, address marketing strategies and programs for
Products, discuss the overall position of each Product in its relative
market, and propose a budget for upcoming marketing expenditures. It is
anticipated that a similar arrangement will apply in the event that
Vivelle Ventures LLC decides to promote future products.
2. Sales. At the direction of Vivelle Ventures LLC, Noven shall staff, either
directly or by contract, a sales field force to detail the Product to the
hospital and retail sales sectors of the market, including, without
limitation, physicians offices. The sales force shall be comprised of
qualified pharmaceutical sales representatives. Noven shall communicate
all orders for Product to Novartis who shall be responsible for filling
said orders and shipping Product to distributors and customers.
3. Advertising. Noven shall be responsible for procuring the services of an
advertising agency in connection with the marketing and promotion of the
Product, which advertising agency shall be subject to the pre-approval of
both Vivelle Ventures LLC and Novartis, such approval not to be
unreasonably withheld.
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Noven shall further be responsible for directing and overseeing on Vivelle
Ventures LLC's behalf the services provided by such advertising agency.
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