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EXHIBIT 10.1
DEVELOPMENT AGREEMENT
between
NOVARTIS PHARMA AG
and
NOVEN PHARMACEUTICALS, INC.
JUNE 1, 2001
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DEVELOPMENT AGREEMENT
THIS DEVELOPMENT AGREEMENT (this "AGREEMENT"), dated as of June 1, 2001, is by
and between NOVARTIS PHARMA AG, a corporation organized under the laws of
Switzerland with its principal office at Xxxxxxxxxxxx 00, XX-0000 Xxxxx,
Xxxxxxxxxxx ("NOVARTIS"), and NOVEN PHARMACEUTICALS, INC., a Delaware
corporation with its principal office at 00000 X.X. 000xx Xxxxxx, Xxxxx, Xxxxxxx
00000 ("NOVEN") (Novartis and Noven are collectively referred to herein as the
"PARTIES").
RECITALS
WHEREAS, Xxxxx-Xxxxxxx Xxxxx Pharmaceuticals, Inc. and Noven are
parties to an Amended and Restated License Agreement dated as of September 30,
1999, as amended by Amendment No. 2 thereto effective as of March 28, 2001
(collectively, the "NOVEN LICENSE AGREEMENT"), pursuant to which Noven granted
Xxxxx-Xxxxxxx Xxxxx Pharmaceuticals, Inc. an exclusive right and license under
Noven's Patent Rights and Noven's Technology (each as defined in the Noven
License Agreement) to develop, use, sell or otherwise dispose of Licensed
Products (as defined in the Noven License Agreement);
WHEREAS, Xxxxx-Xxxxxxx Xxxxx Pharmaceuticals, Inc. assigned the Noven
License Agreement to XXXXX PHARMACEUTICAL PRODUCTS, INC, a Delaware corporation
(hereinafter referred to as "AVENTIS") pursuant to an Assignment and Assumption
Agreement dated September 30, 1999;
WHEREAS, Novartis and Aventis have previously entered into a Sublicense
Agreement (the "EXISTING NOVARTIS PHARMA SUBLICENSE AGREEMENT") dated as of
September 30, 1999, pursuant to which Aventis granted to Novartis certain of its
rights related to "licensed product" in the "territory" (each as defined in the
Existing Novartis Pharma Sublicense Agreement); and
WHEREAS, Novartis, Noven, Aventis and several of Aventis' affiliates
have entered into a Sublicense Agreement (the "IMPROVEMENTS SUBLICENSE
AGREEMENT") dated as of March 29, 2001, pursuant to which Aventis granted to
Novartis a sublicense to all rights and benefits of Aventis and its Affiliates
arising out of or under the Noven License Agreement in the Territory (as defined
in the Noven License Agreement), including the right to develop Licensed
Products; and
WHEREAS, Novartis and Noven desire to develop Licensed Products and
wish to establish the terms under which such development activity will be
pursued, all on the terms and conditions contained in this Agreement;
WHEREAS, if the development is successful and Novartis decides to
market the products resulting therefrom, Novartis shall purchase and Noven shall
supply at Novartis' request all of its, its Affiliates' and sublicencees'
worldwide requirements of the Development Products (as defined hereinafter) from
Noven under a supply agreement to be negotiated.
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NOW, THEREFORE, in consideration of the mutual covenants and
considerations set forth herein, the Parties hereto, intending to be legally
bound, hereby agree as follows:
ARTICLE I
DEFINITIONS
1.1. DEFINITIONS. As used herein, the following capitalized terms shall
have the following meanings:
"AFFECTED PARTY" has the meaning set forth in Section 7.3 hereof.
"AFFILIATE" means, when used with respect to a Person, any other Person
directly or indirectly controlling, controlled by, or under common control with
the subject Person. For purposes of this Agreement, "control" means the direct
or indirect ownership of over 50% of the outstanding voting securities of a
Person, or to control the management decisions of such Person.
"AUTHORIZED REPRESENTATIVE" means, with respect to Noven, any Vice
President, and with respect to Novartis, a Novartis representative responsible
for product development co-signing with another Novartis representative.
"CLAIMS" has the meaning set forth in Section 6.1(a) hereof.
"COMBIPATCH PRODUCT" means the transdermal estrogen/progestin product
which has been developed by Noven, solely or jointly with Aventis or its
Affiliates, and is marketed and sold by Vivelle under the trademark
CombiPatch(TM) in the United States.
"CONFIDENTIAL INFORMATION" means all proprietary data, know-how and
related information, including all regulatory approvals and related filings,
applications and data, the content of any unpublished patent applications,
operating methods and procedures, marketing, distribution and sales methods and
systems, sales figures and other business information.
"DEVELOPMENT PLAN" shall mean a program described in Exhibit B attached
hereto, or as subsequently amended or modified by mutual agreement between
Novartis and Noven, and any subsequent extension of any such program.
"DEVELOPMENT PRODUCT" shall mean a Licensed Product described in
Exhibit A attached hereto, which Exhibit A shall be amended or supplemented from
time to time by mutual agreement between Novartis and Noven, as additional
Licensed Products are added to this Agreement.
"DEVELOPMENT TEAM" has the meaning set forth in Section 3.1 hereof.
"DISCLOSING PARTY" has the meaning set forth in Section 5.1(a) hereof.
"ESTALIS PRODUCT" means the product which is the Licensed Product as
defined in the Existing Novartis Pharma Sublicense Agreement.
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"FDA ACT" means the United States Federal Food, Drug and Cosmetic Act,
as amended, and the regulations promulgated thereunder, as amended from time to
time.
"GLP" means the Current Good Laboratory Practices as that term is
defined by the FDA which are in force or hereafter adopted by the FDA in its
applicable regulations promulgated or issued under the FDA Act, as amended from
time to time.
"GMP" means the Current Good Manufacturing Practices as that term is
defined by the FDA which are in force or hereafter adopted by the FDA in its
applicable regulations promulgated or issued under the FDA Act, as amended from
time to time.
"IND" means an Investigational New Drug Application as defined in the
FDA Act, or an equivalent application in another country or group of countries.
"LICENSED PRODUCT" means any Combination Product (as defined in the
Noven License Agreement) to which Novartis has any rights in the Territory under
the Noven License Agreement as amended other than the Estalis Product,
including, without limitation, any improvements or modifications, or proposed
improvements or modifications, to the CombiPatch Product or the Estalis Product.
"LOSSES" has the meaning set forth in Section 6.1(a) hereof.
"NDA" means a New Drug Application as defined in the FDA Act, or an
equivalent application for Regulatory Approval in another country or group of
countries.
"NOVARTIS INDEMNITEES" has the meaning set forth in Section 6.1(b)
hereof.
"NOVEN INDEMNITEES" has the meaning set forth in Section 6.1(c) hereof.
"NOVEN'S COSTS" shall mean the fully allocated costs including but not
limited to the fully allocated cost of goods and services and manufacturing
overhead directly related to the applicable Licensed Product, and an allocation
of all administrative and general expenses of Noven directly related to the
applicable Licensed Product. Noven's Costs shall be determined by generally
accepted accounting principles, applied on a consistent basis.
"PERSON" means any corporation, partnership, joint venture, other
entity or natural person.
"RECEIVING PARTY" has the meaning set forth in Section 5.1(a) hereof.
"REGULATORY APPROVAL" means filing for and receipt of all governmental
and regulatory registrations and approvals (including, but not limited to,
approvals of all final labeling and pricing approvals of any Licensed Product)
required for the marketing and sale of any Licensed Product in the Territory.
"REGULATORY AUTHORITY" means the U.S. Food and Drug Administration, and
any equivalent regulatory agency in any country in the Territory.
"RELATED AGREEMENTS" means the Improvements Sublicense Agreement, the
Noven License Agreement and the Purchaser Improvements Letter Agreement.
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"TERRITORY" means the world, except Japan.
"UNITED STATES" means the United States, its territories and
possessions.
"VIVELLE" means Vivelle Ventures LLC, a Delaware limited liability
company and joint venture owned by Noven and Novartis Pharmaceuticals
Corporation.
1.2. All capitalized terms used herein and not defined herein shall
have the meanings given to such terms in the Improvements Sublicense Agreement.
ARTICLE II
DEVELOPMENT
2.1. MASTER AGREEMENT.
(a) This Agreement shall serve as the master agreement under
which Novartis and Noven will develop Development Products under Development
Plans. Licensed Products to be developed hereunder shall be included in this
Agreement by mutual agreement of the Parties, evidenced by the addition of such
Development Products and Development Plans to Exhibits A and B hereto. No
Development Product or Development Plan shall be deemed to be effective or
accepted by either Party unless it has been signed by an Authorized
Representative of each Party.
(b) Subject to the terms and conditions of this Agreement,
Novartis hereby requests that Noven develop, and Noven agrees to develop, the
Development Products for chemical, toxicological, analytical, preclinical and
clinical testing by Novartis, which shall, for each Development Product, meet
the specifications described on Exhibit A attached hereto and made a part
hereof.
2.2. NOVEN OBLIGATIONS.
(a) Noven shall use commercially reasonable efforts, to
perform the activities designated as Noven activities in each Development Plan
within the time period set forth in such Development Plan.
(b) Noven shall supply Novartis in a timely manner with all
information in Noven's possession that is reasonably required by Novartis to
complete and file an IND with any Regulatory Authority and to complete and file
an NDA with any Regulatory Authority with respect to any Development Product.
(c) Noven shall comply with all applicable federal, state and
local laws, rules and regulations, including GLPs and GMPs, relating to Noven's
activities to be performed hereunder.
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2.3. NOVARTIS OBLIGATIONS.
(a) Novartis shall use commercially reasonable efforts to
perform such activities designated as Novartis activities in each Development
Plan within the time periods, specifically set forth therefor in such
Development Plan.
(b) Novartis shall supply Noven in a timely manner with all
information in Novartis' possession that is reasonably required by Noven to
perform its obligations hereunder with respect to any Development Product.
(c) Novartis shall comply with all applicable federal, state
and local laws, rules and regulations, including GLPs and GMPs, relating to
Novartis' activities to be performed hereunder.
2.4. MODIFICATION AND TERMINATION OF DEVELOPMENT PLAN. The parties
understand that product development is a dynamic process that may require
modifications from time to time. Since it is the desire and intention of the
Parties to review development plans and goals, the parties may, by mutual
agreement and acting through the Development Team, from time to time modify or
amend the specifications for a Development Product or a Development Plan,
described in Exhibits A and B, respectively, as circumstances and developments
warrant. Novartis may also at any time terminate individual Development Plans
without cause upon thirty (30) days prior written notice to Noven.
2.5. INITIAL REVIEW. At such time that Noven has developed a
Development Product for initial review which Noven reasonably believes meets the
requirements described in Exhibit A, Noven shall so notify Novartis and provide
Novartis with access to data, raw data and a supply of the Development Product
as set forth in Exhibit B for Novartis to perform, at its own expense, such
confirming tests that Novartis may desire to perform. Novartis shall notify
Noven as soon as reasonably practicable whether the Development Product meets
the requirements described in Exhibit A. In the event that such tests fail to
confirm that the Development Product meets the requirements described in Exhibit
A, then the Development Team shall convene a meeting to discuss the applicable
Development Plan, any required modifications to the Development Plan and any
additional costs that may be incurred by Noven in continuing to develop the
Development Product.
2.6. NO WARRANTY OF SUCCESS. Noven expressly disclaims any warranty
that any Development Product will be developed successfully or that any
Development Plan will be completed successfully. Novartis expressly acknowledges
that product development is inherently risky and that, notwithstanding Noven's
commercially reasonable efforts to develop any Development Product to meet
Novartis' specifications, such development may not be successful. Novartis
further acknowledges and agrees that its sole remedy in the event a Development
Product is not developed successfully by Noven in accordance with Article 2.2 is
to terminate the Development Plan with respect to such Development Product.
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ARTICLE III
DEVELOPMENT TEAM
3.1. ESTABLISHMENT AND PURPOSE. Each party will designate a number of
employees who will collectively constitute the "Development Team" for each
Development Product. The Development Team will work together in good faith to
agree on a Development Plan for each Development Product that will permit
Novartis to complete development of each Development Product pursuant to the
terms of this Agreement and secure Regulatory Approval for each Development
Product. Each Development Plan will set forth a proposed schedule for the
completion of the various aspects of the technical development work required for
each Development Product and for the filing of regulatory approval applications.
3.2. MEETINGS OF THE DEVELOPMENT TEAM. Unless otherwise agreed by the
Parties, the Development Team shall hold meetings at least twice each year with
the meeting site alternating between Novartis' headquarters and Noven's
headquarters. Meetings can be held by tele- or videoconference. Meetings shall
be co-chaired by the chief representatives of the Parties. At and between
meetings of the Development Team, each Party shall keep the other fully and
regularly informed as to its progress with its respective obligations. The
Development Team shall also monitor the progress of the Development Plan against
agreed milestones and shall report on delays in the conduct of the Development
Plan which would materially affect Noven's ability to achieve such milestones
and/or to timely and/or successfully complete the Development Plan within the
agreed time schedules, and shall recommend whether corrective action is
required.
3.3. DISPUTE RESOLUTION. In the event of any dispute between the
parties as to any matter involving a Development Plan, the Parties shall first
refer such dispute to the full Development Team for resolution. In the event the
Development Team is unable to resolve the dispute after diligent effort within
thirty (30) days, the matter shall then be resolved pursuant to the dispute
resolution procedure set forth in Article 9.1.
3.4 QUARTERLY REPORTING. Noven shall provide quarterly reports to
Novartis on the progress of the Development Plan. Wherever practicable such
quarterly reports shall be submitted before a meeting of the Development Team
takes place. Noven shall promptly notify the Novartis chief representative of
the Development Team in the event Noven recognises stability or other problems
arising out of the Development Plan that it considers will have a material
effect on the progress and/or likelihood of success of the Development Plan.
3.5 ISSUANCE OF FINAL REPORT. Within thirty (30) days after the
completion of a Development Plan, Noven shall submit to Novartis a draft final
report setting forth the results of the Development Plan. Novartis shall have
sixty (60) days within which to submit a written request for reasonable changes
to be made to the draft report or require the Development Plan to be amended to
allow for additional and reasonable development work to be conducted by the
Parties. Within thirty (30) days of receiving Novartis' request for changes or
after such additional development work has been conducted Noven shall prepare
and deliver to Novartis a final report which shall take into account the changes
requested by Novartis.
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ARTICLE IV
COMPENSATION
4.1 COST FOR DEVELOPMENT. For each Development Product, Novartis shall
pay to Noven the amounts set forth in the applicable Development Plan, such
amounts to be payable at the times set forth in such Development Plan. To the
extent any change is made in a Development Plan or in the specifications for a
Development Product requested by Novartis, the Parties shall mutually agree to
the amount of any incremental fees to be payable to Noven for such additional
work, and Noven shall not be required to commence any additional work until such
fee is agreed upon. Such agreement shall be reflected in an amendment to the
applicable Development Plan. All amounts payable by Novartis under a Development
Plan shall be non-refundable.
ARTICLE V
OWNERSHIP OF INTELLECTUAL PROPERTY RIGHTS
5.1 For the avoidance of doubt, the Parties acknowledge that, unless
otherwise expressly and specifically set forth herein, any Noven Patent Rights
and/or Noven Technology (as each such term is defined in the Noven License
Agreement) arising out of this Development Agreement are part of the Sublicensed
Noven Intellectual Property (as defined in the Improvements Sublicense
Agreement) and as such are governed by the Improvements Sublicense Agreement and
are included in the sublicense grant to Novartis thereunder.
ARTICLE VI
CONFIDENTIALITY
6.1 CONFIDENTIALITY; PRESS RELEASES.
(a) Pursuant to the terms hereof, from time to time during the
term of this Agreement, each of Novartis and Noven and/or their respective
Affiliates and sublicensees (in such capacity, the "Disclosing Party") have
disclosed and will be disclosing to the other Party and/or its Affiliates (in
such capacity, the "Receiving Party") certain Confidential Information of the
Disclosing Party. The Receiving Party shall make no use of such Confidential
Information except in the exercise of its rights and performance of its
obligations set forth in this Agreement and the Related Agreements. The
Receiving Party shall use the same efforts to keep secret, and prevent the
disclosure to third parties of, Confidential Information of the Disclosing Party
as it would use with respect to its own Confidential Information. Confidential
Information disclosed by the Disclosing Party shall remain the sole and absolute
property of the Disclosing Party, subject to the rights granted in this
Agreement and the transactions contemplated herein. The above restrictions on
the use and disclosure of Confidential Information shall not apply to any
information which: (i) is already known to the Receiving Party at the time of
disclosure by the Disclosing Party, as demonstrated by competent proof; (ii) is
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or becomes generally available to the public other than through any act or
omission of the Receiving Party in breach of this Agreement; (iii) is acquired
by the Receiving Party from a third party who is not, directly or indirectly,
under an obligation of confidentiality to the Disclosing Party with respect to
same; or (iv) is developed independently by the Receiving Party without use,
direct or indirect, of information that is required to be held confidential
hereunder.
In the event the Receiving Party is required: (i) by law, rule
or regulation to disclose Confidential Information of the Disclosing Party to
regulatory authorities to obtain and maintain regulatory approval for any
Licensed Product; (ii) to disclose Confidential Information of the Disclosing
Party to respond to a regulatory or governmental inquiry concerning any Licensed
Product; or (iii) to disclose Confidential Information of the Disclosing Party
in a judicial, administrative or arbitration proceeding to enforce such Party's
rights under this Agreement, it may do so only if it: (A) provides the
Disclosing Party with as much advance written notice as possible of the required
disclosure; (B) cooperates with the Disclosing Party in any attempt to prevent
or limit the disclosure; and (C) limits disclosure, if any, to the specific
purpose at issue.
(b) Notwithstanding the provisions of this Section 6.1,
Novartis, its Affiliates and sublicensees, shall be permitted to disclose to
their respective distributors, wholesalers and other direct customers such
Confidential Information relating to Development Products as Novartis, its
Affiliates and sublicensees, shall reasonably determine to be necessary or
useful in order to effectively market and distribute any Development Product;
provided that such entities undertake substantially the same confidentiality
obligation as Novartis has with respect to Noven's Confidential Information.
(c) Except as may be required by applicable laws, rules or
regulations, including stock exchange rules, no Party will originate any
publicity, press or news release, or other public announcement, written or oral,
whether to the public press or otherwise, relating to this Agreement or the
Related Agreements, the transactions contemplated hereby or thereby, without the
prior written approval of the other Party. In the event disclosure of this
Agreement or any of the Related Agreements, any of the terms and conditions of
this Agreement or such Related Agreements, or any of the transactions
contemplated by this Agreement or such Related Agreements, is required by
applicable law, rules or regulations, then the Party required to so disclose
such information shall, to the extent possible, provide to the other Party for
its prior approval (such approval not to be unreasonably withheld or delayed) a
written copy of such public announcement. When practicable, the disclosing Party
will provide such copy to the other Party at least five (5) business days prior
to disclosure.
(d) Neither Party shall use the name of the other for
marketing, advertising or promotional claims without the prior written consent
of the other Party.
6.2. INJUNCTIVE RELIEF. Each of Noven and Novartis specifically
recognizes that any breach by it of Section 5.1 may cause irreparable injury to
the other Party, its Affiliates and sublicensees and that actual damages may be
difficult to ascertain, and, in any event, may be inadequate. Accordingly (and
without limiting the availability of legal or equitable, including injunctive,
remedies under any other provisions of this Agreement), each of Noven and
Novartis agrees that in the event of any such breach, notwithstanding the
provisions of Section 8.1, the other Party shall be entitled to seek, by way of
private litigation in the first instance, injunctive relief and such other legal
and equitable remedies as may be available.
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ARTICLE VII
INDEMNIFICATION
7.1. INDEMNIFICATION. In order to distribute among themselves the
responsibility for claims arising out of this Agreement, and except as otherwise
specifically provided for herein, the Parties agree as follows:
(a) Novartis shall defend, indemnify and hold Noven, its
Affiliates, and each of their respective officers, directors, agents, employees
and shareholders (collectively, "NOVEN INDEMNITEES") harmless, from and against,
any and all losses, obligations, liabilities, penalties and damages (including
but not limited to compensatory damages), costs and expenses (including
reasonable attorneys' fees) (collectively, "LOSSES"), which the Noven
Indemnitees may incur or suffer, and all deficiencies, actions (including,
without limitation, any proceedings to establish insurance coverage), claims,
suits, legal, administrative, arbitration, governmental or other proceedings or
investigations, and judgments (collectively, "CLAIMS"), with which any of them
may be faced arising out of: (i) any material inaccuracy in or material breach
of any representation and warranty made by Novartis in this Agreement; (ii) any
material breach by Novartis or any of its Affiliates or sublicensees, or
material failure by any of them to comply with, any covenants or obligations of
Novartis pursuant to this Agreement; (iii) the enforcement by the Noven
Indemnitees of their rights under this Section 6.1(a); (iv) any gross negligence
or willful misconduct by Novartis or its Affiliates in Novartis' performance
pursuant to this Agreement; and (v) Novartis' material violation of any
applicable law or regulation; provided, however, that Novartis shall not be
liable hereunder to the extent such Losses arise from willful misconduct or
gross negligence of the Noven Indemnitees.
(b) Noven shall defend, indemnify and hold Novartis, its
Affiliates and sublicensees, and each of their respective officers, directors,
agents, employees and shareholders (collectively, "NOVARTIS INDEMNITEES")
harmless, from and against, any and all Losses, which the Novartis Indemnitees
may incur or suffer, and all Claims with which any of them may be faced arising
out of (i) any material inaccuracy in or material breach of any representation
and warranty made by Noven in this Agreement; (ii) any material breach by Noven
of, or material failure by Noven to comply with, any of its covenants or
obligations pursuant to this Agreement; (iii) the enforcement by the Novartis
Indemnitees of their rights under this Section 6.1(b); (iv) any gross negligence
or willful misconduct by Noven or any of its Affiliates or sublicensees in their
performance pursuant to this Agreement; and (v) Noven's material violation of
any law or regulation; PROVIDED, HOWEVER, that Noven shall not be liable
hereunder to the extent such Losses arise from willful misconduct or gross
negligence of the Novartis Indemnitees.
(c) If any Claim arises as to which a right of indemnification
provided in this Article VI applies, the Person seeking indemnification (the
"indemnified party"), shall promptly notify the Party obligated under this
Article VI to indemnify the indemnified party (the "indemnifying party") thereof
in writing, and allow the indemnifying party and its insurers the opportunity to
assume direction and control of the defense against such Claim, at its sole
expense, including, without limitation, the settlement thereof at the sole
option of the indemnifying party or its insurers; PROVIDED, HOWEVER, that the
indemnifying party may not enter into any compromise or settlement without the
prior written consent of the indemnified party unless such compromise or
settlement includes as an unconditional term thereof the giving by each
plaintiff or claimant to the indemnified party of a release from all liability
in respect of such claim and only if such compromise or settlement does not
include any admission of legal wrongdoing on the part of the indemnified party.
The indemnified party shall fully cooperate with the indemnifying party and its
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insurer in the disposition of any such matter and the indemnified party will
have the right and option to participate in (but not control) the defense of any
Claim as to which this Article VI applies, with separate counsel at its election
and cost. If the indemnifying party fails or declines to assume the defense of
any such Claim within thirty (30) days after notice thereof, the indemnified
party may assume the defense thereof for the account and at the risk of the
indemnifying party. The indemnifying party shall pay promptly to the indemnified
party any Losses to which the indemnity under this Article VI applies, as
incurred.
ARTICLE VIII
TERM AND TERMINATION; REMEDIES
8.1. TERM. The term of this Agreement shall commence on the date hereof
and shall expire, unless sooner terminated as set forth herein, upon the
expiration or termination of the licenses sublicensed by Novartis under the
Improvements Sublicense Agreement.
8.2. TERMINATION FOR BANKRUPTCY. Either of Noven or Novartis may
terminate this Agreement with immediate effect in the event that any proceeding
under a bankruptcy, liquidation or similar statute, or any insolvency,
receivership or dissolution proceeding is filed against the other Party, and
such proceeding is not dismissed within sixty (60) days after the filing
thereof.
8.3. TERMINATION FOR BREACH. If either of Novartis or Noven commits a
material breach of this Agreement, or materially defaults in the performance or
observance of any provision of this Agreement, and (i) such Party fails, within
sixty (60) days after receipt of notice of the material breach from the Party
affected by the breach or default (the "AFFECTED PARTY"), to remedy such breach
or default or to have agreed to a plan for remedy of such breach or default and
(ii) the Parties shall have exhausted the dispute resolution procedures provided
in Article 8.1 without resolving their dispute regarding the material breach;
PROVIDED that the time periods contemplated by the foregoing clauses (i) and
(ii) may run concurrently and need not be sequential, the Affected Party may
terminate this Agreement.
8.4. EFFECT OF TERMINATION. Rights and obligations set forth in
Sections 5.1 (Confidentiality; Press Releases), 6.1 (Indemnification) and
Article VIII (Miscellaneous) shall survive the termination of this Agreement,
and otherwise, except as set forth in this Section 7.4, this Agreement shall
become void and have no effect.
8.5. FORCE MAJEURE. The obligations of the Parties under this Agreement
shall be subject to any delays or non-performance caused by: acts of God,
earthquakes, fires or floods; explosions, sabotage, riots or accidents;
regulatory, governmental or military action or inaction; strikes, lockouts or
labor trouble; perils of the sea; failure or delay in performance by third
parties, including suppliers and service providers; or any other cause beyond
the reasonable control of either Party. The Party which is not performing its
obligations under this Agreement as a result of any such event of force majeure
will promptly notify the other Party thereof and shall use commercially
reasonable efforts to resume compliance with this Agreement as soon as possible.
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ARTICLE IX
MISCELLANEOUS
9.1. DISPUTES. In the event of any controversy or claim arising out of,
relating to or in connection with any provision of this Agreement, the
Improvements Sublicense Agreement or the Noven License Agreement, or the rights
or obligations of the Parties hereunder or thereunder, the Parties shall try to
settle their differences amicably between themselves. Either Party may initiate
such informal dispute resolution by sending written notice of the dispute to the
other Party, and within ten (10) days after such notice appropriate
representatives of the Parties shall meet for attempted resolution by good faith
negotiations. If such representatives are unable to resolve promptly such
disputed matter, it shall be referred to the Head of Development of Novartis
Pharma AG and the Chief Executive Officer of Noven, as the case may be, or their
respective designees, for discussion and resolution. If such personnel are
unable to resolve such dispute within thirty (30) days of initiating such
negotiations, the Parties agree first to try in good faith to settle the dispute
by mediation in New York under the Commercial Mediation Rules of the American
Arbitration Association, before resorting to litigation.
9.2. INDEPENDENT CONTRACTORS. In making and performing this Agreement,
the Parties are acting and shall act as independent contractors. Nothing in this
Agreement shall be deemed to create an agency, joint venture or partnership
relationship between the Parties hereto. Neither Party shall have the authority
to obligate the other Party in any respect, and neither Party shall hold itself
out as having any such authority. All personnel of Noven shall be solely
employees of Noven, as applicable and shall not represent themselves as
employees of Novartis. All personnel of Novartis shall be solely employees of
Novartis, as applicable and shall not represent themselves as employees of
Noven.
9.3. ASSIGNMENT. Neither Noven nor Novartis shall have a right to
assign this Agreement without the prior written consent of the other (which
consent shall not be unreasonably withheld or delayed); PROVIDED, HOWEVER, that
each of Noven and Novartis may assign this Agreement to any of its Affiliates
without the prior written consent of the other; PROVIDED, FURTHER, that no such
assignment of this Agreement shall relieve the assignor of any of its
obligations or liabilities under this Agreement. Notwithstanding the foregoing,
each of Noven and Novartis may assign this Agreement without the other's prior
written consent in connection with the transfer or sale of all or substantially
all of its assets or business or its merger or consolidation with another
Person.
9.4. BINDING EFFECT; BENEFIT. This Agreement shall inure to the benefit
of and be binding upon the Parties hereto, and their respective successors and
permitted assigns. Nothing contained herein shall give to any other Person,
other than Noven, any benefit or any legal or equitable right, remedy or claim.
9.5. AMENDMENT. This Agreement may only be modified, amended or
supplemented by an instrument in writing executed by Noven and Novartis.
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9.6. NO WAIVER. No term or provision hereof will be considered waived
by any Party, and no breach excused by any Party, unless such waiver or consent
is in writing signed on behalf of the Party against whom the waiver is asserted.
No consent by any Party to, or waiver of, a breach by any Party, whether express
or implied, will constitute a consent to, waiver of, or excuse of any other,
different or subsequent breach by any other Party.
9.7. NOTICES. All notices, claims, certificates, requests, demands and
other communications hereunder shall be in writing and shall be delivered
personally or sent by facsimile transmission, air courier, or registered or
certified mail, return receipt requested, addressed as follows:
If to Novartis:
Novartis Pharma AG
Xxxxxxxxxxxx 00
XX-0000 Xxxxx, Xxxxxxxxxxx
Fax: xx00 00 000 0000
Attn: General Counsel
With copies to:
Novartis Pharma AG
Xxxxxxxxxxxx 00
XX-0000 Xxxxx, Xxxxxxxxxxx
Fax: xx00 00 000 0000
Attn: Head BD & L
If to Noven:
Noven Pharmaceuticals, Inc.
00000 X.X. 000xx Xxxxxx
Xxxxx, Xxxxxxx 00000
Fax: (000) 000-0000
Attn: Chief Executive Officer
cc: General Counsel
or to such other address as the Party to whom notice is to be given may have
furnished to the other Parties in writing in accordance herewith. Any such
communication shall be deemed to have been delivered (a) when delivered, if
delivered personally, (b) when sent (with written confirmation received), if
sent by facsimile transmission on a business day, (c) on the first business day
after dispatch (with written confirmation received), if sent by facsimile
transmission on a day other than a business day, (d) on the second business day
after dispatch, if sent by air courier, and (e) on the fifth business day after
mailing, if sent by mail.
9.8. COUNTERPARTS. This Agreement shall become binding when any one or
more counterparts hereof, individually or taken together, shall bear the
signatures of each of the Parties hereto. This Agreement may be executed in any
number of counterparts, each of which shall be deemed an original as against the
Person whose signature appears thereon, but all of which taken together shall
constitute but one and the same instrument. Each Party may execute this
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Agreement on a facsimile of the Agreement. In addition, facsimile signatures of
authorized signatories of any Party shall be valid and binding and delivery of a
facsimile signature by any Party shall constitute due execution and delivery of
this Agreement.
9.9. INTERPRETATION. The article and section headings contained in this
Agreement are for reference purposes only and shall not affect in any way the
meaning or interpretation of this Agreement. This Agreement is the product of
negotiations between the Parties. In construing the terms hereof, no presumption
shall operate in any Party's favor as a result of its counsel's role in drafting
the terms or provisions hereof.
9.10. GOVERNING LAW. This Agreement and any claims, disputes or causes
of action relating to or arising out of this Agreement shall be construed in
accordance with and governed by the substantive laws of the State of New York,
U.S.A. without giving effect to the conflict of laws principles thereof.
9.11. SEVERABILITY. If any provisions of this Agreement are determined
to be invalid or unenforceable in any jurisdiction, such provisions shall be
ineffective to the extent of such invalidity or unenforceability in such
jurisdiction, without rendering invalid or unenforceable the remaining
provisions hereof or affecting the validity or enforceability of any of such
provisions of this Agreement in any other jurisdiction. The Parties will use
their best efforts to substitute the invalid or unenforceable provision with a
valid and enforceable one which conforms, as nearly as possible, with the
original intent of the Parties.
9.12. ENTIRE AGREEMENT. This Agreement, including all exhibits and
schedules and the Related Agreements, the Existing Novartis Pharma Sublicense
Agreement and the Purchaser Sublicense Letter Agreement, embody the entire
agreement and understanding between the Parties hereto with respect to the
subject matter hereof and supersede all prior agreements, commitments,
arrangements, negotiations or understandings, whether oral or written, between
the Parties hereto and their respective Affiliates with respect thereto. There
are no agreements, covenants or undertakings with respect to the subject matter
of this Agreement and the Related Agreements other than those expressly set
forth or referred to herein or in such other agreements, and no representations
or warranties of any kind or nature whatsoever, express or implied, are made or
shall be deemed to be made herein by the Parties hereto except those expressly
made in this Agreement and the Related Agreements.
9.13 FURTHER ASSURANCES. Each Party agrees to execute, acknowledge and
deliver such further instruments, and to do all such other acts, as may be
reasonably necessary or appropriate in order to carry out the purposes and
intent of this Agreement.
9.14 INCONSISTENCY. In the event of any inconsistency between the terms
of this Agreement and the Improvements Sublicense Agreement, the terms of this
Agreement shall prevail.
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IN WITNESS WHEREOF, the Parties hereto have executed this Development
Agreement as of date first above written.
NOVARTIS PHARMA AG
By: /s/ J. Brokatzky-Xxxxxx
---------------------------------------------
Name: J. Brokatzky-Xxxxxx
Title: Head of Worldwide Technical R&D
By: /s/ X. Xxxxxxxxx
---------------------------------------------
Name: Xxxxx Xxxxxxxxx
Title: Global Head Pharma Development
NOVEN PHARMACEUTICALS, INC.
By: /s/ Xxxxx X. Xxxxxxx
---------------------------------------------
Name: Xxxxx X. Xxxxxxx
Title: Vice President and Chief
Financial Officer
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