1
EXHIBIT 10.3
SUBLICENSE AGREEMENT
among
XXXXX PHARMACEUTICAL PRODUCTS, INC.,
XXXXX-XXXXXXX XXXXX INC.,
AVENTIS PHARMACEUTICALS PRODUCTS INC.
XXXXX-XXXXXXX XXXXX INTERNATIONAL HOLDINGS INC.
and
NOVARTIS PHARMA AG
and
NOVEN PHARMACEUTICALS, INC.
MARCH 29, 2001
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
TABLE OF CONTENTS
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ARTICLE I DEFINITIONS.................................................................................2
1.1. Definitions.................................................................................2
1.2. Product Formulated as of the Date Hereof....................................................5
ARTICLE II SUBLICENSE GRANT............................................................................5
2.1. Sublicense to Sublicensed Noven Intellectual Property.......................................5
2.2. Assumption of Obligations...................................................................6
2.3. Retention of Rights.........................................................................6
2.4. Right to Sublicense.........................................................................6
2.5. ***.........................................................................................6
2.6. ***.........................................................................................7
2.7. ***.........................................................................................7
ARTICLE III CONSIDERATION...............................................................................7
3.1. ***.........................................................................................7
3.2. Payment of Noven's Patent Costs.............................................................7
ARTICLE IV RIGHT OF REFERENCE..........................................................................7
4.1. ***.........................................................................................7
4.2. ***.........................................................................................7
4.3. ***.........................................................................................7
ARTICLE V TRADEMARKS AND DOMAIN NAMES.................................................................8
5.1. ***.........................................................................................8
5.2. ***.........................................................................................8
5.3. ***.........................................................................................8
5.4. ***.........................................................................................8
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
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ARTICLE VI INTELLECTUAL PROPERTY CLAIMS................................................................8
6.1. Infringement or Other Actions Regarding the Assigned Licensed Product Know-How..............8
6.2. Infringement or Other Actions Regarding Intellectual Property Rights........................8
6.3. ***.........................................................................................9
6.4. ***.........................................................................................9
6.5. Other Third Party Claims....................................................................9
ARTICLE VII CONFIDENTIALITY AND NONCOMPETITION..........................................................9
7.1. Confidentiality; Press Releases.............................................................9
7.2. ***........................................................................................11
7.3. ***........................................................................................11
7.4. ***........................................................................................11
7.5. Noncompetition by Noven....................................................................11
ARTICLE VIII INDEMNIFICATION............................................................................11
8.1. Indemnification............................................................................11
ARTICLE IX TERM AND TERMINATION; REMEDIES.............................................................13
9.1. Term.......................................................................................13
9.2. Termination for Bankruptcy.................................................................13
9.3. Noven Termination Right....................................................................13
9.4. Remedies for Breach........................................................................14
9.5. Effect of Termination......................................................................15
9.6. ***........................................................................................15
9.7. Remedies Reasonable........................................................................15
9.8. No Penalties...............................................................................15
9.9. Force Majeure..............................................................................15
ARTICLE X CERTAIN ADDITIONAL COVENANTS,
REPRESENTATIONS AND AGREEMENTS.............................................................16
10.1. ***........................................................................................16
10.2. ***........................................................................................16
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Securities and Exchange Commission. Asterisks denote omissions.
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ARTICLE XI MISCELLANEOUS..............................................................................16
11.1. Disputes...................................................................................16
11.2. Independent Contractors....................................................................16
11.3. Assignment.................................................................................16
11.4. Binding Effect; Benefit....................................................................17
11.5. Amendment..................................................................................17
11.6. No Waiver..................................................................................17
11.7. Notices....................................................................................17
11.8. Counterparts...............................................................................18
11.9. Interpretation.............................................................................18
11.10. Governing Law..............................................................................19
11.11. Severability...............................................................................19
11.12. Entire Agreement...........................................................................19
11.13. Further Assurances.........................................................................19
11.14. Inconsistency..............................................................................19
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
SUBLICENSE AGREEMENT
THIS SUBLICENSE AGREEMENT (this "AGREEMENT"), dated as of March 29, 2001, is by
and among XXXXX PHARMACEUTICAL PRODUCTS, INC, a Delaware corporation with its
principal office at 0000 Xxxxxxx Xxxx, Xxxxx 000, Xxxxxxxxxx, Xxxxxxxx X.X.X.
00000 (hereinafter referred to as "AVENTIS"), XXXXX-XXXXXXX XXXXX INC., a
Pennsylvania corporation with its principal office at Xxxxx 000-000,
Xxxxxxxxxxx, Xxx Xxxxxx, 00000 ("RPR"), AVENTIS PHARMACEUTICALS PRODUCTS INC., a
Delaware corporation with its principal office at Xxxxx 000-000, Xxxxxxxxxxx,
Xxx Xxxxxx , 00000 ("APPI"), Xxxxx-Xxxxxxx Xxxxx International Holdings Inc., a
Delaware corporation with its principal office at 0000 Xxxxxxx Xxxx, Xxxxx 000,
Xxxxxxxxxx, Xxxxxxxx X.X.X. 00000 ("RPRIH") and 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"). For purposes of this
Agreement, each of Aventis, RPR, APPI, RPRIH and Novartis are a "PARTY" to this
Agreement, and collectively Aventis, RPR, APPI, RPRIH and Novartis are the
"PARTIES" to this Agreement. Noven is a Party to this Agreement solely with
respect to the following applicable provisions of the Agreement: Section 2.1
(Sublicense to the Sublicensed Noven Intellectual Property); Section 2.2
(Assumption of Obligations); Section 2.3 (Retention of Rights); Section 2.4
(Right to Sublicense); Section 3.2 (Payment of Noven's Patent Costs); Sections
6.1, 6.2 and 6.5 (Infringement and Other Third Party Claims); Section 7.2(e)
(Noncompetition); Section 7.5 (Noncompetition by Noven); Article VIII
(Indemnification); Sections 9.1, 9.2, 9.3, 9.4, 9.5, 9.7, 9.8 and 9.9 (relating
generally to Term, Termination, Remedies and Penalties) and Article XI
(Miscellaneous).
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 the day before the
date hereof (collectively, the "NOVEN LICENSE AGREEMENT") attached hereto as
EXHIBIT A, 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 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
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
WHEREAS, the Parties and Noven desire to enter into a transaction
pursuant to which, among other things, (a) Aventis will grant to Novartis an
exclusive sublicense to develop, use, sell or otherwise dispose of any and all
Licensed Product; (b) APPI and RPRIH, and RPR, will assign and transfer to
Novartis the Trademarks and the Domain Names, respectively, (c) Aventis and
Novartis will agree, effective as of the date hereof, to revise and replace
certain rights and obligations under the Existing Novartis Pharma Sublicense
Agreement, and (d) Novartis and Noven will agree to revise and replace certain
rights and obligations under the Noven License Agreement, all on the terms and
conditions contained in this Agreement;
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 9.4 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.
"AMENDMENT AGREEMENT" means Amendment No. 2 to the Noven License
Agreement between Aventis and Noven executed prior to the Closing Date and
effective as of the day before the Closing Date.
***.
"AVENTIS INDEMNITEES" has the meaning set forth in Section 8.1(a)
hereof.
"CLAIMS" has the meaning set forth in Section 8.1(a) hereof.
"CLOSING DATE" has the meaning set forth in the Purchase Agreement.
"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 Aventis and its Affiliates under the
trademark CombiPatchTM in the United States as of the Closing Date, and which,
without limiting the foregoing, is sold, assigned and transferred to Vivelle
under the Vivelle License Agreement and the Purchase Agreement.
"COMPETING PRODUCT" means ***.
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
"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 and the Noven Confidential
Information disclosed to Aventis pursuant to the Noven License Agreement.
"CONSIDERATION" has the meaning set forth in Section 3.1 hereof.
"COURT" has the meaning set forth in Section 7.2(d) hereof.
"DISCLOSING PARTY" has the meaning set forth in Section 7.1(a) hereof.
***.
"ESTALIS(R)" has the meaning set forth in Section 5.3(a) hereof.
"ESTALIS PRODUCT" means the product which is the Licensed Product as
defined in the Existing Novartis Pharma Sublicense Agreement.
"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.
"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 Aventis 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 8.1(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 8.1(b)
hereof.
"NOVEN INDEMNITEES" has the meaning set forth in Section 8.1(c) hereof.
"OFFENDING PRODUCT" has the meaning set forth in Section 9.3(a).
"ONGOING OBLIGATIONS" has the meaning set forth in Section 9.6 hereof.
***.
"PERSON" means any corporation, partnership, joint venture, other
entity or natural person.
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
"PURCHASE AGREEMENT" means the Purchase Agreement between Aventis, APPI
and Vivelle dated on the date hereof.
"PURCHASER SUBLICENSE LETTER AGREEMENT" means the Letter Agreement
between, inter alia, Vivelle and Novartis dated March 29, 2001 pursuant to which
Novartis shall offer to sublicense to Vivelle all of its rights under this
Agreement in the United States on a product-by-product basis.
"RECEIVING PARTY" has the meaning set forth in Section 7.1(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
existing at the Closing Date.
***.
"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 Purchase Agreement, the Amendment
Agreement, the Purchaser Sublicense Letter Agreement and the Vivelle License
Agreement.
"SUBLICENSED NOVEN INTELLECTUAL PROPERTY" means Noven's Patent Rights
and Noven's Technology (as each such term is defined in the Noven License
Agreement) which are licensed to Aventis pursuant to the Noven License
Agreement. Noven's Patent Rights at the date hereof include, without limitation,
those patents and patent applications listed in SCHEDULE A attached hereto.
"TERRITORY" means worldwide, 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, which is the Purchaser under the Purchase Agreement.
"VIVELLE LICENSE AGREEMENT" means the License Agreement between Noven
and Vivelle dated on the Closing Date.
***.
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
1.2. PRODUCT FORMULATED AS OF THE DATE HEREOF. Wherever, in this
Agreement, reference is made to the Estalis Product or the CombiPatch Product
"formulated as of the date hereof", such expression may include different dosage
strengths of the Estalis Product or the CombiPatch Product, as the case may be.
To be considered Estalis Product or the CombiPatch Product "formulated as of the
date hereof", ***.
ARTICLE II
SUBLICENSE GRANT
2.1. SUBLICENSE TO SUBLICENSED NOVEN INTELLECTUAL PROPERTY.
(a) Subject to the terms and conditions of this Agreement,
with effect from the Closing Date, Aventis hereby grants to Novartis, and
Novartis hereby accepts, during the term of this Agreement, an exclusive (even
as to Aventis and its Affiliates) sublicense to all rights and benefits of
Aventis and its Affiliates arising out of or under the Noven License Agreement
in the Territory. For the avoidance of doubt, (i) the Parties acknowledge that
the Amendment Agreement is effective in all respects prior to the grant of the
sublicense granted hereunder; (ii) the foregoing sublicense includes, without
limitation, the right to make modifications and/or improvements to the
CombiPatch Product and to develop, use, sell or otherwise dispose of any such
modifications and/or improvements in the Territory, including, without
limitation, the United States (in each case insofar as such rights are granted
pursuant to the Noven License Agreement as modified hereby), but shall not
include the right to use, sell or otherwise dispose of the CombiPatch Product in
the United States; and (iii) the foregoing sublicense shall include any of
Noven's Patent Rights or Noven's Technology (each as defined in the Noven
License Agreement) which relate to any improvement or proposed improvement to
the CombiPatch Product or the Estalis Product including, without limitation, the
improvements or proposed improvements described in SCHEDULE 2.1(A).
(b) Novartis acknowledges and agrees that the sublicense
granted pursuant to Section 2.1(a) is and shall be subordinate to, and subject
to the terms and conditions of, the license granted to Aventis by Noven pursuant
to the Noven License Agreement except as otherwise provided herein. Without
limiting the foregoing, the Parties acknowledge that, pursuant to the Amendment
Agreement and this Agreement; (i) Aventis has no right to terminate the rights
under the Noven License Agreement in the Territory or the rights to the
sublicense granted hereunder, and (ii) Noven has no right to terminate the Noven
License Agreement in the Territory, but Noven shall, after the Closing Date,
have the right to terminate the sublicense granted hereunder, in which event
such termination shall operate as a termination of the Noven License Agreement
in the Territory by Noven under Sections 8.2(a), (b) or (d) of the Noven License
Agreement, and the Parties further agree that Novartis may enforce against Noven
directly the rights granted hereunder to Novartis pursuant to the Noven License
Agreement as amended hereby.
(c) Noven hereby consents to the grant under this Section 2.1
of the sublicense from Aventis to Novartis in consideration for Novartis
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Securities and Exchange Commission. Asterisks denote omissions.
assuming the obligations referenced in Section 2.2 and providing Noven a direct
means of enforcing such obligations against Novartis, in Articles VIII and IX.
2.2. ASSUMPTION OF OBLIGATIONS. As between Novartis, its Affiliates and
sublicensees on the one hand and Aventis, its Affiliates and sublicensees on the
other hand, Novartis will be solely responsible for, and hereby assumes,
following the Closing Date, those obligations under the Noven License Agreement
with respect to the development, use, sale or other disposal of Licensed Product
in the Territory, which are set forth in SCHEDULE 2.2 attached hereto; PROVIDED,
HOWEVER, that, (a) in each case, Novartis shall be responsible, and hereby
assumes, such obligations only to the extent that such obligations relate
directly to the development, use, sale or other disposal of Licensed Product in
the Territory, and only to the extent that they have not been modified herein;
(b) Novartis, its Affiliates and sublicensees, shall not be bound by any
Development Plan agreed between Noven and Aventis; and (c) Novartis, its
Affiliates and sublicensees, shall not be bound by the provisions of the Supply
Agreement which is incorporated into the Noven License Agreement. The Parties
agree that, pursuant to the Amendment Agreement, Noven has relieved Aventis, its
Affiliates and sublicensees from any financial and diligence obligations under
the Noven License Agreement with respect to the development, use, sale or other
disposal of Licensed Product in the Territory that are not assumed by Novartis
hereunder. Novartis, its Affiliates and sublicensees, will negotiate, agree and
enter into separate arrangements with Noven regarding their development
obligations under the Noven License Agreement. Supply of any Licensed Product to
Novartis, its Affiliates and sublicensees, shall be the subject of separate
arrangements with Noven. With effect from not later than the Closing Date,
Aventis hereby releases Noven from the obligations of Noven set forth in Article
5.4 of the Noven License Agreement. Further, Aventis undertakes that,
notwithstanding any failure by Aventis to renew the Supply Agreement which is
incorporated in the Noven License Agreement, the term of the Lease Agreement
with respect to the Facility (as defined in the Noven License Agreement) shall
not expire, and shall be automatically renewed on the same terms, for the term
of this Agreement. Noven hereby consents to the foregoing provisions, and agrees
to use commercially reasonable efforts to co-operate with Novartis, its
Affiliates and sublicensees in the development of Licensed Products.
2.3. RETENTION OF RIGHTS. Nothing in this Agreement as between Aventis
and Noven shall impair or limit the rights of Aventis under the Noven License
Agreement outside the Territory.
2.4. RIGHT TO SUBLICENSE. The Parties agree that this Agreement grants
to Novartis no right to grant any sublicense under the sublicense granted to
Novartis pursuant to Section 2.1 hereof without the consent of Noven as required
under Article 3.1(d) of the Noven License Agreement; PROVIDED, HOWEVER, that
Novartis shall have the right to grant further sublicenses under the sublicense
granted to Novartis pursuant to Section 2.1 hereof to Vivelle (and Persons
acting on behalf of Vivelle) without obtaining prior approval from Noven.
Affiliates, agents, distributors, wholesalers and other independent resellers
shall not be considered sublicensees hereunder. Noven hereby consents to the
foregoing provision.
2.5. ***.
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Securities and Exchange Commission. Asterisks denote omissions.
2.6. ***.
2.7. ***.
ARTICLE III
CONSIDERATION
3.1. ***.
3.2. PAYMENT OF NOVEN'S PATENT COSTS. Following the Closing Date
Novartis shall assume Aventis' obligation, set forth in Articles 6.1 and 6.2 of
the Noven License Agreement, to pay patent filing fees, costs and expenses
incurred on a country by country basis in the Territory with respect to any such
Licensed Product; PROVIDED, HOWEVER, that Novartis shall not be obliged to pay
any patent filing fees, costs or expenses incurred in any country where neither
Novartis nor Noven expects a Licensed Product covered by the claims of the
applicable patent to be marketed. The Parties and Noven agree that Novartis will
be entitled to the same offset rights set forth in Articles 6.1 and 6.2 of the
Noven License Agreement as would otherwise be available to Aventis under such
articles. Upon the first sale of a Licensed Product by Novartis or any of its
Affiliates or sublicensees in a country in the Territory, Novartis' obligation
under this Section 3.2 will be relieved for that country. On and after the
Closing Date, and to the extent duplicative, this Section 3.2 shall supersede
the obligation of Novartis set forth in Section 3.5 of the Existing Novartis
Pharma Sublicense Agreement for all such patent expenses incurred after the
Closing Date. Noven shall cooperate with Novartis in connection with Novartis'
obligations under this Section 3.2, by, but not limited to, providing the
necessary information to enable Novartis to come to an informed decision whether
to pay expenses and providing an annual budget of costs which shall be discussed
promptly should it be significantly exceeded. Pursuant to the Amendment
Agreement, Noven has relieved Aventis, its Affiliates and sublicensees of all
obligations set forth in Articles 6.1 and 6.2 of the Noven License Agreement in
the Territory not assumed by Novartis hereunder. Noven hereby consents to the
foregoing provisions.
ARTICLE IV
RIGHT OF REFERENCE
4.1. ***.
4.2. ***.
4.3. ***.
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
ARTICLE V
TRADEMARKS AND DOMAIN NAMES
5.1. ***.
5.2. ***.
5.3. ***.
5.4. ***.
ARTICLE VI
INTELLECTUAL PROPERTY CLAIMS
6.1. INFRINGEMENT OR OTHER ACTIONS REGARDING THE ASSIGNED LICENSED
PRODUCT KNOW-HOW.
(a) If any Party shall become aware of any infringement or
threatened infringement of the Assigned Licensed Product Know-How or any unfair
competition, disparagement or other tortious act by any third party in relation
to the Assigned Licensed Product Know-How, then the Party having such knowledge
shall give prompt notice thereof to the other Party.
(b) Novartis, its Affiliates and sublicensees, shall have the
right to take such action as it deems appropriate to protect and enforce the
Assigned Licensed Product Know-How in the Territory, including but not limited
to, bringing an action, suit or other appropriate proceeding to prevent or
eliminate the infringement of such Assigned Licensed Product Know-How, or the
unfair competition, disparagement or other tortious act by any third party in
relation to the Assigned Licensed Product Know-How in the Territory. Aventis and
Noven each agree to cooperate with Novartis in any reasonable manner requested
by Novartis in any such action, suit or proceeding, at the expense of Novartis,
its Affiliates or sublicensees, as appropriate, including, without limitation,
joining as a party to such action, suit or proceeding, if necessary to maintain
standing.
(c) All amounts awarded as damages, profits or otherwise in
connection with any action taken by Novartis, its Affiliates or licensees, shall
be ***. If Novartis, its Affiliates and licensees, elect not to take any action
of the nature specified in Section 6.1(b), Novartis shall give Aventis notice of
such decision, and Aventis thereafter shall have the right to take any action of
the nature specified in Section 6.1(b) with respect to the use of the Assigned
Licensed Product Know-How in the Territory. In such event, all amounts awarded
as damages, profits or otherwise in connection with any action taken by Aventis
shall be ***.
6.2. INFRINGEMENT OR OTHER ACTIONS REGARDING INTELLECTUAL PROPERTY
RIGHTS. (a) If any Party becomes aware of any infringement or threatened
infringement of (i) the Sublicensed Noven Intellectual Property or (ii) any
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other intellectual property rights of the parties to the Noven License Agreement
used in the development, manufacture or marketing of Licensed Product,
(including, without limitation, by the filing of any certification in the United
States claiming that any such intellectual property rights are invalid or will
not be infringed by the manufacture, use or sale of a product by a third party)
such Party shall provide notice to all interested parties in accordance with
Article 6.4 of the Noven License Agreement, and comply with the provisions of
Article 6.4 of the Noven License Agreement with respect to the determination of
whether to prosecute the alleged infringement.
(b) In the event Aventis is entitled to prosecute an infringement
action pursuant to Article 6.4 of the Noven License Agreement, Novartis hereby
assumes all such rights, and related obligations, after the Closing Date;
PROVIDED, HOWEVER, that (i) Aventis shall cooperate with and assist Novartis,
its Affiliates and sublicensees, in good faith with respect thereto; and (ii) in
the event Novartis, its Affiliates or sublicensees, brings any such action,
Noven shall, at the request of Novartis, provide Novartis, its Affiliates or
sublicensees, with reasonable assistance at the expense of Novartis, its
Affiliates or sublicensees, as appropriate, in accordance with Article 6.4 of
the Noven License Agreement.
(c) ***.
6.3. ***.
6.4. ***.
6.5. OTHER THIRD PARTY CLAIMS. If either Aventis or Noven becomes aware
of any action, suit or proceeding or threat of action, suit or proceeding, by a
third party alleging that the manufacture, use, import or sale of Licensed
Product in the Territory infringes or violates any other intellectual property
right of any third party, Aventis or Noven, as appropriate, shall promptly
notify Novartis of the same.
ARTICLE VII
CONFIDENTIALITY AND NONCOMPETITION
7.1. CONFIDENTIALITY; PRESS RELEASES.
(a) Pursuant to the terms hereof, from time to time during the
term of this Agreement, each of Novartis and Aventis 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
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Securities and Exchange Commission. Asterisks denote omissions.
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
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 7.1, but
still subject to compliance with the terms of the Noven License Agreement,
Novartis, its Affiliates and sublicensees, shall be permitted to disclose to
their respective distributors, wholesalers and other direct customers such
Confidential Information relating to Licensed Product or improvements thereto as
Novartis, its Affiliates and sublicensees, shall reasonably determine to be
necessary or useful in order to effectively market and distribute any Licensed
Product; provided that such entities undertake substantially the same
confidentiality obligation as Novartis has with respect to Aventis' Confidential
Information.
(c) ***
(d) Except as may be required by applicable laws, rules or
regulations, 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, or to the existence of an
arrangement between the Parties, 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.
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(e) Neither Party shall use the name of the other for
marketing, advertising or promotional claims without the prior written consent
of the other Party.
7.2. ***.
7.3. ***:
7.4. ***.
7.5. NONCOMPETITION BY NOVEN. (a) Noven covenants that for a period
beginning on the date hereof and ending ***, neither it nor any of its
Affiliates or sublicensees shall market, sell or distribute (or agree with any
third party to do any of the foregoing) any Competing Product in the Territory,
other than the Estalis Product, the CombiPatch Product and Licensed Product(s).
Notwithstanding the foregoing, with respect to the marketing, sale or
distribution of any Competing Product in the Territory solely to the extent that
the marketing, sale or distribution of such Competing Product by Noven (or its
Affiliates or sublicensees) is the result of Noven (or its Affiliates or
sublicensees) having acquired the Competing Product from the acquisition of, or
merger with another Person who at the time of acquisition possessed such
Competing Product and/or was marketing, selling and/or distributing it in the
Territory, Noven, its Affiliate or sublicensee shall ***.
(b) Noven recognizes that the territorial, time and scope limitations
set forth in this Section 7.5 are reasonable and are required for the protection
of Novartis, its Affiliates and sublicensees. Further, Noven specifically
recognizes that any breach by it of this Section 7.5 may cause irreparable
injury to the Novartis, its Affiliates and sublicensees (including, without
limitation, Vivelle) 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), Noven agrees that in the event of any such
breach, notwithstanding the provisions of Section 11.1, Novartis 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.
ARTICLE VIII
INDEMNIFICATION
8.1. 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) ***.
(b) ***.
(c) 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,
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any and all Losses, which the Noven 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
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 8.1(c);
(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.
(d) Noven shall defend, indemnify and hold the 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 the Noven License Agreement; (ii)
any material breach by Noven or any of its Affiliates or sublicensees, or
material failure by any of them to comply with, any covenants or obligations of
Noven pursuant to this Agreement or the Noven License Agreement; (iii) the
enforcement by the Novartis Indemnitees of their rights under this Section
8.1(d); (iv) any gross negligence or willful misconduct by Noven or its
Affiliates in Noven's performance pursuant to this Agreement or the Noven
License Agreement; and (v) Noven's material violation of any applicable 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.
(e) If any Claim arises as to which a right of indemnification
provided in this Article VIII applies, the Person seeking indemnification (the
"indemnified party"), shall promptly notify the Party obligated under this
Article VIII 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 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 VIII 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 VIII applies, as incurred.
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ARTICLE IX
TERM AND TERMINATION; REMEDIES
9.1. TERM. The term of this Agreement shall commence on the Closing
Date and, with respect to the sublicense granted pursuant to Section 2.1 shall
expire, unless sooner terminated as set forth herein, upon the expiration or
termination of the licenses granted to Aventis by Noven under the Noven License
Agreement. For purposes of this Section 9.1: (a) the licenses granted to Aventis
under the Noven License Agreement shall be deemed to include any licenses
obtained by Aventis pursuant to Article 8.3(b) of the Noven License Agreement;
and (b) Novartis shall have the benefit of, and the right to exercise, the
rights and options granted to Aventis pursuant to Article 8.1(c) of the Noven
License Agreement. Commencing on the first to expire of any patent in the United
States included under Noven's Patent Rights (as defined in the Noven License
Agreement), Novartis shall have the right, exercisable by notice in writing to
Noven on a Licensed Product-by-Licensed Product basis upon the launch of any
product on to the market in the United States which is "AB rated" to such
Licensed Product, to require Noven to negotiate in good faith the fees provided
for in any arrangement for supply of any Licensed Product to Novartis, its
Affiliates or sublicensees in the United States.
9.2. TERMINATION FOR BANKRUPTCY. Any of Noven, Novartis or Aventis 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.
9.3. NOVEN TERMINATION RIGHT. (a) With respect to each Licensed
Product, and for a period beginning on the date hereof and ending ***, Noven
shall have the right to terminate this Agreement at any time upon thirty (30)
days' notice in any country of the Territory in which Novartis, its sublicensee,
or a Novartis Affiliate markets, sells or distributes any transdermal product
that is identical or substantially similar to such Licensed Product ("OFFENDING
PRODUCT"), unless Novartis shall effect cessation of such activity or
divestiture of such Affiliate, or take action towards such cessation or such
divestiture within 6 months of the commencement of such activity or Novartis'
acquisition of such Affiliate; PROVIDED, HOWEVER, that this right of termination
does not apply (i) with respect to the countries in the European Economic Area,
***.
(b) With respect to each Licensed Product, and for a period beginning
on the date hereof and ending ***, if Novartis or any Novartis Affiliate or
sublicensee markets, sells or distributes any Offending Product in a country
within the European Economic Area, then Noven, with regard to such country,
shall have the right to convert the license granted under Article 3 of the Noven
License Agreement with respect to such Licensed Product to a non-exclusive
license; PROVIDED, HOWEVER, that this right shall not apply: (i) if Novartis
shall effect cessation of such activity or divestiture of such Affiliate or take
action towards such cessation or such divestiture within six months of the
commencement of such activity or Novartis' acquisition of such Affiliate; ***.
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(c) Notwithstanding Sections 9.3(a) and (b) above, with respect to the
marketing, sale or distribution of any transdermal product that is identical or
substantially similar to a Licensed Product in the Territory solely to the
extent that the marketing, sale or distribution of such product by Novartis (or
its Affiliates or sublicensees) is the result of Novartis (or its Affiliates or
sublicensees) having acquired the products from the acquisition of, or merger
with another Person who at the time of acquisition possessed such products
and/or was marketing, selling and/or distributing them in the Territory,
Novartis, its Affiliate or sublicensee may, instead of ceasing such activity or
divesting such product or Person, elect to pay to Noven reasonable compensation
agreed by the parties in good faith with respect thereto at the time of such
acquisition or merger, in which event, Noven shall have no right to terminate
this Agreement with respect to such Licensed Product or convert the license
granted under Article 3 of the Noven License Agreement with respect to such
Licensed Product to a non-exclusive license.
(d) Novartis recognizes that the territorial, time and scope
limitations set forth in this Section 9.3 are reasonable and are required for
the protection of Noven, its Affiliates and sublicensees.
(e) If Noven should terminate this Agreement against Novartis with
respect to any Licensed Product under this Section 9.3, it will have the rights
upon termination set forth in Section 8.3(a) of the Noven License Agreement with
respect to such Licensed Product.
9.4. REMEDIES FOR BREACH. If either of Novartis or Aventis, RPR, RPRIH
or APPI commits a material breach of this Agreement, or materially defaults in
the performance or observance of any provision of this Agreement (including the
obligations assumed by Novartis under Section 2.2), 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 Section 11.1 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 shall have the following rights:
(a) REMEDIES FOR NOVARTIS.
(i) Upon the breach of this Agreement by Aventis,
RPR, RPRIH or APPI under this Section 9.4, Novartis shall then have the
right to terminate this Agreement, exercisable by delivering written
notice thereof to Aventis, and/or to pursue any and all remedies
available to it at law or in equity including, without limitation, the
right to seek to recover from Aventis any and all damages and losses of
any nature whatsoever (but excluding consequential damages, lost
profits and punitive damages).
(ii) Without limiting any other provision of this
Agreement, Noven acknowledges that the rights and benefits granted to
Novartis pursuant to this Agreement include all rights of Aventis to
terminate the Noven License Agreement in the Territory and all rights
and benefits of Aventis upon any such termination in the Territory
pursuant to the Noven License Agreement.
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(b) REMEDIES FOR AVENTIS. ***.
(c) REMEDIES FOR NOVEN. Upon the breach by Novartis under this
Section 9.4 of any obligation owed by Novartis to Noven under this Agreement,
and subject to compliance by Noven with the provisions of this Section 9.4,
Noven shall have the right to pursue any and all remedies available to it at law
or in equity including without limitation the right to seek to recover from
Novartis any and all damages and losses of any nature whatsoever (but excluding
consequential damages, lost profits and punitive damages) and the right to
terminate this Agreement against Novartis. If Noven should terminate this
Agreement against Novartis under this Section 9.4(c), it will have the rights
upon termination set forth in Section 8.3(a) of the Noven License Agreement.
9.5. EFFECT OF TERMINATION. Rights and obligations set forth in
Sections 7.1 (Confidentiality; Press Releases), 8.1 (Indemnification) and
Articles VI (Intellectual Property Claims) and XI (Miscellaneous) shall survive
the termination of this Agreement and/or the termination of the Ongoing
Obligations, and otherwise, except as set forth in this Section 9.5, this
Agreement shall become void and have no effect; PROVIDED, HOWEVER, that any
termination of this Agreement will have no impact on the assignments pursuant to
Sections 2.6, 4.1 or 5.1 hereof, and that any termination of this Agreement by
Novartis will have no impact on the sublicense granted to Novartis pursuant to
Section 2.1 hereof or pursuant to Section 2.1 of the Existing Novartis Pharma
Sublicense Agreement. Noven hereby consents to the foregoing proviso. Nothing in
this Section 9.5 shall relieve any Party to this Agreement of any liability for
a breach of any provision of this Agreement.
9.6. ***.
9.7. REMEDIES REASONABLE. The Parties expressly acknowledge that the
remedy provisions contained in this Article IX are reasonable, considering the
intended nature and scope of this Agreement.
9.8. NO PENALTIES. Without limiting the indemnification rights set
forth in Article VIII hereof, if either Party terminates this Agreement in
accordance with the terms herein, the terminating Party shall owe no statutory
termination penalty or indemnity or other similar payment that might otherwise
be due under local law to the terminated Party on account of such termination.
9.9. 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 X
CERTAIN ADDITIONAL COVENANTS,
REPRESENTATIONS AND AGREEMENTS
10.1. ***.
10.2. ***.
ARTICLE XI
MISCELLANEOUS
11.1. DISPUTES. Except as set forth in Sections 7.3, 7.4 and 7.5(b) and
notwithstanding Article XI of the Noven License Agreement, in the event of any
controversy or claim arising out of, relating to or in connection with any
provision of this 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. Any Party may initiate
such informal dispute resolution by sending written notice of the dispute to any
other Party, and within ten (10) days after such notice appropriate
representatives of the relevant 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 Chief Executive Officer of
Novartis Pharma AG the Head of Commercial Operations of Aventis Pharma AG,
and/or 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 relevant 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.
11.2. 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 Aventis, RPR, RPRIH and APPI
shall be solely employees of Aventis, RPR, RPRIH or APPI, as the case may be,
and shall not represent themselves as employees of Novartis or Noven. All
personnel of Novartis shall be solely employees of Novartis, as applicable and
shall not represent themselves as employees of Aventis, RPR, APPI, RPRIH or
Noven. All personnel of Noven shall be solely employees of Noven as applicable
and shall not represent themselves as employees of Aventis, RPR, APPI, RPRIH or
Novartis.
11.3. ASSIGNMENT. Neither Aventis 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
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each of Aventis 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 Aventis 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.
11.4. 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.
11.5. AMENDMENT. This Agreement may only be modified, amended or
supplemented by an instrument in writing executed by Aventis and Novartis, and,
as applicable, consented to by Noven.
11.6. 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.
11.7. 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: If to Aventis:
Novartis Pharma XX Xxxxx Pharmaceutical Products, Inc.
Xxxxxxxxxxxx 00 3711 Xxxxxxx Xxxx, Xxxxx 000
XX-0000 Xxxxx, Xxxxxxxxxxx Xxxxxxxxxx, Xxxxxxxx, XXX 00000
Fax: xx00 00 000 0000 Fax: (000) 000-0000
Attn: General Counsel Attn: President
With copies to: With a copy to:
Novartis Pharma XX Xxxxxxx Xxxxx Xxxxxxx & Xxxxxxxxx, LLP
Xxxxxxxxxxxx 00 1735 Xxxxxx Xxxxxx, 00xx Xxxxx
XX-0000 Xxxxx, Xxxxxxxxxxx Xxxxxxxxxxxx, XX 00000
Fax: xx00 00 000 0000 Fax: (000) 000-0000
Attn: Head BD & L Attn: Xxxxxx Xxxxxxx, Xx., Esq.
and
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Securities and Exchange Commission. Asterisks denote omissions.
White & Case LLP
0000 Xxxxxx xx xxx Xxxxxxxx
Xxx Xxxx, XX 00000
Fax: (000) 000-0000
Attn: Xxxxxx X. Xxxxxxxx, Esq.
If to Noven: If to APPI, RPRIH or RPR:
Noven Pharmaceuticals, Inc. x/x Xxxxxxx Xxxxxx
00000 X.X. 000xx Xxxxxx Xxxxx 000-000, P.O. Box 6880
Miami, Florida 33186 Xxxxxxxxxxx, XX 00000-0000
Fax: (000) 000-0000 Fax: (000) 000-0000
Attn: Xxxxxx X. Xxxxxxx, President, Attn: General Counsel
and Xxxxxxx X. Xxxxxxxxx, Esq.,
General Counsel
With a copy to: In each case with a copy to:
Xxxxx & Lardner Xxxxxxx Xxxxx Xxxxxxx & Xxxxxxxxx, LLP
Washington Harbour 0000 Xxxxxx Xxxxxx, 00xx Xxxxx
0000 X Xxxxxx, X.X. Xxxxxxxxxxxx, XX 00000
Xxxxxxxxxx, X.X. 00000-0000 Fax: (000) 000-0000
Fax: (000) 000-0000 Attn: Xxxxxx Xxxxxxx, Xx., Esq.
Attn: Xxxxxxx X. Xxxxxxx, Esq.
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.
11.8. 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
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.
11.9. 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
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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.
11.10. 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.
11.11. 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.
11.12. ENTIRE AGREEMENT. This Agreement, including all exhibits and
schedules and the Related Agreements, the Existing Novartis Pharma Sublicense
Agreement and, with respect to Noven and Novartis only, 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.
11.13. 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.
11.14. INCONSISTENCY. In the event of any inconsistency between the
terms of this Agreement and the Existing Novartis Pharma Sublicense Agreement,
the terms of this Agreement shall prevail.
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IN WITNESS WHEREOF, the Parties hereto have executed this Sublicense
Agreement as of date first above written.
XXXXX PHARMACEUTICAL PRODUCTS, INC.
By: /s/ Xxxxxxx X. Xxxxxxx
------------------------------------------
Xxxxxxx X. Xxxxxxx
President
XXXXX-XXXXXXX XXXXX INC.
By: /s/ Xxxxxxx X. Xxxxxx
------------------------------------------
Xxxxxxx X. Xxxxxx
Vice President
AVENTIS PHARMACEUTICALS PRODUCTS INC.
By: /s/ Xxxxxxx X. Xxxxxx
------------------------------------------
Xxxxxxx X. Xxxxxx
Vice President
XXXXX-XXXXXXX XXXXX INTERNATIONAL HOLDINGS INC.
By: /s/ Xxxxxxx X. Xxxxxxx
------------------------------------------
Xxxxxxx X. Xxxxxxx
President
NOVARTIS PHARMA AG
By: /s/ Xxxxxx Xxxxxxxx
------------------------------------------
Xxxxxx Xxxxxxxx
Head Licensing Europe, Business
Development and Licensing
By: /s/ Xxxxxx Xxxxxxxxx
------------------------------------------
Xxxxxx Xxxxxxxxx
Legal Counsel
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Securities and Exchange Commission. Asterisks denote omissions.
Consented to with respect to the following provisions: Section 2.1 (Sublicense
to the Sublicensed Noven Intellectual Property); Section 2.2 (Assumption of
Obligations); Section 2.3 (Retention of Rights); Section 2.4 (Right to
Sublicense); Section 3.2 (Payment of Noven's Patent Costs); Sections 6.1, 6.2
and 6.5 (Infringement and Other Third Party Claims); Section 7.2(e)
(Noncompetition); Section 7.5 (Noncompetition by Noven); Article VIII
(Indemnification); Sections 9.1, 9.2, 9.3, 9.4, 9.5, 9.7, 9.8 and 9.9 (relating
generally to Term, Termination, Remedies and Penalties) and Article XI
(Miscellaneous).
NOVEN PHARMACEUTICALS, INC.
By: /s/ Xxxxxx X. Xxxxxxx
--------------------------------------------
Xxxxxx X. Xxxxxxx
President, Chief Executive Officer
Co-Chairman
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