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EXHIBIT 10.35
SUBLICENSE AGREEMENT
By and Among
NOVARTIS PHARMACEUTICALS CORPORATION,
NOVEN PHARMACEUTICALS, INC.
and
VIVELLE VENTURES LLC
Dated as of May 1, 1998
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SUBLICENSE AGREEMENT
SUBLICENSE AGREEMENT dated as of May 1, 1998 (this "Agreement") by and
among Novartis Pharmaceuticals Corporation, a Delaware corporation ("Novartis"),
as the successor-in-interest to the Pharmaceuticals Division of Ciba-Geigy
Corporation, a New York corporation ("CIBA"), Vivelle Ventures, LLC, a Delaware
limited liability company ("LLC") and Noven Pharmaceuticals, Inc. a Delaware
corporation ("Noven"). Capitalized terms used but not otherwise defined herein
shall have the respective meanings assigned to such terms in the Restated
License Agreement dated as of November 15, 1991 by and between Noven and CIBA
(the "Restated License Agreement"), attached hereto as Exhibit A.
W I T N E S S E T H:
WHEREAS, Novartis, as successor-in-interest to Ciba, and Noven are
parties to the Restated License Agreement, pursuant to which Noven has granted
Novartis an exclusive license under the Patent Rights and Know-How, to
manufacture, have manufactured, use and sell the Licensed Products and CIBA
Products in the Territory;
WHEREAS, Novartis and Noven have formed LLC for the purpose of creating
a platform to maintain and grow a franchise in women's health, focusing
initially on the manufacture and sale of the 17(beta)-estradiol single active
ingredient in a matrix currently being marketed by Novartis under the trademark
"Vivelle" pursuant to the Restated License Agreement ("Vivelle");
WHEREAS, Novartis and Noven have agreed that in connection with the
formation of the joint venture, Novartis shall, as its contribution to LLC,
among other things, grant an exclusive sublicense to LLC of Novartis' rights
under the Restated License Agreement; and
WHEREAS, LLC desires to obtain from Novartis a sublicense to
manufacture, have manufactured, use and sell Vivelle in the United States and
the other Licensed Products and CIBA Products in the Territory;
NOW THEREFORE, in consideration of the agreements and covenants set
forth above and herein, and other good and valuable consideration, the receipt
and sufficiency of which are hereby acknowledged, the parties hereto agree as
follows:
1. Grant of Sublicense. (a) For the term of this Agreement, Novartis
hereby grants LLC (i) an exclusive sublicense to manufacture, have manufactured,
use and sell Vivelle in the United States on the terms and conditions provided
herein and (ii) an exclusive sublicense to
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manufacture, have manufactured, use and sell the other Licensed Products and
CIBA Products in the Territory on the terms and conditions provided herein;
(b) For the term of this Agreement, LLC agrees to be bound by and
perform and discharge all the duties and obligations of Novartis under the
Restated License Agreement to the extent not modified hereby.
2. Sublicense in Canada. (a) Novartis and Noven hereby grant LLC the
right to sublicense the right to use and sell the Licensed Products (other than
Vivelle) and CIBA Products in Canada.
(b) During the period in which Novartis retains the right to
manufacture, have manufactured, use and sell Vivelle in Canada, Novartis agrees
to remit to LLC all profits it realizes through sales of Vivelle to its
Affiliate in Canada within 15 days of receipt of payment therefor. During the
period in which Novartis retains the right to manufacture, have manufactured,
use and sell Vivelle in Canada, Novartis also agrees to use good faith efforts
to continue to sell Vivelle to Novartis' Canadian Affiliate on the same terms
and price that it and/or its Affiliates have been utilizing during the six
months prior to the date of this Agreement; provided that if Novartis proposes
to change the terms and/or price that it sells Vivelle to Novartis' Canadian
Affiliate it shall discuss such proposal with Noven.
(c) Novartis covenants to use commercially reasonable efforts to
resolve all issues with its Canadian Affiliate necessary for Novartis to
sublicense to LLC the right to manufacture, have manufactured, use and sell
Vivelle in Canada. Subject to and effective upon resolution of such issues to
the satisfaction of Novartis, Noven and Novartis' Canadian Affiliate as
evidenced by written agreements, Novartis and Noven hereby grant the LLC the
right to sublicense the right to use and sell Vivelle in Canada to Novartis'
Canadian Affiliate. In connection with the foregoing, LLC covenants to enter
into a long-term supply and sublicense agreement with Novartis' Canadian
Affiliate substantially on the terms presently contained in the Restated License
Agreement for the distribution of Licensed Products (including Vivelle) and CIBA
Products in Canada and, with respect to Vivelle, at the price at which Novartis'
Canadian Affiliate has been purchasing Vivelle from Novartis and/or its
Affiliates during the six months prior to the date of this Agreement.
3. Payment of Royalties. (a) In consideration for the rights granted in
Paragraph 1 above and in addition to any price paid to Noven for the supply of
any or all of the Licensed Products pursuant to any separate supply agreement or
assignment of existing supply agreement, LLC shall be obligated to pay all
royalties owed to Noven for Licensed Products and CIBA Products, during the
Royalty Period, according to the schedule set forth in Article 4 and the timing
of Royalty Payments set forth in Article 5 respectively of the Restated License
Agreement and as applied to Aggregate Net Sales in each calendar year.
(b) Noven agrees that Novartis will not be liable for, and Noven hereby
releases and holds Novartis harmless from all claims related to (i) the payment
of any royalties owed to Noven by LLC for sales of Licensed Product by LLC (ii)
the payment of any royalties owed to Noven by Novartis' Canadian Affiliate for
sales of Licensed Products (other than Vivelle) and
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CIBA Products in Canada by Novartis' Canadian Affiliate or (iii) once Novartis'
Canadian Affiliate and the LLC execute the supply and sublicense agreement
described in paragraph 2(c) above, the payment of any royalties owed to Noven by
Novartis' Canadian Affiliate for sales of Vivelle in Canada.
4. Sublicense Term; Termination. This Sublicense is effective upon the
date of its execution by Novartis and LLC and shall continue in effect until the
earlier to occur of the following events:
(a) the dissolution of LLC as provided in Article X of the
Operating Agreement dated as of May 1, 1998 between Novartis and Noven; or
(b) the termination of the Restated License Agreement.
On termination of this Agreement, LLC shall return to Novartis all documented or
written Know-How provided by Novartis under this Agreement and LLC shall have no
further right or license hereunder to Noven's Know-How or Patent Rights.
5. Breach; Termination. This Agreement may be terminated by Novartis on
a product-by-product basis (without prejudice to any of its other rights), in
the event of a material breach by LLC, provided that LLC is given written notice
of such claimed breach and a reasonable time, not to exceed sixty (60) days, in
which to cure such breach. Such period to cure may be extended for up to thirty
(30) days, upon written request, if such additional time is reasonably necessary
to effect such cure and provided that such breaching party is using its
reasonable efforts to diligently pursue such cure. The right to terminate this
Agreement, as provided herein, shall not be affected in any way by a waiver of,
or failure to take action with respect to, any previous default. On termination
of this Agreement, LLC shall return to Novartis all documented or written
Know-How provided by Novartis under this Agreement and LLC shall have no further
right or license hereunder to Noven's Know-How or Patent Rights.
6. New Product Development. Noven shall use commercially reasonable
efforts to develop follow-on products to Vivelle, including Vivelle II (as that
term is defined in the Operating Agreement), under the terms of the Restated
License Agreement.
7. Absolute Assignment of Restated License Agreement. In the event that
Noven purchases all of Novartis' Interest (as that term is defined in the
Operating Agreement) in LLC pursuant to Section 9.5 of the Operating Agreement,
Novartis and Noven shall execute an assignment agreement assigning all of
Novartis' rights and obligations under the Restated License Agreement to LLC and
releasing Novartis from its obligations under the Restated License Agreement. In
addition, Novartis shall transfer to Noven the NDA relating to the Milestone
Products, ANDA No. 73-418, and any NDA or ANDA relating other Licensed Products
and shall return to Noven all documented or written Know-How provided by Noven
under the Restated License Agreement.
8. Noven Payments. Noven agrees that for purposes of the payment
required under Article 13.4 a) 2) of the Restated License Agreement, the amounts
paid by LLC to Noven
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shall be considered part of the total payments made by Novartis to Noven within
the thirty (30) day period of the date of termination.
9. Notices. Any notice or communication required or permitted to be
given or made under this Agreement by one of the parties hereto shall be in
writing and shall be deemed to have been sufficiently given or made for all
purposes if mailed by certified mail, postage prepaid, addressed to such other
party at its respective address as follows:
(a) If to Noven, to:
Noven Pharmaceuticals, Inc.
00000 X.X. 000xx Xxxxxx
Xxxxx, XX 00000
Attention: Xx. Xxxxxx X. Xxxxxxx, President and Chief
Executive Officer
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
with a copy to:
Xxxxx & Lardner
0000 X Xxxxxx, X.X.
Xxxxx 000
Xxxxxxxxxx, X.X. 00000
Attention: Xxxxx Xxxxx, Esq.
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
or to such other person or address as Noven shall furnish to
the other parties hereto in writing.
(b) If to Novartis, to:
Novartis Pharmaceuticals Corporation
00 Xxxxx 00
Xxxx Xxxxxxx, XX 00000
Attention: Office of the CEO
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
with copies to:
Novartis Pharmaceuticals Corporation
00 Xxxxx 00
Xxxx Xxxxxxx, XX 00000
Attention: Xxxxxx Xxxxxxx, Esq., Legal Department
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
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and
White & Case LLP
0000 Xxxxxx xx xxx Xxxxxxxx
Xxx Xxxx, XX 00000
Attention: Xxxxxxx X. Xxxxx, Xx., Esq.
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
or to such other person or address as Novartis shall furnish
to the other parties hereto in writing.
(c) If to LLC, to:
Vivelle Ventures LLC
c/o Noven Pharmaceuticals, Inc.
00000 X.X. 000xx Xxxxxx
Xxxxx, XX 00000
Attention: Xx. Xxxxxx X. Xxxxxxx, President
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
with copies to:
Novartis Pharmaceuticals Corporation
00 Xxxxx 00
Xxxx Xxxxxxx, XX 00000
Attention: Xxxxxx Xxxxxxx, Esq., Legal Department
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
and
White & Case LLP
0000 Xxxxxx xx xxx Xxxxxxxx
Xxx Xxxx, XX 00000
Attention: Xxxxxxx X. Xxxxx, Xx., Esq.
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
or to such other person or address as LLC shall furnish to the
other parties hereto in writing.
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10. Force Majeure. Neither party shall be responsible or liable to the
other hereunder for failure or delay in performance of this Agreement due to any
war, fire, accident or other casualty, or any labor disturbance or act of God or
the public enemy, or any other unforeseeable contingency beyond such party's
control. In addition, in the event of the applicability of this Paragraph, the
party affected by such force majeure shall immediately use its best efforts to
eliminate, cure and overcome any of such causes and resume performance of its
obligations.
11. Assignment. This Agreement and all rights and obligations hereunder
are personal to the parties hereto and may not be assigned, other than to
Affiliates of Novartis, without the express prior written consent of the other.
Any assignment or attempt at same in the absence of such prior written consent
shall be void and without effect.
12. Applicable Law. This Agreement shall be construed, and the rights
of the parties determined, in accordance with the laws of the State of New York
without regard to choice of law principles of the State of New York.
13. Severability. If any one or more of the provisions of this
Agreement shall be held to be invalid, illegal or unenforceable, the validity,
legality or enforceability of the remaining provisions hereof shall not in any
way be affected or impaired thereby. In the event any provisions shall be held
invalid, illegal or unenforceable the parties shall use best efforts to
substitute a valid, legal and enforceable provision, which insofar as possible,
implements the purposes hereof. The same principle shall apply in respect of the
filling of any contractual gap.
14. No Waiver. The failure of any party hereto at any time or times to
require performance of any provisions hereof shall in no manner affect its right
to enforce such provision at a later time. No waiver by any party hereto of any
condition nor the breach of any term, covenant or representation contained in
this Agreement whether by conduct or otherwise in any one or more instances
shall be deemed to be or construed as a further or continuing waiver of such
condition or breach or a waiver of any other condition or deemed to be or
construed as the breach of any other term, covenant or representation in this
Agreement.
15. Draftsmanship. The parties acknowledge and agree that this
Agreement is the product of extensive negotiation and neither party will be
deemed to have drafted this Agreement.
16. Entire Agreement. This Agreement among the parties made on the date
of execution hereof, constitute the entire understanding among the parties
relating to the subject matter hereof, and no amendment or modification to this
Agreement shall be valid or binding upon the parties unless made in writing and
signed by the representatives of such parties.
17. Counterparts. This Agreement and any amendments hereto may be
executed in one or more counterparts, each of which shall be deemed an original,
but all of which together will constitute one and the same instrument. Delivery
of an executed counterpart of a signature page to this Agreement by telecopier
shall be as effective as delivery of a manually executed counterpart of this
Agreement.
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IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed by their duly authorized representatives as of the day and year first
written above.
NOVARTIS PHARMACEUTICALS CORPORATION
By: /s/ Xxxxx X. Xxxxxx
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Title: President and Chief Executive Officer
NOVEN PHARMACEUTICALS, INC.
By: /s/ Xxxxxx Xxxxxxxxx
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Title: Chairman
VIVELLE VENTURES LLC
By: /s/ Xxxxxx X. Xxxxxxx
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Title: President
