1
Exhibit 10.17
================================================================================
AMENDED AND RESTATED LIMITED ASSIGNMENT AGREEMENT
By and Among
NOVARTIS PHARMACEUTICALS CORPORATION,
NOVEN PHARMACEUTICALS, INC.
and
VIVELLE VENTURES LLC
Dated as of April 1, 1999
================================================================================
2
AMENDED AND RESTATED LIMITED ASSIGNMENT AGREEMENT
AMENDED AND RESTATED LIMITED ASSIGNMENT AGREEMENT dated as of
April 1, 1999 (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 that certain Amended and
Restated Supply Agreement dated as of April 1, 1999 by and between Noven and
Novartis (the "Amended and Restated Supply 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 Amended and Restated Supply Agreement, pursuant to which
Noven has agreed to supply Novartis with Finished Product and Novartis has
agreed to purchase annually certain minimum quantities of such Finished Product;
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;
WHEREAS, Novartis and Noven agreed in connection with the
formation of the LLC that Novartis would, as its contribution to LLC, among
other things, make a limited assignment to LLC of its rights and obligations
under the Supply Agreement as may be amended from time to time; and
WHEREAS, LLC desires to obtain the rights under the Amended
and Restated Supply Agreement and is willing to assume the obligation to
purchase the quantities of Finished Product specified in the Amended and
Restated Supply Agreement;
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 to amend and restate the Limited Assignment Agreement to more particularly
set forth the parties' rights and obligations hereunder as follows:
1. ASSIGNMENT AND ASSUMPTION. (a) For the term of this
Agreement, Novartis hereby assigns to LLC its rights under Sections 2.9, 2.10,
4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 6.1, 6.2, 6.3,
3
7.1, 7.2, 7.3 and Article 8 of the Amended and Restated Supply Agreement (the
"Assigned Sections").
(b) For the term of this Agreement, LLC hereby accepts such
assignment and assumes and agrees to perform and discharge the duties and
obligations of Novartis arising under the Assigned Sections.
2. CONSENT TO ASSIGNMENT AND ASSUMPTION; RELEASE. For the term
of this Agreement, Noven hereby consents to the assignment by Novartis of the
rights under the Assigned Sections and the assumption by LLC of the performance,
discharge of duties and obligations arising under the Assigned Sections. For the
term of this Agreement, Noven hereby releases Novartis of all its duties and
obligations (including, without limitation, its obligation to purchase the
Annual Purchase Minimum or pay for any Finished Product purchased by LLC)
arising under the Assigned Sections.
3. RETENTION OF REMAINING RIGHTS AND OBLIGATIONS.
Notwithstanding the foregoing, Novartis retains all rights and obligations not
assigned to LLC hereby.
4. CANADA. Subject to Section 2 of that certain Sublicense
Agreement dated as of May 1, 1998 by and among Novartis, Noven and LLC (the
"Sublicense Agreement"), the parties agree that for purpose of sale to Novartis'
Canadian Affiliate, Novartis may purchase Vivelle (as that term is defined in
that certain Operating Agreement of Vivelle Ventures LLC dated as of May 1, 1998
by and between Novartis and Noven (the "Operating Agreement")) from LLC at the
price at which LLC purchases Vivelle from Noven.
5. ABSOLUTE ASSIGNMENT OF ALL RIGHTS AND OBLIGATIONS. 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, Noven and LLC shall execute an assignment agreement
assigning all of Novartis' rights and obligations under the Amended and Restated
Supply Agreement to LLC and releasing Novartis from its obligations under the
Amended and Restated Supply Agreement.
6. INDEMNIFICATION. LLC agrees and warrants to indemnify,
defend and hold harmless Noven and Novartis from and against any and all claims,
damages, expenses, attorneys' fees, settlements, and judgments arising out of
any injury or damage to a third party alleged to be caused by the Finished
Product supplied by Noven to LLC or manufactured for or by LLC; provided,
however that Noven and/or Novartis notifies LLC within twenty (20) days of
receipt of a claim or action, fully cooperates with LLC in the defense of such
claim or action, and permits LLC to control the defense and settlement of such
claim or action. Notwithstanding the above, LLC does not warrant and shall not
be liable to indemnify Noven from and against any claims, damages, expenses,
attorneys' fees, settlements and judgments arising out of any injury or damage
to a third party caused by latent defects in the
2
4
Finished Product caused by the negligence or willful misconduct on the part of
Noven, for which Noven shall have the right to control the defense and settle
such claim or action. Noven agrees and warrants to indemnify and hold harmless
LLC from and against any and all claims, damages, expenses, attorneys' fees,
settlements and judgments for personal injury to a third party caused by latent
defects in the Finished Product caused by the negligence or willful misconduct
of Noven. This provision shall survive the expiration or termination of this
Agreement.
7. RECALLS. If an authorized government agency of the United
States or any country or territory based on requirements specifically notified
to Noven by LLC shall seize any Finished Product or if LLC deems it necessary to
initiate a voluntary recall for any commercially reasonable reason, LLC shall
immediately notify Noven of such seizure or recall and shall consult with Noven
regarding the timely compliance with all pertinent state or federal regulations
pertaining thereto. Furthermore, each party shall make a permanent and complete
record of all costs incurred thereby, a copy of which shall be delivered to the
other party as soon after the completion of such recall or seizure as
practically may be done. When the cause or reason of said recall or seizure
resides in the negligent failure of Noven to manufacture in accordance with the
Specifications or applicable, notified government rules and regulations, or in
the failure of said product to maintain stability for the period described in
the product labeling, Noven shall reimburse LLC for all reasonable costs
incurred by LLC in effecting such recall or seizure, including all reasonable
credits extended to LLC's customers as a result thereof. When the cause or
reason for said recall or seizure is anything other than that set forth in the
preceding sentence, including, but not limited to, failure by other than Noven
to store, transport or care for the Finished Product, LLC shall bear all costs
of such recall or seizure and indemnify Noven therefrom including reimbursement
for all reasonable costs incurred by Noven in effecting such recall or seizure.
8. TERM; TERMINATION. The term of this Agreement and the
Parties' obligations hereunder shall be deemed to have commenced on the earlier
of the termination of the Supply Agreement or the Effective Date (as defined in
the Amended and Restated Supply Agreement) 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;
(b) the termination of the Amended and Restated Supply
Agreement; or
(c) the termination of the Restated License Agreement.
9. OBLIGATIONS UPON TERMINATION. Except as otherwise agreed by
the parties, within thirty (30) days of the effective date of the expiration or
any termination of this Agreement, LLC and any Supplier in possession of
Know-How shall cease to use and deliver to Noven, upon written request, all
Know-How, to the extent that such use is not permitted by the License Agreement
except for any documents or records which either LLC or the Supplier is required
to retain by law, and Noven shall do the same with respect to any LLC Know-How
in its possession. Noven shall deliver to LLC, at LLC's request and expense, all
Finished Product and preprinted packaging, labeling and stock materials which
are in the possession of Noven, for which LLC shall be obligated to make payment
upon delivery.
10. 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
3
5
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:
Noven Pharmaceuticals, Inc.
00000 X.X. 000xx Xxxxxx
Xxxxx, XX 00000
Attention: General Counsel
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: General Counsel, 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
4
6
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: General Counsel
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.
11. 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 11, the party affected by such force majeure
shall immediately use
5
7
its best efforts to eliminate, cure and overcome any of such causes and resume
performance of its obligations.
12. 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.
13. 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.
14. 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.
15. AMENDED AND RESTATED SUPPLY AGREEMENT. Unless otherwise
specified herein, nothing contained in this Agreement shall affect the rights
and obligations of the parties under the Amended and Restated Supply Agreement
or the Restated License Agreement, and the terms and conditions of the Amended
and Restated Supply Agreement and the Restated License Agreement shall remain in
full force and effect.
16. 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.
17. 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.
18. ENTIRE AGREEMENT. This Agreement among the parties made on
the date of execution hereof and Section 2 of the Sublicense Agreement,
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.
19. 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
6
8
signature page to this Agreement by telecopier shall be as effective as delivery
of a manually executed counterpart of this Agreement.
7
9
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 Xxxxx
---------------------------------
Name: Xxxxx Xxxxx
Title: President and Chief Executive Officer
Date: January 11, 2000
NOVEN PHARMACEUTICALS, INC.
By: /s/ Xxxxxx Xxxxxxxxx
---------------------------------
Name: Xxxxxx Xxxxxxxxx
Title: Chairman
Date: January 19, 2000
VIVELLE VENTURES LLC
By: /s/ Xxxxxx X. Xxxxxxx
---------------------------------
Name: Xxxxxx X. Xxxxxxx
Title: President
Date: January 19, 2000
8
