Exhibit 10.4
LICENSE OPTION AGREEMENT
This License Option Agreement (the "Agreement") is made
as of the 5th day of September, 1997 by and between ALZA
Corporation, a Delaware corporation ("ALZA"), and Crescendo
Pharmaceuticals Corporation, a Delaware corporation
("Crescendo").
BACKGROUND
A. Crescendo has been formed for the purpose
of selecting and developing human pharmaceutical products,
including products using ALZA Technology (as defined herein)
and commercializing such products, most likely through
licensing to ALZA.
B. As of the date hereof, ALZA and Crescendo
have entered
into a Technology License Agreement and a Development
Agreement.
C. Crescendo desires to grant to ALZA an option to
commercialize the products developed by Crescendo under the
Development Agreement as set forth herein.
Now, therefore, the parties agree as follows:
1. Definitions.
For purposes of this Agreement, the following terms shall
have the meanings set forth below:
1.1 "Affiliate" shall mean a corporation or any
other entity that directly, or indirectly through one or
more intermediaries, controls, is controlled by, or is under
common control with, the designated party. "Control" shall
mean ownership of at least 50% of the shares of stock
entitled to vote for the election of directors in the case
of a corporation, and at least 50% of the interests in
profits in the case of a business entity other than a
corporation.
1.2 "Crescendo Product" shall mean an Identified
Product, or another human pharmaceutical product which has
been recommended by ALZA and accepted by Crescendo's
independent Board of Directors for development as such under
the Development Agreement.
1.3 "Development Agreement" shall mean the
Development Agreement dated as of the date hereof between
ALZA and Crescendo.
1.4 "Distribution" shall mean ALZA's distribution
of all of the outstanding shares of Class A Common Stock of
Crescendo to ALZA's stockholders and debenture holders of
record on September 18,
1997.
1.5 "FDA" shall mean the United States Food and
Drug Administration or any successor agency whose clearance
is necessary to market a Crescendo Product in the United
States.
1.6 "Identified Products" shall mean, upon the
closing of ALZA's purchase of the outstanding shares of
Therapeutic Discovery Corporation, the following products:
OROSr oxybutynin, ▇▇▇▇▇▇ leuprolide, OROSr methylphenidate,
IUTS progesterone, D-TRANST testosterone matrix, E-TRANST
LHRH and E-TRANST (skin interface technology) insulin.
1.7 "License Agreement" shall mean an exclusive
license agreement for a particular Crescendo Product between
ALZA and Crescendo, in the form of Exhibit A to this
Agreement.
1.8 "License Option" shall mean the option
granted to ALZA pursuant to Section 2 of this Agreement.
1.9 "Product Payments" shall have the meaning set
forth in Section 3.1 of the License Agreement.
1.10 "Proprietary Rights" shall mean data,
inventions, information, processes, know-how and trade
secrets, and patents or patent applications claiming any of
the foregoing, owned by, licensed to or controlled by a
person and which such person has the right to license or
sublicense. Proprietary Rights shall not include
trademarks.
1.11 "Purchase Option" shall mean that certain
option contained in Crescendo's Restated Certificate of
Incorporation pursuant to which ALZA has the right to
purchase all of the outstanding shares of Crescendo Class A
Common Stock.
1.12 "Technology License Agreement" shall mean the
Technology License Agreement dated as of the date hereof
between ALZA and Crescendo.
2. License Option.
2.1 Grant of License Option. On the terms and
subject to the conditions of this Agreement, Crescendo
hereby grants to ALZA an option to obtain an exclusive
license with respect to each Crescendo Product, exercisable
on a product-by-product and country-by-country basis as
described in Section 2.2.
2.2 Time for Exercise.
(a) ALZA may exercise the License Option
with respect to Product on a country-by-country basis at any
time during the period beginning on the date hereof and
ending (i) with respect to the ▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇ days after
clearance by the FDA to market such Crescendo Product in the
United States, and (ii) with respect to any other country,
90 days after the earlier of (A) clearance by the
appropriate regulatory agency to market such Crescendo
Product in such country and (B) clearance by the FDA to
market such Crescendo Product in the United States.
Notwithstanding the foregoing, the License Option shall
expire, to the extent not previously exercised, at the close
of business on the 30th day after the expiration of the
Purchase Option or, with respect to a particular Crescendo
Product, upon exercise by ALZA of the global buy-out option
for such Crescendo Product under the License Agreement for
such Crescendo Product. In any case, ALZA must exercise the
License Option for a particular Crescendo Product in a
particular country prior to the first commercial sale of
such product in such country by ALZA or any of its
Affiliates, sublicensees, distributors or marketing
partners.
(b) The License Option for any Crescendo
Product in any country will expire if not exercised within
the time periods described above. In addition, the License
Option for any Crescendo Product will expire, with respect
to all countries for which it has not yet been exercised,
upon exercise by ALZA of the global buy-out option for such
Crescendo Product under the License Agreement for such
Crescendo Product.
(c) Crescendo will notify ALZA in writing
within 10 business days of receipt of each clearance to
market any Crescendo Product in any country.
2.3 Manner of Exercise. ALZA shall exercise its
License Option by delivering to Crescendo, within the time
period described in Section 2.2 above, a written notice of
exercise specifying the Crescendo Product and the country or
countries as to which the License Option is exercised. A
License Agreement for such Crescendo Product shall be deemed
to be effective in such country or countries as of the date
of such notice of exercise, without the necessity of any
additional action by the parties. For the convenience of
the parties, however, ALZA shall, promptly after delivery of
such notice, forward to Crescendo two executed copies of a
License Agreement dated the effective date thereof and
containing completed Attachments A and B. Crescendo shall
execute both copies and return one to ALZA as soon as
possible. Failure of either or both of the parties to
execute such License Agreement shall not, however, affect
the effectiveness of the license granted thereby. The
parties shall enter into a separate License Agreement for
each Crescendo Product as to which ALZA elects to exercise a
License Option. For convenience, the parties shall amend
Attachment B to a License Agreement to add a country or
countries in cases where a License Option is being exercised
for a Crescendo Product for which a License Option already
has been exercised in another country or countries. Such
amendment shall set forth the additional country or
countries and the dates of exercise of the License Option
for such countries.
2.4 Development Assets. If ALZA does not
exercise the License Option for any Crescendo Product in any
country prior to the expiration of such License Option or,
if ALZA notifies Crescendo that it will not exercise the
License Option for a Crescendo Product, ALZA shall make
available to Crescendo for further development and
commercialization activities at no charge, all clinical
supplies, materials and other assets purchased, manufactured
or developed for use in the development of such Crescendo
Product with respect to such country to the extent such
assets will not be used under the Development Agreement.
3. No Conflict.
Crescendo agrees that no license, sale or other
commercialization of any Crescendo Product has been or shall
be made or offered to any person or entity on any basis that
is or will be in conflict with this Agreement or any License
Agreement.
4. Access To Information.
4.1 Information Available to ALZA. Crescendo
shall make available to ALZA, at all reasonable times, all
available information relating to all Crescendo Products as
to which the License Option remains exercisable so as to
enable ALZA to determine whether and when to exercise its
License Option.
4.2 Consultation with ALZA. Crescendo shall
consult with ALZA and inform ALZA on a continuing basis of
the current state of development of all Crescendo Products
as to which the License Option remains exercisable and will
review from time to time with ALZA the progress towards
completion of the Crescendo Products.
4.3 Consultation with Crescendo. In the event
that the License Option with respect to one or more
Crescendo Products in one or more countries expires
unexercised, ALZA shall make available to Crescendo all
information reasonably available to ALZA relating to such
Crescendo Products and ALZA's previous contacts with
potential sublicensees, distributors or marketing partners
for such Crescendo Products in such countries.
5. Effective Date; Termination.
5.1 Effective Date. This Agreement will become
effective on the date of the Distribution.
5.2 Termination. This Agreement shall terminate
on the earlier of (a) the date of expiration of the License
Option for all of the Crescendo Products and (b) 30 days
after expiration of the Purchase Option.
6. Miscellaneous.
6.1 Waiver, Remedies and Amendment. Any waiver by
either party hereto of a breach of any provisions of this
Agreement shall not be implied and shall not be valid unless
such waiver is recited in writing and signed by such party.
Failure of any party to require, in one or more instances,
performance by the other party in strict accordance with the
terms and conditions of this Agreement shall not be deemed a
waiver or relinquishment of the future performance of any
such terms or conditions or of any other terms and
conditions of this Agreement. A waiver by either party of
any term or condition of this Agreement shall not be deemed
or construed to be a waiver of such term or condition for
any other term. All rights, remedies, undertakings,
obligations and agreements contained in this Agreement shall
be cumulative and none of them shall be a limitation of any
other remedy, right, undertaking, obligation or agreement of
either party. This Agreement may not be amended except in a
writing signed by both parties.
6.2 Assignment. Neither party may assign its
rights and obligations hereunder without the prior written
consent of the other party, which consent may not be
unreasonably withheld; provided, however, that ALZA may
assign such rights and obligations hereunder to an Affiliate
of ALZA or any person or entity with which ALZA is merged or
consolidated or which acquires all or substantially all of
the assets of ALZA.
6.3 Arbitration.
(a) All disputes which may arise under, out
of or in connection with this Agreement shall be settled by
arbitration conducted in the city of San Francisco, State of
California, in accordance with the then existing rules of
the American Arbitration Association, and judgment upon the
award rendered by the arbitrators may be entered in any
court having jurisdiction thereof. The parties hereby agree
that service of any notices in the course of such
arbitration at their respective addresses as provided for in
Section 6.7 of this Agreement shall be valid and sufficient.
(b) In any arbitration pursuant to this
Section 6.3, the award shall be rendered by a majority of
the members of a board of arbitration consisting of three
members who shall be appointed by the parties jointly, or if
the parties cannot agree as to three arbitrators within 30
days after the commencement of the arbitration proceeding,
then one arbitrator shall be appointed by ALZA and one
arbitrator shall be appointed by Crescendo within 60 days
after the commencement of the arbitration proceeding. The
third arbitrator shall be appointed by mutual agreement of
such two arbitrators. In the event of failure of the two
arbitrators to agree within 75 days after commencement of
the arbitration proceeding upon the appointment of the third
arbitrator, the third arbitrator shall be appointed by the
American Arbitration Association in accordance with its then
existing rules. Notwithstanding the foregoing, in the event
that any party shall fail to appoint an arbitrator it is
required to appoint within the specified time period, such
arbitrator and the third arbitrator shall be appointed by
the American Arbitration Association in accordance with its
then existing rules. For purposes of this Section 6.3, the
"commencement of the arbitration proceeding" shall be deemed
to be the date upon which a written demand for arbitration
is received by the American Arbitration Association from one
of the parties.
6.4 Counterparts. This Agreement may be executed
in any number of counterparts, each of which when so
executed shall be deemed to be an original and all of which
when taken together shall constitute this Agreement.
6.5 Governing Law. This Agreement shall be
governed by and construed in accordance with the laws of the
state of California as applied to residents of that state
entering into contracts wholly to be performed in that
state.
6.6 Headings. The section headings contained in
this Agreement are included for convenience only and form no
part of the greement between the parties.
6.7 Notices. Notices required under this
Agreement shall be in writing and sent by registered or
certified mail, postage prepaid, or by facsimile and
confirmed by registered or certified mail and addressed as
follows:
If to ALZA: ALZA Corporation
▇▇▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇▇
▇▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇
Facsimile: (▇▇▇) ▇▇▇-▇▇▇▇
Attention: Senior Vice President and
General Counsel
If to Crescendo: Crescendo PharmaceuticalsCorporation
▇▇▇▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇▇
▇▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇
Facsimile: (▇▇▇) ▇▇▇-▇▇▇▇
Attention: President and
Chief Executive Officer
All notices shall be deemed to be effective five days
after the date of mailing or upon receipt if sent by
facsimile (but only if followed by certified or registered
confirmation). Either party may change the address at which
notice is to be received by written notice pursuant to this
Section 6.7.
6.8 Severability. If any provision of this
Agreement is held by a court of competent jurisdiction to be
invalid or unenforceable, it shall be modified, if possible,
to the minimum extent necessary to make it valid and
enforceable or, if such modification is not possible, it
shall be stricken and the remaining provisions shall remain
in full force and effect.
6.9 Relationship of the Parties. For purposes of
this Agreement, Crescendo and ALZA shall be deemed to be
independent contractors, and anything in this Agreement to
the contrary notwithstanding, nothing herein shall be deemed
to constitute Crescendo and ALZA as partners, joint
venturers, co-owners, an association or any entity separate
and apart from each party itself, nor shall this Agreement
constitute any party hereto an employee or agent, legal or
otherwise, of the other party for any purposes whatsoever.
Neither party hereto is authorized to make any statements or
representations on behalf of the other party or in any way
obligate the other party, except as expressly authorized in
writing by the other party. Anything in this Agreement to
the contrary notwithstanding, no party hereto shall assume
nor shall be liable for any liabilities or obligations of
the other party, whether past, present or future.
6.10 Survival. The provisions of Sections 1, 2.4,
4.3, 6.1, 6.3, 6.5, 6.7, 6.8, 6.9 and this Section 6.10
shall survive the termination for any reason of this
Agreement. Any payments due under this Agreement with
respect to any period prior to its termination shall be made
notwithstanding the termination of this Agreement. Neither
party shall be liable to the other due to the termination of
this Agreement as provided herein, whether in loss of good
will, anticipated profits or otherwise.
IN WITNESS WHEREOF, the parties have executed this
Agreement as of the date first set forth above.
ALZA CORPORATION
By: /s/ ▇▇▇▇▇ ▇. Staple
Title: Senior Vice President
and General Counsel
CRESCENDO PHARMACEUTICALS CORPORATION
By: /s/ ▇▇. ▇▇▇▇▇ ▇. ▇▇▇▇▇
Title: President and
Chief Executive Officer
EXHIBIT A
FORM OF LICENSE AGREEMENT
This License Agreement (the "Agreement") is made this
____ day of _______________ , _____, by and between ALZA
Corporation, a Delaware corporation ("ALZA"), and Crescendo
Pharmaceuticals Corporation ("Crescendo"), a Delaware
corporation.
BACKGROUND
A. Crescendo and ALZA have entered into a License
Option Agreement and certain other agreements dated as of
September 5, 1997.
B. Section 2 of the License Option Agreement provides
for a license, the terms of which are to be set forth
herein.
Now, therefore, the parties agree as follows:
1. Definitions.
For purposes of this Agreement, the following terms shall
have the meanings set forth below:
1.1 "Affiliate" shall mean a corporation or any
other entity that directly, or indirectly through one or
more intermediaries, controls, is controlled by, or is under
common control with, the designated party. "Control" shall
mean ownership of at least 50% of the shares of stock
entitled to vote for the election of directors in the case
of a corporation, and at least 50% of the interests in
profits in the case of a business entity other than a
corporation.
1.2 "Development Agreement" shall mean the
Development Agreement between ALZA and Crescendo dated as of
September 5, 1997.
1.3 "Development Cost(s)" shall mean the cost of
activities undertaken pursuant to the Development Agreement
with respect to the Licensed Product, determined in
accordance with Exhibit A thereto.
1.4 "Infringing Product" shall mean any product
sold by a third party, other than pursuant to an agreement
with ALZA, (i) which incorporates the same therapeutic agent
or agents as incorporated in the Licensed Product and (ii)
in the case of a Licensed Product using an ALZA drug
delivery system, which incorporates a delivery system
substantially similar to that incorporated in the Licensed
Product, and (iii) which infringes or is alleged to infringe
any patent or patents owned by, licensed to or controlled by
ALZA.
1.5 "License Option Agreement" shall mean the
License
Option Agreement between ALZA and Crescendo dated as of
September 5, 1997.
1.6 "Licensed Product" shall mean the product
listed on Exhibit A hereto.
1.7 "Major Market Country" shall mean any of the
following countries: the United States, France, Germany,
Italy, Japan or the United Kingdom.
1.8 "Net Sales" shall mean the total amount
invoiced in United States dollars (or converted thereto in
accordance with Section 5.2 hereof) on sales of a Licensed
Product by ALZA (or its Affiliates) or any ALZA sublicensee,
distributor or marketing partner (or its Affiliates) to
unrelated third parties such as wholesalers, hospitals and
others, in bona fide arm's-length transactions, less the
following deductions, in each case related specifically to
the Licensed Product and actually allowed and taken and not
otherwise recovered by or reimbursed to ALZA (or its
Affiliates) or such sublicensee, distributor or marketing
partner (or its Affiliates): (i) trade, cash and quantity
discounts; (ii) taxes on sales (such as sales or use taxes)
to the extent added to the sales price and set forth
separately as such in the total amount invoiced; (iii)
freight, insurance and other transportation charges to the
extent added to the sales price and set forth separately as
such in the total amount invoiced; and (iv) amounts repaid
or credited by reason of rejections, defects or returns or
because of retroactive price reductions, chargebacks or
rebates under government programs. Net Sales shall also
include the fair market value of all other consideration
received (a) by ALZA (or its Affiliates) with respect to
sales by them of the Licensed Product to unrelated third
parties from persons other than sublicensees, distributors
or marketing partners (or their Affiliates) or (b) by any
ALZA sublicensee, distributor or marketing partner (or its
Affiliates) with respect to their sales of the Licensed
Product to unrelated third parties, in each case whether
such consideration is in cash, payment in kind, exchange or
other form.
1.9 "Territory" shall mean the country or
countries listed on Exhibit B hereto, as amended from time
to time by the parties in connection with the exercise by
ALZA of its option for additional countries under the
License Option Agreement or the surrender by ALZA of its
rights to commercialize the Licensed Product in any country
or countries.
2. Grant of License.
2.1 Grant. Crescendo hereby grants to ALZA an
exclusive, perpetual license, with the right to sublicense,
to develop, make, have made and use the Licensed Product and
to sell and have sold the Licensed Product in the Territory.
ALZA agrees to use diligent efforts to conduct or have
conducted any remaining activities necessary to complete the
development of the Licensed Product in the Territory through
regulatory clearance to market the Licensed Product in the
Territory. Such activities will be undertaken at no cost to
Crescendo, unless Crescendo agrees otherwise in writing.
Promptly after regulatory clearance, ALZA shall commence and
continue to use diligent efforts to commercialize the
Licensed Product in each Major Market Country of the
Territory through the manufacture and sale or the
sublicensing of the Licensed Product, devoting to the
Licensed Product the same resources as other pharmaceutical
companies of similar size devote to products with similar
market potential and with similar relative importance to
their product portfolios. ALZA may use reasonable business
discretion in the allocation of its technological and
monetary resources in performing its obligations hereunder,
taking into account not only the Licensed Product but also
activities for its own account and its obligations under its
other agreements with third parties. Crescendo acknowledges
that ALZA will continue to own and have the right to use any
clinical supplies, materials and other assets purchased,
manufactured or developed for use in the development of such
Licensed Product, without any additional payment to or
reimbursement of Crescendo.
2.2 No Other Commercialization. ALZA shall not
commercialize the Licensed Product in any country except
pursuant to this Agreement.
3. Product Payments.
3.1 Payments.
(a) In consideration of the grant of the
license, ALZA shall make payments to Crescendo ("Product
Payments") with respect to the Licensed Product as follows:
1% of Net Sales of the Licensed Product in the Territory,
plus an additional 0.1% of such Net Sales for each full $1
million of Development Costs of the Licensed Product paid by
Crescendo. Notwithstanding the foregoing, Product Payments
for any quarter will not exceed 2.5% of Net Sales, on a
quarterly basis, in the Territory for the first four
calendar quarters during which the Licensed Product is
commercially sold in the first Major Market Country, and 3%
of Net Sales, on a quarterly basis, for each of the
following eight completed calendar quarters.
(b) In determining Product Payments,
Development Costs shall be determined as of the last day of
each calendar quarter, in order to determine the rates
payable with respect to Net Sales for the next calendar
quarter for all countries included in the Territory as of
the first day of such next calendar quarter, and for any
country added to the Territory during such next calendar
quarter.
(c) In determining Product Payments, Net Sales by
ALZA shall be reduced by the dollar amount of any license or
similar payments made by or due from ALZA or its Affiliates
to third parties with respect to sales of such Licensed
Product in the Territory. If license or similar payments
are made to third parties with respect to sales of both the
Licensed Product in the Territory and to sales of other
products, ALZA shall allocate such payments, if necessary,
in a commercially reasonable manner.
3.2 Term of Payments. The obligation to make
Product Payments hereunder shall continue until 15 years
after the date of the first commercial sale of the Licensed
Product in any Major Market Country, and shall terminate as
to all countries at the end of such 15-year period.
3.3 Buy-Out of Payments.
(a) ALZA shall have the option, in its
discretion, at any time after the end of the twelfth
calendar quarter during which the Licensed Product was
commercially sold in any country, to buy out its remaining
obligations to make Product Payments with respect to Net
Sales of such Licensed Product in such country. The buy out
price shall be an amount equal to 15 times the Product
Payments made by or due from ALZA to Crescendo with respect
to Net Sales of such Licensed Product in such country for
the four calendar quarters immediately preceding the quarter
in which the buy-out option is exercised, plus 15 times such
additional Product Payments as would have been made but for
the 2.5% and 3% limits set forth in Section 3.1 on Product
Payments for such period.
(b) ALZA shall have the option, in its
discretion, at any time after the end of the twelfth
calendar quarter during which the Licensed Product was
commercially sold in either the United States or two other
Major Market Countries, to buy out its remaining
obligations to make Product Payments with respect to Net
Sales of such Licensed Product in the Territory. The buy-
out price shall be an amount equal to (i) 20 times (A) the
Product Payments made by or due from ALZA to Crescendo for
such Licensed Product in the Territory, plus (B) such
payments as would have been made by or due from ALZA to
Crescendo if ALZA had not exercised any country-specific buy-
out option with respect to Net Sales of such Licensed
Product, plus (C) such additional Product Payments as would
have been made but for the 2.5% and 3% limits set forth in
Section 3.1 on Product Payments for such period, in each
case, for the four calendar quarters immediately preceding
the quarter in which the buy-out option is exercised, less
(ii) any amounts previously paid to exercise any country-
specific buy out option with respect to Net Sales of such
Licensed Product.
4. Accounting.
4.1 Reports. Within 90 days after the end of
each calendar quarter for which Product Payments are due,
ALZA shall render an accounting to Crescendo, on a country-
by-country basis, with respect to all Product Payments due
for such quarter. Such report shall indicate, for such
quarter, the quantity and dollar amount of Net Sales of the
Licensed Product by ALZA and its Affiliates, sublicensees,
distributors and marketing partners (and their Affiliates),
or other consideration with respect to Net Sales, with
respect to which payments are due; provided, however, that
if ALZA shall not have received from any sublicensee,
distributor or marketing partner a report of its (and its
Affiliates') sales for such quarter, then such sales shall
be included in the next quarterly report. In case no
Product Payments are due for any calendar quarter, ALZA
shall so report.
4.2 Records; Review by Accountants. ALZA shall
keep and maintain, in accordance with generally accepted
accounting principles, proper and complete records and books
of account documenting all amounts paid or payable by ALZA
to Crescendo. Crescendo shall have the right, once in each
calendar year during regular business hours and upon
reasonable notice to ALZA, at Crescendo's expense, to
examine or have examined by a certified public accountant or
similar person, such of the records of ALZA as may be
necessary to verify the accuracy of the reports and payments
made under this Agreement. Such examination shall take
place not later than two years following the year in
question, and only one examination may take place with
respect to any period as to which such books and records are
examined. ALZA shall obtain, for itself and for Crescendo,
similar reasonable rights to audit information pertaining to
Net Sales from each party appointed to commercialize any
product as to which payments are due to Crescendo hereunder.
5. Times and Currencies Of Payments.
5.1 Payments. Payments shown by each calendar
quarter report to have accrued shall be due and payable on
the date such report is due and shall be paid in United
States dollars. Any and all taxes due or payable on such
payments or with respect to the remittance thereof shall be
deducted from such payments and shall be paid by ALZA to the
proper taxing authorities, and proof of payment shall be
secured and sent to Crescendo as evidence of such payment.
The rate of exchange to be used in computing the amount of
the United States dollars due to Crescendo in satisfaction
of payment obligations with respect to sales in foreign
countries shall be calculated by converting the amount due
in such foreign currency into United States dollars at the
rate for the purchase of United States dollars with such
currency as published in The Wall Street Journal on the last
business day of the calendar quarter for which payment is
being made.
5.2 Certain Foreign Payments. If governmental
regulations prevent remittance from any foreign country of
any amounts due under Section 3.1 in respect of that
country, ALZA shall so notify Crescendo in writing, and the
obligation under this Agreement to make payments with
respect to sales in that country shall be suspended (but the
amounts due but not paid shall continue to accrue) until
such remittances are possible. Crescendo shall have the
right, upon written notice to ALZA, to receive payment in
any such country in the local currency.
5.3 Late Payments. Any payments due hereunder
that are not made when due shall bear interest at the lesser
of 10%
per annum or the maximum rate as may be allowed by law,
beginning on the date when Crescendo has notified ALZA that
such payments are overdue.
6. Patent Infringement.
6.1 Notice. Each party shall promptly notify the
other party of use or sale by a third party of an Infringing
Product.
6.2 Legal Action. If a third party manufactures
or sells an Infringing Product, ALZA may, at its own
expense, bring legal action to restrain such infringement
and for damages. Any recoveries resulting from any such
action shall be first applied to reimburse ALZA for its
expenses (including reasonable attorneys' fees) incurred in
bringing the action. Crescendo will be entitled to a share
of the remaining recoveries in the same percentage as the
percentage of Net Sales as to which Product Payments are due
to Crescendo during the period of the infringement or
alleged infringement. If (a) ALZA fails to take the
necessary steps to restrain such infringement or alleged
infringement by litigation or otherwise within 90 days after
either party's notice described in Section 6.1, (b) if the
infringement or alleged infringement occurs during a period
for which Crescendo is entitled to receive Product Payments
hereunder, and (c) if over a period of at least two calendar
quarters such Infringing Product achieves an annualized unit
sales volume in the country of infringement equal to 25% of
the annualized unit sales volume of the Licensed Product
sold by ALZA and its Affiliates, sublicensees, distributors
and marketing partners (and their Affiliates) in such
country during such year, then Crescendo may institute, in
its own name, at its own expense and with the right to all
recoveries, such litigation or other appropriate action as
it may deem appropriate to restrain such infringement,
provided that Crescendo has first given to ALZA 60 days
advance notice of its intention to take such action, and
provided further, that ALZA has not itself taken appropriate
action during such 60 day period.
6.3 Cooperation. If either party desires to
bring an action in accordance with Section 6.2, the other
party agrees to cooperate fully with the party bringing such
action in the pursuit thereof, at the expense of the party
bringing such action and to the extent reasonably requested
by such party. If the third party in any such action
brought by Crescendo brings a counteraction for invalidation
or misuse of a patent covering the Licensed Product,
Crescendo promptly shall notify ALZA and ALZA may, within
six months of the notification, join and participate in such
action at its own expense.
6.4 Settlement. Each party agrees not to settle
any action it brings in a manner that would adversely affect
the other party without the other party's prior written
approval.
7. Effective Date and Term.
7.1 Effective Date and Term. This Agreement will
become effective in accordance with Section 2.3 of the
License Option Agreement and, unless terminated in
accordance with any of the provisions hereof, shall remain
in full force and effect thereafter.
8. Indemnification.
8.1 Indemnity. ALZA shall indemnify, defend and
hold
Crescendo (and its Affiliates) harmless from and against any
and all liabilities, claims, demands, damages, costs,
expenses or money judgments incurred by or rendered against
Crescendo and its Affiliates, which arise out of the use,
design, labeling or manufacture, processing, packaging, sale
or commercialization of the Licensed Product by ALZA, its
Affiliates, subcontractors, sublicensees, distributors and
marketing partners (and their Affiliates). Crescendo shall
permit ALZA's attorneys, at ALZA's discretion and cost, to
control the defense of any claims or suits as to which
Crescendo may be entitled to indemnification hereunder, and
Crescendo agrees not to settle any such claims or suits
without the prior written consent of ALZA. Crescendo shall
have the right to participate, at its own expense, in the
defense of any such claim or demand to the extent it so
desires.
8.2 Notice. Crescendo shall give ALZA prompt
notice in writing, in the manner set forth in Section 11.7
below, of any claim or demand made against Crescendo for
which Crescendo may be entitled to indemnification under
Section 8.1.
9. Disclaimers.
CRESCENDO DISCLAIMS ANY EXPRESS OR IMPLIED WARRANTY (A)
THAT THE LICENSED PRODUCT OR ANY TECHNOLOGY INCORPORATED
THEREIN, OR THE MANUFACTURE, USE OR SALE THEREOF, WILL BE
FREE FROM CLAIMS OF PATENT INFRINGEMENT, INTERFERENCE OR
UNLAWFUL USE OF PROPRIETARY INFORMATION OF ANY THIRD PARTY
AND (B) OF THE ACCURACY, RELIABILITY, TECHNOLOGICAL OR
COMMERCIAL VALUE, COMPREHENSIVENESS OR MERCHANTABILITY OF
THE LICENSED PRODUCT OR ANY TECHNOLOGY INCORPORATED THEREIN
OR THEIR SUITABILITY OR FITNESS FOR ANY PURPOSE WHATSOEVER
INCLUDING, WITHOUT LIMITATION, THE DESIGN, DEVELOPMENT,
MANUFACTURE, USE OR SALE OF THE LICENSED PRODUCT. CRESCENDO
DISCLAIMS ALL OTHER WARRANTIES OF WHATEVER NATURE, EXPRESS
OR IMPLIED.
10. Termination.
10.1 Termination by Crescendo. Crescendo may, in
its discretion, terminate this Agreement in the event that
ALZA:
(a) breaches any of its material
obligations hereunder and such breach continues for a period
of 60 days after written notice thereof; or
(b) enters into any proceeding, whether
voluntary or otherwise, in bankruptcy, reorganization or
arrangement for the appointment of a receiver or trustee to
take possession of ALZA's assets or any other proceedings
under any law for the relief of creditors or makes an
assignment for the benefit of its creditors.
10.2 Termination by ALZA. ALZA may terminate this
Agreement with respect to one or more countries included in
the Territory upon 30 days' prior written notice to
Crescendo if ALZA elects for any reason to discontinue
commercialization of the Licensed Product in such country.
10.3 Consequences of Termination. Termination of
this Agreement for any reason in accordance with the terms
hereof shall be without prejudice to:
(a) Crescendo's right to receive all
payments accrued under Section 3 prior to the effective date
of such termination; and
(b) any other remedies which either
party may then or thereafter have hereunder or otherwise.
If this Agreement terminates pursuant to this Section 10,
ALZA shall immediately discontinue any promotion and sales
of the Licensed Product. Notwithstanding the foregoing, in
the event of any termination under this Section 10, ALZA may
sell its inventory in stock on the date of termination for a
period of up to six months after the termination, and shall
remit payments to Crescendo in respect thereto in accordance
with this Agreement.
11. Miscellaneous.
11.1 Waiver, Remedies and Amendment. Any waiver
by either party hereto of a breach of any provisions of this
Agreement shall not be implied and shall not be valid unless
such waiver is recited in writing and signed by such party.
Failure of any party to require, in one or more instances,
performance by the other party in strict accordance with the
terms and conditions of this Agreement shall not be deemed a
waiver or relinquishment of the future performance of any
such terms or conditions or of any other terms and
conditions of this Agreement. A waiver by either party of
any term or condition of this Agreement shall not be deemed
or construed to be a waiver of such term or condition for
any other term. All rights, remedies, undertakings,
obligations and agreements contained in this Agreement shall
be cumulative and none of them shall be a limitation of any
other remedy, right, undertaking, obligation or agreement of
either party. This Agreement may not be amended except in a
writing signed by both parties.
11.2 Assignment. Neither party may assign its
rights and obligations hereunder without the prior written
consent of the other party, which consent may not be
unreasonably withheld; provided, however, that ALZA may
assign such rights and obligations hereunder to an Affiliate
of ALZA or to any person or entity with which ALZA is merged
or consolidated or which acquires all or substantially all
of the assets of ALZA.
11.3 Arbitration.
(a) All disputes which may arise under, out
of or in connection with this Agreement shall be settled by
arbitration conducted in the City of San Francisco, State of
California, in accordance with the then existing rules of
the American Arbitration Association, and judgment upon the
award rendered by the Arbitrators may be entered in any
court having jurisdiction thereof. The parties hereby agree
that service of any notices in the course of such
arbitration at their respective addresses as provided for in
Section 11.7 of this Agreement shall be valid and
sufficient.
(b) In any arbitration pursuant to this
Section 11.3, the award shall be rendered by a majority of
the members of a board of arbitration consisting of three
members who shall be appointed by the parties jointly, or if
the parties cannot agree as to three arbitrators within 30
days after the commencement of the arbitration proceeding,
then one arbitrator shall be appointed by ALZA and one
arbitrator shall be appointed by Crescendo within 60 days
after the commencement of the arbitration proceeding. The
third arbitrator shall be appointed by mutual agreement of
such two arbitrators. In the event of failure of the two
arbitrators to agree within 75 days after commencement of
the arbitration proceeding upon the appointment of the third
arbitrator, the third arbitrator shall be appointed by the
American Arbitration Association in accordance with its then
existing rules. Notwithstanding the foregoing, in the event
that any party shall fail to appoint an arbitrator it is
required to appoint within the specified time period, such
arbitrator and the third arbitrator shall be appointed by
the American Arbitration Association in accordance with its
then existing rules. For purposes of this Section 11.3, the
"commencement of the arbitration proceeding" shall be deemed
to be the date upon which a written demand for arbitration
is received by the American Arbitration Association from one
of the parties.
11.4 Counterparts. This Agreement may be executed
in any number of counterparts, each of which when so
executed shall be deemed to be an original and all of which
when taken together shall constitute this Agreement.
11.5 Governing Law. This Agreement shall be
governed by and construed in accordance with the laws of the
state of California as applied to residents of that state
entering into contracts to be performed in that state.
11.6 Headings. The headings set forth at the
beginning of the various sections of this Agreement are for
convenience and form no part of the Agreement between the
parties.
11.7 Notices. Notices required under this
Agreement shall be in writing and sent by registered or
certified mail, postage prepaid, or by facsimile and
confirmed by registered or certified mail, postage prepaid,
and addressed as follows:
If to ALZA: ALZA Corporation
▇▇▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇
Facsimile: (▇▇▇) ▇▇▇-▇▇▇▇
Attention: Senior Vice President
and General Counsel
If to Crescendo: Crescendo Pharmaceuticals Corporation
▇▇▇▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇▇
▇▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇
Facsimile: (▇▇▇) ▇▇▇-▇▇▇▇
Attention: President and
Chief Executive Officer
All notices shall be deemed to be effective five days
after the date of mailing or upon receipt if sent by
facsimile (but only if followed by certified or registered
confirmation). Either party may change the address at which
notice is to be received by written notice pursuant to this
Section 11.7.
11.8 Severability. If any provision of this
Agreement is held by a court of competent jurisdiction to be
invalid or unenforceable, it shall be modified, if possible,
to the minimum extent necessary to make it valid and
enforceable or, if such modification is not possible, it
shall be stricken and the remaining provisions shall remain
in full force and effect.
11.9 Relationship of the Parties. For all
purposes of this Agreement, Crescendo and ALZA shall be
deemed to be independent contractors and anything in this
Agreement to the contrary notwithstanding, nothing herein
shall be deemed to constitute Crescendo and ALZA as
partners, joint venturers, coowners, an association or any
entity separate and apart from each
party itself, nor shall this Agreement constitute any party
hereto an employee or agent, legal or otherwise, of the
other party for any purposes whatsoever. Neither party
hereto is authorized to make any statements or
representations on behalf of the other party or in any way
to obligate the other party, except as expressly authorized
in writing by the other party. Anything in this Agreement to
the contrary notwithstanding, no party hereto shall assume
nor shall be liable for any liabilities or obligations of
the other party, whether past, present or future.
11.10 Survival. The provisions of Sections 1,
4.2, 8, 9, 10.3, 11.1, 11.3, 11.5, 11.6, 11.7, 11.8, 11.9,
and this Section 11.10 shall survive the termination for any
reason of this Agreement. Any payments due under this
Agreement with respect to any period prior to its
termination shall be made notwithstanding the termination of
this Agreement. Neither party shall be liable to the other
due to the termination of this Agreement as provided herein,
whether in loss of good will, anticipated profits or
otherwise.
11.11 Force Majeure. Neither party to this
Agreement shall be liable for failure or delay in the
performance of any of its obligations hereunder, if such
failure or delay is due to causes beyond its reasonable
control including, without limitation, acts of God,
earthquakes, fires, strikes, acts of war, or intervention of
any governmental authority, but any such delay or failure
shall be remedied by such party as soon as possible after
the removal of the cause of such failure or delay.
IN WITNESS WHEREOF, the parties have executed this
Agreement on the date first set forth above.
ALZA CORPORATION
By: /s/ ▇▇▇▇▇ ▇. Staple
Title: Senior Vice President
and General Counsel
CRESCENDO PHARMACEUTICALS CORPORATION
By: /s/ ▇▇. ▇▇▇▇▇ ▇. ▇▇▇▇▇
Title: President and
Chief Executive Officer
ATTACHMENT A
LICENSED PRODUCT
ATTACHMENT B
TERRITORY
DATE OF EXERCISE
COUNTRY