This License Agreement (the "Agreement") is made this 16th
day of December, 1998 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 Attachment 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
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 Attachment 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 in 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 proceeding 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 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
000 Xxxx Xxxx Xxxx
Xxxx Xxxx, XX 00000
Facsimile: (000) 000-0000
Attention: Senior Vice President and
General Counsel
If to Crescendo: Crescendo Pharmaceuticals
Corporation
0000 Xxxx Xxxx Xxxx
Xxxx Xxxx, XX 00000
Facsimile: (000) 000-0000
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, 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 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/ Xxxxx X.Staple
Title: Sr. Vice President, General
Counsel and Assistant Secretary
CRESCENDO PHARMACEUTICALS CORPORATION
By: _/s/_Dr. Xxxx X. Xxxx
Title: President & Chief Executive
Officer
ATTACHMENT A
LICENSED PRODUCT
XXXX-registered trademark- oxybutynin (referred to as CPC-1)
ATTACHMENT B
TERRITORY
DATE OF EXERCISE COUNTRY
December 16, 1998 worldwide
