EXHIBIT 10.3
DEVELOPMENT AGREEMENT
This Development Agreement (the "Agreement") is made as
of the 5th day of September, 1997 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 below)
and commercializing such products, most likely through
licensing to ALZA.
B. ALZA is engaged in the business of performing
research and development directed toward the development and
commercialization of pharmaceutical products.
C. Crescendo desires that ALZA perform, on behalf of
Crescendo, research and development activities directed
toward the selection and development of Crescendo Products
(as defined below) and related activities.
Now, therefore, the parties agree as follows:
1. Definitions.
For the 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 "ALZA Technology" shall mean all Proprietary
Rights, whether patented or unpatented, owned by, licensed
to or controlled by ALZA, as of the date of this Agreement
or during the term of this Agreement, including the
Developed Technology and the Identified Product Technology.
1.3 "Available Funds" shall mean, as of any date
of determination, $300 million contributed to Crescendo by
ALZA on or about September 30, 1997, plus any investment
income earned thereon, less (a) Crescendo's reasonable
ongoing administrative expenses, (b) the Technology Fee and
(c) reserves of up to $2 million.
1.4 "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
this Agreement.
1.5 "Developed Technology" shall mean Proprietary
Rights that (a) are first generated, conceived or reduced to
practice, as the case may be, by ALZA or by any third party
in the course of performing activities undertaken pursuant
to this Agreement or (b) are, in any manner, acquired by, or
otherwise obtained on behalf of, Crescendo during the term
of this Agreement from persons other than ALZA and are
necessary or useful to the selection, development or
commercialization of Crescendo Products or Technical
Evaluation Products.
1.6 "Developed Technology Product" shall mean any
product (other than a Crescendo Product) (i) covered, at the
time of sale in a country by one or more unexpired patents
issued in such country that are included in Developed
Technology and (ii) with respect to which ALZA receives any
consideration.
1.7 "Developed Technology Royalties" shall mean
the payments made by ALZA to Crescendo with respect to Net
Sales of Developed Technology Products.
1.8 "Development Costs" shall mean the cost of
the activities undertaken pursuant to this Agreement,
determined in accordance with Exhibit A hereto.
1.9 "Distribution" shall mean ALZA's distribution
of all of the outstanding shares of Class A Common Stock of
Crescendo to ALZA stockholders and debenture holders of
record on September 18, 1997.
1.10 "Distribution Agreement" shall mean the
Distribution Agreement dated as of the date hereof between
ALZA and Crescendo.
1.11 "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.
1.12 "Identified Product Technology" shall mean
all ALZA Technology existing on the date of the closing of
ALZA's purchase of the outstanding shares of Therapeutic
Discovery Corporation relating to any Identified Product.
1.13 "Identified Products" shall mean, upon the
closing of ALZA's purchase of the outstanding shares of
Therapeutic Discovery Corporation, the following products:
OROSr oxybutynin, XXXXXX leuprolide, OROSr methylphenidate,
IUTS progesterone, D-TRANST testosterone matrix, E-TRANST
LHRH and E-TRANST (skin interface technology) insulin.
1.14 "License Option" shall mean the option
granted to ALZA, pursuant to the License Option Agreement.
1.15 "License Option Agreement" shall mean the
License Option Agreement dated as of the date hereof between
ALZA and Crescendo.
1.16 "Major Market Country" shall mean any of the
following
countries: United States, France, Germany, Italy, Japan or
the
United Kingdom.
1.17 "Net Sales" shall mean the total amount
invoiced in United States dollars (or converted thereto in
accordance with Section 7.6 hereof) on sales of a 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 product in question 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 product to unrelated third parties
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 product to unrelated third
parties, in each case whether such consideration is in cash,
payment in kind, exchange or other form.
1.18 "Product Candidate" shall mean a potential
Crescendo Product for which ALZA proposes a Work Plan in accordance with
Section 2.2.
1.19 "Product Development Program" shall mean a
program to develop a Crescendo Product.
1.20 "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.
1.21 "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.
1.22 "Technical Evaluation" shall mean a limited
technical evaluation involving a proprietary Therapeutic
Agent of a third party undertaken in order to determine the
suitability of such Therapeutic Agent in an ALZA drug
delivery system or to induce the third party to license the
Therapeutic Agent to ALZA or Crescendo or otherwise
collaborate with ALZA and Crescendo in the development of a
product.
1.23 "Technical Evaluation Product" shall mean a
product, other than one which will become a Crescendo
Product, for which
Crescendo funds a Technical Evaluation.
1.24 "Technical Evaluation Product Payments" shall
mean the payments made by ALZA to Crescendo pursuant to
Section 7.4 with respect to Net Sales of Technical
Evaluation Products.
1.25 "Technology Fee" shall mean payments to be
made over a maximum period of three years by Crescendo to
ALZA in exchange for ALZA granting Crescendo a license to
use the Identified Product Technology.
1.26 "Technology License Agreement" shall mean the
Technology License Agreement dated as of the date hereof
between ALZA and Crescendo.
1.27 "Therapeutic Agent" shall mean a drug,
protein, peptide, gene, compound or other pharmaceutically
active ingredient.
1.28 "TDC" shall mean Therapeutic Discovery
Corporation.
1.29 "Work Plan" shall mean a work plan including
a cost estimate.
2. Product Development Program.
2.1 Product Candidate Identification Process.
Within 30 days after the date of the Distribution and at
least annually thereafter, ALZA shall provide Crescendo with
a proposed Work Plan covering activities to be undertaken by
ALZA to search for and identify Product Candidates for
consideration by Crescendo under Section 2.2 and to
identify potential Technical Evaluations for consideration
by Crescendo under Section 2.4. Promptly after ALZA
provides Crescendo with such proposed Work Plan, Crescendo
shall notify ALZA of its acceptance or rejection of such
proposed Work Plan.
2.2 Product Candidate Selection.
(a) From time to time during the term of
this Agreement, ALZA shall present Crescendo with Product
Candidates recommended by ALZA for development as Crescendo
Products, together with preliminary lifetime plans that
provide, for each such Product Candidate, an estimate of the
total Development Costs for the Product Development Program
for such Product Candidate through FDA review for clearance
to market the resulting product, milestones (including the
timetable for the development of the resulting product),
detailed Work Plans for the first proposed stage of the
Product Development Program and any other factors that ALZA
deemed appropriate to determine whether to recommend the
Product Candidate for development.
(b) Promptly after ALZA recommends a Product
Candidate for development to Crescendo, Crescendo shall
notify ALZA in writing of its acceptance (in whole or in
part) or rejection (in whole or in part) of the initial Work
Plan included with such recommendation. Upon written
acceptance (in whole or in part) of a Work Plan for a
Product Candidate under this Section 2.2, such Product
Candidate shall be deemed to be a Crescendo Product.
(c) If Crescendo fails to accept a
recommended Product Candidate for development as a Crescendo
Product within 120 days of recommendation by ALZA, then
Crescendo shall have no rights with respect to such Product
Candidate; provided, however, that, at any time during the
term of this Agreement, Crescendo may request ALZA to
perform a Product Development Program for such Product
Candidate and ALZA shall undertake its duties with respect
to such Product Development Program, all in accordance with
this Section 2 and Section 3, unless, at the time of such
request, ALZA is then undertaking the development of such
Product Candidate for its own account or with a third party,
or ALZA is otherwise not permitted to undertake such
development hereunder because of an arrangement with a third
party.
2.3 Identified Products. As set forth in Section
4.1, Crescendo shall fund the Development Costs under ALZA-
approved Work Plans for each of the Identified Products
during the period from the date on which TDC ceased funding
such products through October 31, 1997. On or before
October 10, 1997, ALZA shall provide Crescendo with a
proposed Work Plan and a lifetime plan for the continued
development of each of the Identified Products. On or before
October 31, 1997, Crescendo shall notify ALZA in writing of
its acceptance (in whole or in part) or rejection (in whole
or in part) thereof.
2.4 Technical Evaluations. From time to time
during the term of this Agreement, ALZA may provide
Crescendo with a proposed Work Plan covering one or more
Technical Evaluations with respect to potential Technical
Evaluation Products. Promptly after ALZA provides Crescendo
with such proposed Work Plan, Crescendo shall notify ALZA of
its acceptance (in whole or in part) or rejection (in whole
or in part) of such proposed Work Plan. ALZA may propose to
Crescendo at any time that any Technical Evaluation Product
become a Crescendo Product by complying with the procedures
set forth in Section 2.2.
2.5 Partial Acceptance. If Crescendo accepts or
rejects a Work Plan in part, ALZA may either (i) perform the
activities under the Work Plan as approved by Crescendo or
(ii) propose a modified Work Plan to Crescendo for approval.
3. Research and Development Programs; ALZA Services.
3.1 Product Development - Crescendo Obligations.
Once Crescendo accepts a Work Plan for a Crescendo Product
or a Technical Evaluation pursuant to Section 2.2 or 2.4,
Crescendo shall use diligent efforts to complete such Work
Plan, as amended from time to time. Crescendo shall request
that ALZA or a third party perform the activities under each
such Work Plan; provided, however, that ALZA's prior written
consent shall be required for a third party to perform any
activities that involve ALZA Technology or that could affect
ALZA's rights under any agreement between ALZA and Crescendo
or ALZA's rights as holder of the Class B Common Stock of
Crescendo. Crescendo shall use diligent efforts to cause
each third party other than ALZA (or a third party engaged
by ALZA) to perform diligently the activities assigned it
under a Work Plan.
3.2 Product Development - ALZA Obligations; Other
ALZA Activities. Crescendo hereby engages ALZA to perform
product identification, evaluation, research, development
and related activities in accordance with the tasks assigned
to ALZA under the Work Plans accepted under Section 2, and
to undertake such other activities as the parties may agree.
ALZA diligently shall perform or cause to be performed such
activities. In connection therewith, ALZA shall make
available such of its scientific, engineering, manufacturing
and other personnel, and shall take such steps as it deems
necessary in order to perform its obligations in accordance
with the terms hereof, but ALZA is not obligated to devote
any specific amount of time or resources to activities
hereunder. ALZA shall have full discretion to determine
from time to time the allocation of resources of ALZA
(facilities, equipment and personnel) that are available for
activities hereunder, and to determine from time to time the
allocation of resources of ALZA among such activities.
Crescendo understands, acknowledges and agrees that ALZA may
devote substantial time and resources to research and
development activities for other persons and for its own
account, and as a result, ALZA may develop and
commercialize, or have commercialized, products competitive
with Crescendo Products, Technical Evaluation Products and
Developed Technology Products.
3.3 Work Plans. The parties understand and
acknowledge that it is difficult to predict accurately the
activities that will be necessary to complete any Work Plan,
including the Development Costs thereof, and that
significant uncertainties exist in any product development
effort. Crescendo and ALZA shall cooperate in good faith to
devise mutually acceptable Work Plans for Product
Development Programs, Technical Evaluations, candidate
identification activities and such other activities as the
parties may agree. ALZA and Crescendo shall review each
such Work Plan from time to time, and with respect to a Work
Plan for a Crescendo Product no less often than at the end
of each stage of development, and shall revise each Work
Plan as appropriate such that each Work Plan remains a best
estimate of the work to be performed to complete the
development objectives identified therein and of the
Development Costs thereunder. Crescendo shall not be
obligated to pay Development Costs in excess of those
provided for in approved Work Plans, and ALZA shall not be
obligated to perform work which would result in Development
Costs exceeding those in approved Work Plans.
3.4 Consultation. Crescendo shall consult with
ALZA and shall review with ALZA from time to time the
progress toward completion of the activities under the Work
Plans for candidate identification activities and for each
Crescendo Product and Technical Evaluation, including
without limitation, the status in each country for each
Crescendo Product for which marketing clearance is being
sought.
3.5 Third Party Rights. Subject to the terms and
conditions of this Agreement, Crescendo shall have
discretion to attempt to obtain, using Available Funds, any
Proprietary Rights from any third party that Crescendo
reasonably determines to be necessary or useful to conduct
any Product Development Program, Technical Evaluation or
related activities under this Agreement. Such Proprietary
Rights shall be included in the Developed Technology. The
costs of obtaining any such Proprietary Rights shall be
included in the calculation of Development Costs paid by
Crescendo pursuant to this Agreement.
3.6 Development Assets. ALZA shall own and have
the right to use any clinical supplies, materials and other
assets purchased, manufactured or developed pursuant to
approved Work Plans ("Development Assets") and, until such
time as the License Option is exercised with respect to the
product to which any particular Development Asset pertains,
shall use such Development Assets solely in the development
of Crescendo Products under approved Work Plans.
3.7 No Use of Available Funds After Expiration of
License Option. After such time as the License Option for a
Crescendo Product in a country expires unexercised as to
such country, no additional Available Funds shall be
expended for the development of such Crescendo Product for
sale in such country.
3.8 Notices. ALZA shall notify Crescendo within
three business days after ALZA receives notice of clearance
to market any Crescendo Product in any country. ALZA shall
promptly notify Crescendo of the first commercial sale of a
Crescendo Product, Developed Technology Product or Technical
Evaluation Product in any country.
4. Payment For Services; Timing of Payments.
4.1 Payment of Development Costs. In
consideration of the work to be carried out by ALZA
hereunder, Crescendo shall reimburse ALZA for all
Development Costs incurred by ALZA in accordance with
accepted Work Plans. Crescendo shall also reimburse ALZA
for Development Costs incurred with respect to the
Identified Products from the date on which TDC ceased
funding the development of such products through October 31,
1997 in accordance with the ALZA-approved Work Plans for
such products in effect as of the date hereof.
4.2 Timing of Payments. Crescendo shall pay to
ALZA monthly, in arrears, all such Development Costs
incurred by ALZA during the preceding calendar month, within
30 days after ALZA's invoice therefor.
4.3 Sufficiency of Funds. Neither Crescendo nor
ALZA makes any warranty, express or implied, that Available
Funds will be sufficient to complete the development of any
or all Crescendo Products or the other activities
contemplated hereunder.
5. Reports and Records.
5.1 Product Development Program Reports. Within
45 days after the end of each calendar quarter, ALZA shall
provide to Crescendo, and Crescendo shall require each third
party engaged by Crescendo pursuant to Section 3.1 to
provide to Crescendo and to ALZA, a reasonably detailed
report setting forth (a) a summary of the work performed
hereunder by ALZA or such third party, as appropriate, and
its employees and agents during such quarter; and (b) the
total Development Costs of such activities during such
quarter and cumulatively to date, for each Work Plan.
5.2 Available Funds Statement. Within 45 days
after the end of each calendar quarter, Crescendo shall
provide to ALZA a statement setting forth, as of the end of
such quarter, the Available Funds remaining.
5.3 Product Payment Reports. Within 90 days
after the end of each calendar quarter for which payments
are due under Section 7.4, ALZA shall render an accounting
to Crescendo, on a productby-product and country-by-country
basis, with respect to all payments due for such quarter
under Section 7.4. Such report shall indicate, for such
quarter, the quantity and dollar amount of Net Sales of each
Developed Technology Product and each Technical Evaluation
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 foreign
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, and
payments with respect to such report shall be due in the
next quarter. In case no payment is due for any calendar
quarter, ALZA shall so report. ALZA shall keep accurate
records in sufficient detail to enable the payments due
hereunder to be determined.
5.4 Records; Review by Accountants. Each of
Crescendo and ALZA shall keep and maintain, in accordance
with generally accepted accounting principles, proper and
complete records and books of account documenting all
Development Costs and amounts paid or payable by ALZA to
Crescendo under this Agreement, in the case of ALZA, and
remaining Available Funds, in the case of Crescendo. Each of
Crescendo and ALZA shall have the right, once in each
calendar year during regular business hours and upon
reasonable notice to the other party, and at its own
expense, to examine or to have examined by a certified
public accountant or similar person reasonably acceptable to
the other party, pertinent books and records of one another,
for the sole purpose of determining the correctness of
amounts invoiced, paid or due under this Agreement and the
application of Available Funds by Crescendo. 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. Each party shall obtain, for
itself and for the other party, similar reasonable rights to
audit the Development Costs of, and payments with respect to
Net Sales by, each third party engaged by Crescendo pursuant
to Section 3.1 or appointed or permitted by ALZA to
commercialize any product as to which payments are due to
Crescendo hereunder.
6. Technology Licensed For Development.
6.1 License to Use ALZA Technology. Crescendo
hereby grants to ALZA a sublicense to use the ALZA
Technology licensed to Crescendo under the Technology
License Agreement solely for the purpose of conducting the
activities contemplated hereunder.
6.2 Termination of License. Termination of the
license granted under the Technology License Agreement
automatically shall terminate the sublicense to the ALZA
Technology granted to ALZA pursuant to Section 6.1.
7. Ownership of Crescendo Products and Developed
Technology Patents; Payments to Crescendo.
7.1 Ownership of Crescendo Products. Unless
Crescendo agrees otherwise, all Crescendo Products will be
owned by Crescendo or, in the case of a product licensed
from a third party (or a product incorporating a Therapeutic
Agent licensed from a third party), exclusively licensed to
Crescendo on a worldwide basis, with the right to
sublicense, and otherwise on terms granting rights
substantially similar to those rights Crescendo would have
as an owner, in either case subject to the License Option.
7.2 Ownership of Developed Technology. As
between ALZA and Crescendo, ALZA shall own all Developed
Technology (which shall be part of the ALZA Technology),
subject to the Technology License Agreement.
7.3 Patents Covering Developed Technology. ALZA
shall determine whether and to what extent to seek and
maintain United States and/or foreign patents covering any
Developed Technology. Any such patents and applications
therefor shall be in ALZA's name and shall be owned by ALZA.
Crescendo and ALZA each shall pay one-half of the costs of
obtaining and maintaining any such patents during the term
of this Agreement.
7.4 Payments Based on Sales of Developed
Technology Products and Technical Evaluation Products.
(a) ALZA shall pay Developed Technology
Royalties to Crescendo, on a country-by-country basis, equal
to 1% of Net Sales in the relevant country of each Developed
Technology Product. Only one payment under this Section 7.4
shall be payable by ALZA to Crescendo with respect to Net
Sales of each Developed Technology Product in any country,
regardless of the number of patents covering such Developed
Technology Product in such country. Subject to Section 7.5,
payments with respect to sales of a Developed Technology
Product in any country shall be made by ALZA until the
expiration of the last to expire of the patent or patents
covering such Developed Technology Product in any country.
(b) ALZA shall make Technical Evaluation
Product Payments to Crescendo equal to 1% of Net Sales of
each Technical Evaluation Product. Subject to Section 7.5,
payments with respect to sales of a Technical Evaluation
Product shall be made by ALZA until seven years after the
first commercial sale of such Technical Evaluation Product
in the first Major Market Country in which such product is
commercially sold.
(c) In determining payments due under this
Section 7.4, 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 any such sales of such Developed Technology
Product or Technical Evaluation Product. If license or
similar payments are made to third parties with respect to
sales of such products and to sales of other products, ALZA
shall allocate such payments, if necessary, in a
commercially reasonable manner.
(d) Notwithstanding the foregoing, if a
product is both a Developed Technology Product and a
Technical Evaluation Product, amounts payable under this
Section 7.4 with respect to such product for any period of
time shall be limited to 1% of Net Sales.
7.5 Buy-Out of Payments Based on Sales of
Developed Technology Products and Technical Evaluation
Products.
(a) ALZA shall have the option with respect
to each Developed Technology Product and each Technical
Evaluation Product, in its discretion, at any time after the
end of the twelfth calendar quarter during which such
product was commercially sold in a country, to buy out its
remaining obligation to make payments under Section 7.4
with respect to sales of such Developed Technology Product
or Technical Evaluation Product in such country. The buy-
out price shall be an amount equal to 15 times the payments
made by or due from ALZA to Crescendo under Section 7.4 with
respect to sales of such Developed Technology Product or
Technical Evaluation Product in such country for the four
calendar quarters immediately preceding the quarter in which
the buy-out option is exercised.
(b) ALZA shall have the option with respect
to each Developed Technology Product and each Technical
Evaluation Product, in its discretion, at any time after the
end of the twelfth calendar quarter during which such
product was commercially sold in either the United States or
two other Major Market Countries, to buy out its remaining
worldwide obligations to make payments under Section 7.4
with respect to sales of such Developed Technology Product
or Technical Evaluation Product. The buy-out price shall be
an amount equal to (i) 20 times (A) the payments made by or
due from ALZA to Crescendo under Section 7.4 with respect to
sales of such Developed Technology Product or Technical
Evaluation Product, 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 such Developed Technology Product or Technical Evaluation
Product, 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 buyout option with respect
to such Developed Technology Product or Technical Evaluation
Product.
7.6 Payments. Payments shown by each calendar
quarter report described in Section 5.3 to have accrued
shall be due and payable on the date the 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 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 based on 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.
7.7 Certain Foreign Payments. If governmental
regulations prevent remittance from any foreign country of
any amounts due under Section 7.4 with respect to 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.
7.8 Late Payments. Any payments due hereunder
that are not made when due shall accrue interest at the
lesser of 10% per annum or the maximum rate as may be
allowed by law, beginning on the date when Crescendo
notifies ALZA that such payments are overdue.
8. Access to Information; Confidentiality.
8.1 Access. Subject to the terms of this
Agreement, each party shall be permitted access to the
premises of the other during normal business hours, for the
purpose of monitoring the progress of activities under this
Agreement. Each party shall keep full and complete records
and notebooks containing all experiments performed during
its work under this Agreement and the results thereof. Such
items and copies of all documentation shall be available
during normal business hours for inspection by the other
party. In addition, each party shall provide to the other
such other information as reasonably may be requested.
8.2 Third Parties. Crescendo and ALZA shall
cause each third party engaged pursuant to Section 3.1 or
3.2 to provide access similar to that to be provided
pursuant to Section 8.1, for the benefit of both Crescendo
and ALZA.
8.3 Product Lists. ALZA shall maintain a
complete list of Crescendo Products, Developed Technology
Products and Technical Evaluation Products at all times.
Confirmation of the completeness and accuracy of such list
shall be made at any time upon the reasonable request of
Crescendo.
8.4 Confidentiality. During the term of this
Agreement and for a period of ten years following its
termination, each party shall maintain in confidence all
Proprietary Rights of the other; provided, however, that
nothing contained herein shall prevent either party from
disclosing any Proprietary Rights to the extent that such
Proprietary Rights (a) are required to be disclosed in
connection with selecting and developing Crescendo Products,
conducting Technical Evaluations, conducting related
activities, securing necessary governmental authorization
for the marketing of Crescendo Products, or directly or
indirectly making, using or selling Crescendo Products, as
permitted or provided for in the agreements between the
parties, (b) are required to be disclosed by law for the
purpose of complying with governmental regulations, (c) are
disclosed to sublicensees, distributors or marketing
partners or potential sublicenses, distributors or marketing
partners permitted under the agreements between the parties
in connection with the proposed or actual development,
manufacturing or marketing of Crescendo Products, subject to
similar obligations of confidentiality on the part of such
third parties as required by the agreements between the
parties, (d) are known to or used by the recipient prior to
the date hereof (other than through disclosure by or on
behalf of the other party) as evidenced by the recipient's
written records , (e) are lawfully disclosed to the
recipient by a third party having the right to disclose such
information to the recipient, or (f) either before or after
the time of disclosure to the recipient, become known to the
public other than by an unauthorized act or omission of the
recipient or any of the recipient's employees or agents;
provided that clause (d) does not give ALZA the right to
disclose Proprietary Rights that relate exclusively to the
Identified Products; provided further that, Crescendo may
disclose ALZA Proprietary Rights to third parties only in
accordance with the provisions of Section 10.3 hereof and in
accordance with the provisions of the Technology License
Agreement. The obligations of each of the parties pursuant
to this Section 8.4 shall survive the termination of this
Agreement for any reason. Any breach of this Section 8.4
may result in irreparable harm, and in the event of a
breach, the aggrieved party shall be entitled to seek
injunctive relief (without the need to post a bond) in
addition to any other remedies available at law or in
equity.
9. Public Disclosure.
9.1 Public Disclosure. The parties will work
together with respect to public statements disclosing the
status of and results under Product Development Programs and
related matters. Except to the extent previously disclosed
pursuant to the terms hereof, neither party shall disclose
to third parties nor originate any publicity, news release
or public announcement, written or oral, whether to the
public, the press, stockholders or otherwise, referring to
activities conducted, or the parties' performance under,
this Agreement, except such announcements, as in the opinion
of the counsel for the party making such announcement, are
required by law, including United States securities laws,
rules or regulations, without the prior written consent of
the other party. If a party decides to make an announcement
it believes to be required by law with respect to this
Agreement, it will give the other party such notice as is
reasonably practicable and an opportunity to comment upon
the announcement.
10. Covenants.
10.1 Use of Available Funds. Unless ALZA agrees
otherwise, Crescendo agrees to expend all Available Funds
for activities undertaken pursuant to this Agreement.
Pending application of all Available Funds as set forth
above, Available Funds shall be invested in securities
issued or guaranteed as to principal and interest by the
United States, or by a person controlled or supervised by or
acting as an instrumentality of the government of the United
States pursuant to authority granted by the Congress of the
United States, or any certificate of deposit for any of the
foregoing, or any other types of high quality marketable
investment securities that are proposed by Crescendo and are
approved by ALZA in its sole discretion.
10.2 Negative Pledge. Crescendo shall not create,
incur, assume or suffer to exist any lien upon or with
respect to, or otherwise take any action with respect to,
Available Funds so as to prevent or interfere with full
expenditure of such funds for activities under this
Agreement in accordance with Section 10.1.
10.3 No Inconsistent Agreements. Without the
written consent of ALZA, Crescendo shall not enter into any
agreement or arrangement that is in any way inconsistent
with or that could adversely affect ALZA Technology or
ALZA's rights under any agreement between ALZA and
Crescendo, or that is in any way inconsistent with or that
could adversely affect ALZA's rights as holder of the Class
B Common Stock of Crescendo. Crescendo must include in any
agreement between Crescendo and a third party relating to
Crescendo Products and/or activities hereunder such
provisions as ALZA reasonably deems appropriate to protect
ALZA Technology and to protect ALZA's rights under any
agreement between ALZA and Crescendo and as a holder of the
Class B Common Stock of Crescendo (including ALZA's rights
under the Purchase Option).
11. Effective Date; Term and Termination.
11.1 Effective Date. The effective date of this
Agreement shall be the date of the Distribution.
11.2 Automatic Termination. This Agreement shall
terminate upon exercise or expiration of the Purchase
Option, except that ALZA's obligations to make payments to
Crescendo with respect to Developed Technology Products and
Technical Evaluation Products shall continue after
expiration of the Purchase Option as provided in Section 7
hereof.
11.3 Other Termination. Either party may, in its
discretion, terminate this Agreement in the event that the
other party:
(a) breaches any material obligation
hereunder or under the Technology License Agreement, the
License Option Agreement, or any license thereunder, and
such breach continues for a period of 60 days after written
notice thereof by the terminating party to the other party;
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 its assets or any other proceeding under
any law for the relief of creditors, or makes an assignment
for the benefit of its creditors.
12. Force Majeure.
12.1 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.
13. Miscellaneous.
13.1 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 any other term or condition
of this Agreement. 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.
13.2 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.
13.3 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 13.7 of this Agreement shall be valid and
sufficient.
(b) In any arbitration pursuant to this
Section 13.3, 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 13.3, 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.
13.4 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.
13.5 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.
13.6 Headings. The section headings contained in
sections of this Agreement are included for convenience only
and form no part of the Agreement between the parties.
13.7 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 13.7.
13.8 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.
13.9 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
or be liable for any liabilities or obligations of the other
party, whether past, present or future.
13.10 Survival. The provisions of Sections 1, 7,
8.3, 8.4, 11, 13.1, 13.3, 13.5, 13.6, 13.7, 13.8, 13.9, and
this Section 13.10, and of Sections 4 and 5 to the extent of
obligations under such sections relating to periods prior to
termination of this Agreement, 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 hereto have executed this
Agreement as of the date set forth above.
ALZA CORPORATION
By: /s/Xxxxx X. Staple
Title: Senior Vice President and General Counsel
CRESCENDO PHARMACEUTICALS CORPORATION
By: /s/ Xx. Xxxxx X Xxxxx
Title: President and Chief Executive Officer
EXHIBIT A
DEVELOPMENT COSTS
Development Costs are equal to the sum of (i) Research
Expenses, (ii) General and Administrative Expenses and (iii)
Capital Asset Expenditures.
(i) Research Expenses include both Direct Expenses and
Indirect Expenses, with the cost elements outlined on
Exhibit A-1.
(a) Direct Expenses include Direct Research
Salaries, Clinical Expenses, Supplies and other expenses
incurred specifically in connection with the Program.
(b) Indirect Expenses include Research Management
and support costs of the research and product development
organization. (Indirect Expenses are allocated to all
projects and billed to clients at a fixed rate* of 160% of
Direct Research Salaries.)
(ii) General and Administrative Expenses include cost
elements outlined on Exhibit A-2. (General and
Administrative Expenses are allocated among the research and
product development, manufacturing and marketing
organizations. The portion allocated to the research and
product development organization is then allocated to all
projects and billed to clients at a fixed rate* of 80% of
Direct Research Salaries.)
(iii) Capital Asset Expenditures are the actual costs of
new capital assets acquired specifically for the project.
* This fixed billing rate will not be changed prior to
January 1, 1998 and, if changed on or after January 1, 1998,
such changes will be limited to not more than one change per
calendar year and shall be a maximum of 10% of the rate in
effect at the time of the increase.
EXHIBIT A-1
Research Expenses
Direct Expenses
_________________
Direct Research Salaries*
Project Clinical Expenses and Outside Services
Project Specific Supplies
Project Travel and Related Expenses
Miscellaneous Project Expenses
Regulatory and Filing Fees and Maintenance Payments
Indirect Expenses
_________________
Research Management and Indirect Salaries*
General Research Supplies and Materials
General Research Consulting and Outside Services
Facilities Expenses
Telephone and Communications
Equipment Depreciation, Rent, Maintenance and Services
Research Travel and Related Expenses
Patent and Trademark Expenses
Miscellaneous Indirect Research Expenses
*Salaries include Benefits
EXHIBIT A-2
General and Administrative Expense
Corporate Management, Administrative, and Indirect Salaries*
Telephone and Communications
Equipment Depreciation, Rent, Maintenance and Services
Board of Directors and Corporate Consulting
Annual Audit, Accounting and Legal Expenses Facilities Expenses
Information Services (Data Processing) Expenses Interest Expense
Miscellaneous General and Administrative Expenses
*Salaries include Benefits
