EXHIBIT 10.1
DEVELOPMENT AND LICENSE AGREEMENT
BY AND BETWEEN
CIMA LABS INC.
AND
AVENTIS PHARMACEUTICALS INC.
DATED AS OF AUGUST 1, 2001
August 1, 2001
DEVELOPMENT AND LICENSE AGREEMENT
This DEVELOPMENT AND LICENSE AGREEMENT ("this Agreement"), dated as of
August 1, 2001 is by and between CIMA LABS INC., a Delaware corporation
("CIMA"), and AVENTIS PHARMACEUTICALS Inc., a Delaware corporation ("AVENTIS").
WITNESSETH
WHEREAS, CIMA is engaged, among other things, in the business of
research, development, manufacturing and commercialization of pharmaceutical
products through its proprietary drug delivery technologies;
WHEREAS, AVENTIS is engaged, among other things, in the business of
researching, developing, manufacturing, marketing and commercializing of
pharmaceutical products;
WHEREAS, subject to the terms and conditions set forth in this
Agreement, CIMA and AVENTIS wish to collaborate in the development and
manufacture of a certain prescription product owned by AVENTIS; and
WHEREAS, subject to the terms and conditions set forth in this
Agreement, CIMA wishes to license to AVENTIS and AVENTIS wishes to license from
CIMA rights to CIMA's OraSolv(R) technology for use with such prescription
product.
NOW, THEREFORE, the parties hereto, intending to be legally bound,
hereby agree as follows:
SECTION 1
DEFINITIONS
For purposes of this Agreement, the following terms shall have the
meanings set forth below:
"Activities" shall mean the development of the Product in the Territory
as contemplated by this Agreement.
"Affiliates" shall mean, with respect to any Person, any Person
directly or indirectly controlling, controlled by, or under common control with,
such other Person. For purposes hereof, the term "controlled" (including the
terms "controlled by" and "under common control with"), as used with respect to
any Person, shall mean the direct or indirect ability or power to direct or
cause the direction of management policies of such Person or otherwise direct
the affairs of such Person, whether through ownership of voting securities or
otherwise.
"Annual Net Sales" shall mean, for any Year, the Net Sales for such
Year.
"Active Pharmaceutical Ingredient or API" shall mean the active
ingredient fexofenadine.
"AVENTIS" shall have the meaning given in the preamble and shall
include its Affiliates.
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"AVENTIS Trademarks" shall have the meaning given in Section 8.9(c).
"cGMP" shall mean current Good Manufacturing Practices, as determined
by the FDA from time to time.
"CIMA" shall have the meaning given in the preamble and shall include
its Affiliates.
"CIMA Intellectual Property" shall mean, collectively, 1) the CIMA
Patents, and 2) the CIMA Technology.
"CIMA Patents" shall mean U.S. Patents 5,178,878, 6,024,981, 6,155,423,
and 6,221,392 (entitled 'Effervescent Dosage Form with Microparticles', 'Rapidly
Dissolving Robust Dosage Form', 'Blister Package and Packaged Tablet' and
'Rapidly Dissolving Robust Dosage Form' respectively) and any patents and patent
applications resulting therefrom, including any foreign counterparts, extension,
reissue, renewal, reexamination or continuation-in-part of such patent or patent
application.
"CIMA Technology" shall mean all of CIMA's trade secrets, technology,
know-how and all other information necessary or desirable for the manufacture of
the Product including, without limitation, that related to CIMA's OraSolv(R) and
PakSolv(TM) technologies.
"CIMA Trademarks" shall mean the CIMA(R), the CIMA(TM), DuraSolv(TM),
OraSolv(R), and PakSolv(TM) trademarks.
"Damages" shall mean any and all actions, costs, losses, claims,
liabilities, fines, penalties, demands, damages and expenses, court costs, and
reasonable fees and disbursements of counsel, consultants and expert witnesses
incurred by a party hereto (including interest which may be imposed in
connection therewith) but shall not include incidental, consequential, special
or punitive damages.
"Defective" shall mean, as to the Product, the failure of such to
strictly conform to the Specifications and all applicable laws and regulations,
including, without limitation, FDA regulatory filings and cGMP.
"Development Schedule" shall mean the schedule of development
activities set forth on Schedule A hereto.
"Effective Date" shall mean the date of this Agreement.
"FDA" shall mean the United States Food and Drug Administration.
"Force Majeure" shall mean acts of God, explosion, fire, flood,
tornadoes, thunderstorms, earthquake or tremor, war whether declared or not,
civil strife, riots, embargo, losses or shortages of power, labor stoppage,
substance shortages, currency restrictions, or events caused by reason of laws,
regulations or orders by any government, governmental agency or instrumentality
or by any other supervening or unforeseeable circumstances reasonably beyond the
control of each party.
"Indemnified Party" shall have the meaning given in Section 9.2 hereof.
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"Indemnifying Party" shall have the meaning given in Section 9.2
hereof.
"Launch" shall mean the date when the Product is first made
commercially available by AVENTIS within the Territory.
"Licensed Assets" shall have the meaning set forth in Section 2.1
hereof.
"Net Sales" shall mean gross sales of Products sold by AVENTIS and its
respective Affiliates and licensees to third parties in the Territory, less the
total of (a) trade, cash, and/or quantity discounts; (b) excise, sales and other
consumption taxes and customs duties to the extent included in the invoice
price; (c) freight, insurance and other transportation charges to the extent
included in the invoice price; (d) amounts repaid or credited by reason of
rejections and defects; (e) returns and retroactive price reductions; and (f)
compulsory payments and rebates, accrued, paid or deducted pursuant to
agreements (including, but not limited to, managed care agreements).
"OraSolv(R)" shall mean CIMA's orally disintegrating tablet
formulations and related technology as described in the CIMA Patents.
"PDMA" shall mean the Prescription Drug Marketing Act of 1987, as
amended from time to time, together with any rules or regulations promulgated
thereunder.
"Person" shall mean a natural person, a corporation, a partnership, a
trust, a joint venture, a limited liability company, any governmental authority
or any other entity or organization.
"Product" shall mean pharmaceutical preparations containing the Active
Pharmaceutical Ingredient as the sole ingredient formulated with the OraSolv(R)
technology in final packaged form ready for sale to customers in the Territory.
"Quarter" shall mean, as the case may be, the three months ending on
March 31, June 30, September 30 or December 31 in any Year.
"Specifications" shall mean, at any time, the specifications for the
Product that are agreed to from time to time by AVENTIS and CIMA.
"Territory" shall mean the entire world.
"Valid Claim" shall mean a claim which, but for the license granted
hereunder, would be infringed by AVENTIS' use, manufacture or sale of a Product,
and which is covered by an issued unexpired patent included within the CIMA
Patents which has not been held invalid or unenforceable by a decision of a
court or governmental agency of competent jurisdiction, unappealable or
unappealed within the time allowed for appeal, and which has not been
disclaimed, denied or admitted to be invalid or unenforceable by the owner
through reissue , disclaimer or otherwise.
"Year" shall mean a calendar year during the term of this Agreement.
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SECTION 2
GRANT OF LICENSES; LICENSE OPTION
2.1 Grant of Licenses.
(a) CIMA hereby grants to AVENTIS an exclusive license, even as to CIMA
(except to the extent necessary for CIMA to fulfill its responsibilities under
this Agreement, including without limitation in connection with the Activities
and to make or have made Product for Aventis or its Affiliates or sublicensees),
to the following assets (such assets are referred to herein collectively as the
"Licensed Assets"):
(i) all current and future regulatory filings, approvals,
registrations and governmental authorizations obtained by
CIMA that relate to the Product in the Territory;
(ii) the CIMA Intellectual Property; and
(iii) the CIMA Trademarks,
for the term of this Agreement to make, have made, use, market, distribute,
import, sell, have sold or offer for sale the Product in the Territory .
(b) The license to AVENTIS will be exclusive in that (i) CIMA will not
grant to any Person in the Territory during the term of this Agreement any
licenses for the Licensed Assets with respect to products containing the Active
Pharmaceutical Ingredient, and (ii) CIMA will not itself use the Licensed Assets
in the Territory during the term of this Agreement to make, have made, use ,
import, sell, have sold or offer for sale any product containing the Active
Pharmaceutical Ingredient except as permitted in Section 2.1 above.
2.2 Sublicenses. AVENTIS shall have the right to extend the licenses
granted pursuant to this Section 2 in whole or in part to any Affiliate of
AVENTIS, provided that AVENTIS is not then in default with respect to any of its
obligations to CIMA under this Agreement. All the terms and provisions of this
Agreement shall apply to the Affiliate to which this license has been extended
to the same extent as they apply to AVENTIS, and the operations of the Affiliate
shall be deemed to be the operations of AVENTIS and AVENTIS shall account
therefore and be responsible for the performance by such Affiliate of all of its
obligations hereunder. In addition, AVENTIS shall have the right to extend the
licenses granted pursuant to this Section 2 in whole or in part to Persons who
are not Affiliates of AVENTIS with the prior written consent of CIMA, such
consent not to be unreasonably withheld or delayed, provided that AVENTIS is not
then in default with respect to any of its material obligations to CIMA under
this Agreement. All the terms and provisions of this Agreement shall apply to
such sublicensee to the same extent as they apply to AVENTIS and the operations
of any such authorized Person shall be deemed to be the operations of AVENTIS
and AVENTIS shall account therefore and be responsible for the performance of
such Person of all of its obligations hereunder.
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2.3 Development, Marketing, Distribution and Sale. Prior to and after
the Launch, AVENTIS shall use its commercially reasonable efforts to market,
distribute and sell the Product in the Territory. Such efforts shall be
consistent with industry norms, given the product profile, product potential and
the state of the market at Launch and as it develops after Launch.
SECTION 3
PRODUCT DEVELOPMENT
3.1 Obligations of CIMA. CIMA shall use commercially reasonable efforts
to satisfactorily perform each of the development activities set forth on
Schedule A and shall complete such activities within the timeframes set forth on
Schedule A.
3.2 Obligations of AVENTIS. AVENTIS shall, in a timely fashion, pay
CIMA the development fees noted in Schedule A.
3.3 Regulatory Matters. All Product supplied to AVENTIS shall be
produced under cGMP and in accordance with the Specifications. CIMA shall
furnish AVENTIS with a Certificate of Analysis with a cGMP statement to
demonstrate that each shipment of Product has been manufactured under cGMP and
in accordance with the Specifications. In addition, AVENTIS reserves the right,
at its own expense, to audit the facility of CIMA, including its processes,
records and other facets of the operation as may be necessary to assure that all
applicable regulations have been complied with and the Specifications have been
met. CIMA shall permit duly authorized representatives of AVENTIS to audit all
manufacturing and processing operations related to this Agreement at reasonable
times with a prior appointment. The right to audit shall commence with the
Effective Date. These audits will be conducted to assure compliance with all
pertinent acts, regulations, and guidelines promulgated by the FDA and other
regulatory authorities, as well as standards then in effect in the regulatory
environment. Such audits will be permitted during normal business hours and will
be performed with a minimum of disruption.
SECTION 4
ROYALTY, TECHNOLOGY DEVELOPMENT AND MILESTONE PAYMENTS
4.1 Royalty, Technology Development and Milestone Payments.
(a) In partial consideration of the licenses granted in Section
2.1, AVENTIS shall make royalty payments to CIMA in the amounts set forth on
Schedule B.
(b) In partial consideration of the licenses granted in Section
2.1 and the Activities performed by CIMA, AVENTIS shall make the technology
development and milestone payments to CIMA as set forth on Schedule C.
(c) In the event that sales of Product in the United States are
to be made through [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***], rather than
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***] as currently contemplated by the Parties,
AVENTIS and CIMA agree to re-negotiate in good faith the [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION***] this Agreement.
4.2 Records and Audit. AVENTIS and its Affiliates shall keep true and
accurate books of account containing all particulars that may be necessary for
the purpose of showing the amounts payable to CIMA hereunder. Such books and the
supporting data shall be open, at all reasonable times and upon reasonable
notice during the term of this Agreement and for two (2) Years after its
termination, to the inspection by a firm of certified public accountants
selected by CIMA and reasonably acceptable to AVENTIS, for the limited purpose
of verifying AVENTIS' royalty statements; provided, however, that such
examination shall not take place more often than once each Year and shall not
cover more than the preceding two (2) Years, with no right to audit any period
previously audited. Except as otherwise provided in this Section, the cost of
any such examination shall be paid by CIMA. In the event that any such
inspection reveals a deficiency in excess of [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***] of the reported royalty for the period covered by the inspection,
AVENTIS shall promptly pay CIMA the deficiency, plus interest at the rate of
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***] per annum (which interest shall accrue
from the date any such payment was originally due) and shall reimburse CIMA for
the reasonable fees and expenses paid to such accountants in connection with
their inspection. In the event that any such inspection reveals a deficiency of
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***] of the reported royalty for the period
covered by the inspection, AVENTIS shall promptly pay CIMA the deficiency, plus
interest at the rate of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] per annum
(which interest shall accrue from the date any such payment was originally due)
and shall reimburse CIMA for [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] the
reasonable fees and expenses paid to such accountants in connection with their
inspection. In the event that any such inspection reveals a deficiency that is
less than [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION***] of the reported royalty for the
period covered by the inspection, AVENTIS shall promptly pay CIMA the
deficiency, plus interest at the rate of [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]
per annum (which interest shall accrue from the date any such payment was
originally due). In the event that any such inspection reveals any overpayment
by AVENTIS to CIMA, CIMA shall promptly pay AVENTIS the difference between what
was due and the overpayment, plus interest at the rate of [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION***] per annum (which interest shall accrue from the date any
such payment was
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originally due). The parties agree that neither party shall be
required to retain books and records with respect to the above other than books
and records relating to the current Year and the immediately preceding two (2)
Years.
4.3 Quarterly Reports and Payment of Royalties. AVENTIS shall, within
forty-five (45) days after the end of each Quarter, deliver to CIMA a written
report (the "Royalty Statement") describing: (i) the Net Sales during the
Quarter; and 2) the calculation used to determine the total royalties due for
the Quarter pursuant to Section 4.1 (a). AVENTIS shall pay such royalties in
United States dollars within sixty (60) days after the end of each Quarter by
wire transfer or such other method as CIMA may designate. If no royalties are
due, AVENTIS shall so report. In those cases where the amount due is calculated
based on one or more currencies other than the US dollar, the amount due in US
dollars shall be calculated using the average rate of exchange for such
currencies, as quoted in the Financial Times, for the last business day of each
of the three months in the calendar quarter to which such payment pertains.
4.4 Term of Royalty. AVENTIS' royalty obligations to CIMA hereunder
shall terminate upon the later of (i) ten (10) years from the Effective Date of
this Agreement or (ii) on a country-by-country basis, on the expiration date in
such country of the last to expire of issued CIMA Patents which include at least
one Valid Claim covering the manufacture, sale or use of the Product in such
country. Notwithstanding anything to the contrary contained in the previous
sentence, the Parties agree that in the event that (a) the ten (10) year period
referred to in (i) above has not expired and a Valid Claim does not exist
covering the manufacture, sale or use of the Product and (b) a third party
commences the sale of a product containing the API and CIMA Technology in a
country where a Valid Claim does not exist, then AVENTIS shall not owe CIMA any
royalties for its sale of Products in such country until the third party sale
ceases. Upon expiration or termination of AVENTIS' royalty obligation in any
country, AVENTIS shall have the royalty-free right in that country to continue
using the CIMA Technology furnished hereunder in that country.
SECTION 5
SUPPLY OF PRODUCT
5.1 Supply Agreement. After the Effective Date hereof, the parties
shall enter into good faith negotiations for commercial supply of Product by
CIMA to AVENTIS. The supply agreement shall have an initial term of
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***], which term shall commence from the first
shipment of commercial Product (the "Initial Term"). On the [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION***] anniversary of the Initial Term, AVENTIS shall notify
CIMA whether it (i) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] of the Product, (ii)
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***]
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after the expiration of the Initial Term or (iii) [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***], or other period of time as the parties shall mutually agree,
after the expiration of the Initial Term. When AVENTIS notifies CIMA that it
desires to proceed with either (i), (ii) or (iii), then AVENTIS shall pay CIMA
the technology transfer fee(s) set forth in Section 5.2 below. During the term
of the supply agreement, AVENTIS shall provide the [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***] for the manufacturing of tablets of Product. The supply agreement
will contain provisions consistent with CIMA's supply agreements between CIMA
and its other major pharmaceutical partners and otherwise acceptable to the
parties. CIMA's prices for supplying Product to Aventis shall not exceed the
prices in Schedule D; provided however such prices may be increased annually
based upon increases in a Producer Price Index (details to be included in the
Supply Agreement) not to exceed [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] per
year.
5.2 [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] AVENTIS. When AVENTIS
notifies CIMA that it intends to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] of the
Product pursuant to Section 5.1 (i) or (ii) above, AVENTIS shall pay CIMA the
following: (i) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] at the time AVENTIS
notifies CIMA of its [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] of the Product (which
payment shall be refundable to AVENTIS if CIMA does not adhere to the below
mentioned schedule other than by reason of a Force Majeure event or the actions
or inactions of AVENTIS) and (ii) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] upon
the successful completion of the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] of
Product and [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] upon the successful
completion of the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] of Product pursuant
to the schedule agreed to between the parties, which, in any event, shall not
exceed [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION***] from the date AVENTIS first
notifies CIMA of its [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] of the Product. In
the event that AVENTIS notifies CIMA that it [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***] of the Product pursuant to Section 5.1 (iii) above, AVENTIS shall
pay CIMA the following: (i) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] at the
time
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AVENTIS notifies CIMA of its [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] of the
Product and (ii) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] upon the successful
completion of the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] of Product and
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***] upon the successful completion of the
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***] of Product, pursuant to the schedule
agreed between the parties, which, in any event, shall not exceed
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***] from the date AVENTIS first notifies CIMA
of it's [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION***] of the Product. . The parties
agree that successful completion of the [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]
of Product shall include, inter alia, at least [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***] batches, manufactured according to the manufacturing batch record
and meeting the requirement of the validation protocol for certain critical
parameters that may affect Product safety, quality or efficacy. In addition,
AVENTIS shall pay to CIMA 100% of CIMA's reasonable expenses for activities
requested by AVENTIS related to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]
including CIMA's personnel time for [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***]. CIMA's personnel will be charged out at a daily full time
equivalent rate of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***], which shall include
at least an [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***].
SECTION 6
REPRESENTATIONS AND WARRANTIES OF CIMA
CIMA hereby represents and warrants to AVENTIS that:
6.1 Organization, Power and Authority. CIMA is a corporation duly
organized and validly existing under the laws of the State of Delaware. CIMA has
all necessary corporate power and authority to enter into, and be bound by the
terms and conditions of, this Agreement, and to license the Licensed Assets to
AVENTIS pursuant hereto.
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6.2 Due Authority; No Breach. The execution, delivery and performance
by CIMA of this Agreement and the performance of the transactions contemplated
hereby, have been duly authorized by all necessary corporate action by CIMA.
Neither the execution and delivery of this Agreement, nor the performance of the
obligations contemplated hereby, will (i) conflict with or result in any
violation of or constitute a breach of any of the terms or provisions of, or
result in the acceleration of any obligation under, or constitute a default
under any provision of the articles of incorporation or by-laws of CIMA or any
material contract or any other material obligation to which CIMA is a party or
to which it is subject or bound, or (ii) violate any judgment, order,
injunction, decree or award of any court, administrative agency, arbitrator or
governmental body against, or affecting or binding upon, CIMA or upon the
securities, property or business of CIMA, or (iii) constitute a violation by
CIMA of any applicable law or regulation of any jurisdiction as such law or
regulation relates to CIMA, or to the property or business of CIMA except for
such conflict, acceleration, default, breach or violation that is not reasonably
likely to have a material adverse effect on CIMA's ability to perform its
obligations under this Agreement.
6.3 Intellectual Property. CIMA is the lawful owner of the Licensed
Assets and CIMA can license the Licensed Assets without the consent of any third
party. There is no pending or, to its knowledge, overtly threatened claim
against CIMA asserting that any of the Licensed Assets infringes or violates the
rights of third parties or that AVENTIS, by practicing under the Licensed Assets
in performing the Activities, would violate any of the intellectual property
rights of any third party, and nothing has come to the attention of CIMA which
has, or reasonably should have, led CIMA to believe that any of the Licensed
Assets infringes or violates the right of third parties. CIMA is not aware of
and has not received any communications challenging the ownership, validity or
effectiveness of any of the Licensed Assets. CIMA has not granted any right to
any third party relating to the Activities which would violate the terms of or
conflict with the rights granted to AVENTIS pursuant to this Agreement.
6.4 Technology Rights. The CIMA Intellectual Property, when combined
with the Active Pharmaceutical Ingredient, to the best of CIMA's knowledge,
includes all the technology, patents, know-how, trade secrets and other
intellectual property necessary or desirable to manufacture the Product.
6.5 Litigation. As of the Effective Date of this Agreement, CIMA is not
aware of any pending or threatened judicial, administrative or arbitral actions,
claims, suits or proceedings against CIMA relating to the Activities or the
Licensed Assets which, either individually or together with any other, would
have a material adverse effect on the Activities or the Licensed Assets or the
ability of CIMA to perform its obligations under this Agreement.
6.6 Governmental Approval. No consent, approval, waiver, order or
authorization of, or registration, declaration or filing with, any governmental
authority is required in connection with the execution and delivery of this
Agreement by CIMA.
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SECTION 7
REPRESENTATIONS AND WARRANTIES OF AVENTIS
AVENTIS represents and warrants to CIMA that:
7.1 Organization, Power and Authority. AVENTIS is a corporation duly
organized, validly existing and in good standing under the laws of the State of
Delaware. AVENTIS has all necessary corporate power and authority to enter into,
and be bound by the terms and conditions of, this Agreement and to license the
Licensed Assets from CIMA.
7.2 Due Authority; No Breach. The execution, delivery and performance
by AVENTIS of this Agreement and the performance of the transactions
contemplated hereby have been duly authorized by all necessary corporate action
by AVENTIS. Neither the execution and delivery of this Agreement by AVENTIS, nor
the performance of the obligations contemplated hereby, will (i) conflict with
or result in any violation of or constitute a breach of any of the terms or
provisions of, or result in the acceleration of any obligation under, or
constitute a default under any provision of its articles of incorporation or
by-laws or any material contract or any other material obligation to which
AVENTIS is a party or to which it is subject or bound, or (ii) violate any
judgment, order, injunction, decree or award of any court, administrative
agency, arbitrator or government body against, or affecting or binding upon,
AVENTIS or upon the securities, property or business of AVENTIS, or (iii)
constitute a violation by AVENTIS of any applicable law or regulation of any
jurisdiction as such law or regulation relates to AVENTIS or to the property or
business of AVENTIS, except for such conflict, acceleration, default, breach or
violation that is not reasonably likely to have a material adverse effect on
AVENTIS' ability to perform its obligations under this Agreement.
7.3 Litigation. As of the Effective Date of this Agreement, AVENTIS is
not aware of any pending or threatened judicial, administrative or arbitral
actions, claims, suits or proceedings against AVENTIS which, either individually
or together with any other, will have a material adverse effect on the ability
of AVENTIS to perform its obligations under this Agreement or any agreement or
instrument contemplated hereby.
7.4 Governmental Approval. No consent, approval, waiver, order or
authorization of, or registration, declaration or filing with, any governmental
authority is required in connection with the execution and delivery of this
Agreement by AVENTIS.
SECTION 8
ADDITIONAL COVENANTS AND AGREEMENTS OF THE PARTIES
8.1 Governmental Filings. CIMA and AVENTIS each agree to prepare and
file whatever filings, listings, requests or applications are required to be
filed with any governmental authority in connection with this Agreement or the
Product and to cooperate with one another as reasonably necessary to accomplish
the foregoing.
8.2 Compliance with Law. AVENTIS and CIMA shall each comply with all
federal, state and local laws and regulations applicable to developing,
approving, manufacturing,
12
marketing and selling the Product in the Territory and the Licensed Assets or
the performance of their respective obligations hereunder. CIMA and AVENTIS each
shall keep all records and reports required to be kept by applicable laws and
regulations, and each shall make its facilities available at reasonable times
during business hours for inspection by representatives of governmental
agencies. CIMA and AVENTIS each shall notify the other within forty-eight (48)
hours of receipt of any notice or any other indication whatsoever of any FDA or
other governmental agency inspection, investigation or other inquiry, or other
material notice or communication of any type, involving the Product. AVENTIS and
CIMA shall cooperate with each other during any such inspection, investigation
or other inquiry including, but not limited to, allowing upon request a
representative of the other to be present during the applicable portions of any
such inspection, investigation or other inquiry and providing copies of all
relevant documents. AVENTIS and CIMA shall discuss any written response to
observations or notifications received in connection with any such inspection,
investigation or other inquiry and each shall give the other an opportunity to
comment upon any proposed response before it is made. In the event of
disagreement concerning the form or content of such response, however, CIMA
shall be responsible for deciding the appropriate form and content of any
response with respect to any of its cited activities and AVENTIS shall be
responsible for deciding the appropriate form and content of any response with
respect to any of its cited activities.
8.3 Recall. AVENTIS shall advise CIMA of its decision concerning any
recall or withdrawal of the Product from the market. CIMA shall bear the costs
(including but not limited to, shipping and product replacement) for any recall
or withdrawal due to CIMA's failure to comply with this Agreement. The costs for
any other recall or withdrawal shall be the responsibility of AVENTIS.
8.4 Confidentiality. AVENTIS shall treat as confidential the Licensed
Assets and all other confidential or proprietary information of CIMA of which
AVENTIS becomes aware in connection with this Agreement (collectively, "CIMA
Proprietary Information"). AVENTIS shall neither disclose CIMA Proprietary
Information to any third party nor use CIMA Proprietary Information for any
purpose other than as set forth in this Agreement. CIMA shall treat as
confidential all confidential or proprietary information of AVENTIS of which
CIMA becomes aware in connection with this Agreement (collectively, "AVENTIS
Proprietary Information"). CIMA shall neither disclose AVENTIS Proprietary
Information to any third party nor use AVENTIS Proprietary Information for any
purpose other than as set forth in this Agreement. Nothing contained herein will
in any way restrict or impair either party's (the "Using Party's") right to use,
disclose or otherwise deal with any Proprietary Information of the other party
which:
(a) at the time of disclosure is known to the public or
thereafter becomes known to the public by publication or otherwise
through no fault of the Using Party;
(b) the Using Party can establish was in its possession prior
to the time of the disclosure and was not obtained directly or
indirectly from the other party;
(c) is independently made available as a matter of right to
the Using Party by a third party who is not thereby in violation of a
confidential relationship with the other party;
13
(d) is developed by the Using Party independently of the
Proprietary Information received from the other party and the Using
Party can establish such development; or
(e) is information required to be disclosed by legal or
regulatory process; provided, in each case the Using Party timely
informs the other party and uses reasonable efforts to limit the
disclosure and maintain confidentiality to the extent possible and
permits the other party to intervene and contest or attempt to limit
the disclosure.
AVENTIS shall obtain no right or license of any kind under the CIMA Proprietary
Information except as set forth in this Agreement. CIMA shall obtain no right or
license of any kind under the AVENTIS Proprietary Information except as set
forth in this Agreement.
8.5 Expenses. CIMA and AVENTIS shall each bear their own direct and
indirect expenses incurred in connection with the negotiation and preparation of
this Agreement and, except as set forth in this Agreement, the performance of
the obligations contemplated hereby.
8.6 Publicity. The parties agree that no publicity release or
announcement concerning the transactions contemplated hereby shall be issued
without the advance written consent of the other, except as such release or
announcement may be required by law, including but not limited to the Securities
Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, in
which case the party making the release or announcement shall, before making any
such release or announcement, afford the other party a reasonable opportunity to
review and comment upon such release or announcement.
14
8.7 Cooperation. If either party shall become engaged in or participate
in any investigation, claim, litigation or other proceeding with any third
party, including the FDA, relating in any way to the Product or any of the
Licensed Assets, the other party shall cooperate in all reasonable respects with
such party in connection therewith, including, without limitation, using its
reasonable efforts to make available to the other such employees who may be
helpful with respect to such investigation, claim, litigation or other
proceeding.
8.8 Conflicting Rights. CIMA shall not grant any right to any third
party relating to the Activities which would violate the terms of or conflict
with the rights granted to AVENTIS pursuant to this Agreement.
8.9 Patent and Trademark Maintenance.
(a) CIMA shall be solely responsible for filing, prosecuting,
and maintaining all of the CIMA Patents, and CIMA shall pay the costs
associated therewith. CIMA shall file, prosecute, and maintain all CIMA
Patents so as to fully continue the benefits under the licenses granted
to AVENTIS hereunder. CIMA may, however, discontinue prosecuting and
maintaining any CIMA Patent if (i) CIMA has a valid business reason to
do so, and (ii) obtains the prior written approval of AVENTIS, such
approval not to be unreasonably withheld or delayed.
(b) CIMA shall be solely responsible for filing, prosecuting,
and maintaining all CIMA Trademarks, and CIMA shall pay the costs
associated therewith. All registrations, variations, logos, goodwill
and other rights under or acquired through use of the CIMA Trademarks
shall accrue and belong to CIMA. Except as provided herein, AVENTIS
shall have no rights to use the CIMA Trademarks. AVENTIS will not use
in its business, in or outside of the Territory, any other ▇▇▇▇ or name
which is similar to or nearly resembles any of the CIMA Trademarks as
to be likely to cause deception or confusion. AVENTIS recognizes that
CIMA is the owner of all CIMA Trademarks used in commerce to indicate
the source of the CIMA Intellectual Property and agrees that the CIMA
Trademarks shall remain vested in CIMA both during the term of this
Agreement and thereafter. AVENTIS shall not contest the validity of the
CIMA Trademarks or CIMA's ownership of the CIMA Trademarks. Use of the
CIMA Trademarks by AVENTIS in conjunction with the development,
marketing, selling and distribution of the Product and all goodwill
related thereto shall inure to the benefit of CIMA for purposes of
building the longevity and extent of use of the CIMA Trademarks.
(c) AVENTIS shall be solely responsible for filing,
prosecuting, and maintaining all trademarks it develops or owns for the
Product (the "AVENTIS Trademarks"), and AVENTIS shall pay the costs
associated therewith. All registrations, variations, logos, goodwill
and other rights under or acquired through use of the AVENTIS
Trademarks shall accrue and belong to AVENTIS. CIMA shall have no
rights to use the AVENTIS Trademarks. CIMA will not use in its
business, in or outside of the Territory, any other ▇▇▇▇ or name which
is similar to or nearly resembles the AVENTIS Trademarks in use by
AVENTIS in a manner that is likely to cause deception or confusion.
CIMA recognizes that AVENTIS is the owner of all of the AVENTIS
Trademarks used in commerce to indicate the source of the Product and
agrees that the AVENTIS Trademarks shall remain vested in AVENTIS both
during the term of this
15
Agreement and thereafter. CIMA shall not contest the validity of the
AVENTIS Trademarks or AVENTIS' ownership of the AVENTIS Trademarks. Use
of the AVENTIS Trademarks by AVENTIS in conjunction with the
manufacture, use, and sale of the Product and all goodwill related
thereto shall inure to the benefit of AVENTIS for purposes of building
the longevity and extent of use of the AVENTIS Trademarks.
(d) AVENTIS and CIMA agree that, where applicable, all
packaging of the Product shall: (i) identify the number of the CIMA
Patents and CIMA as the owner thereof; and (ii) include CIMA's logo on
the front, back or either side of the carton for Product for sale in
the United States.
8.10 Infringement; Enforcement of Proprietary Rights.
(a) Infringement of Patent Rights. Each party shall promptly
notify the other of any alleged infringement by third parties of any
CIMA Patent and provide any information available to that party
relating to such alleged infringement. CIMA shall investigate such
alleged infringement and shall have the first right, but not the
obligation, to end any infringement of such rights that materially
affect AVENTIS' rights pursuant to this Agreement, including, but not
limited to, bringing suit against such third party infringer at its own
expense. In the event that CIMA does not bring suit against such third
party infringer, AVENTIS may, at its own expense, bring suit against
such third party infringer on CIMA's behalf.
(b) Procedures. No settlement, consent judgment or other
voluntary final disposition of any suit contemplated by Section 8.10(a)
may be entered into without the consent of each party, which consent
shall not be unreasonably withheld or delayed. Any recovery of damages
in any such suit shall be retained by the party bearing the costs of
such suit. In the event of any infringement suit against a third party
brought by either party pursuant to this Section 8.10, the party not
bringing such suit shall cooperate in all respects, execute any
documents reasonably necessary to permit the other party to prosecute
such suit, and to the extent reasonable shall make available its
employees and relevant records to provide evidence for such suit.
8.11 Referral of Orders and Inquiries. CIMA shall refer all
Persons sending orders or making inquiries regarding the Product within
the Territory to AVENTIS and shall promptly notify AVENTIS of the name
of each such Person and the nature of the inquiry of such Person.
8.12 Ownership.
(a) Subject to the license rights granted hereunder, ownership
of CIMA Proprietary Information, CIMA Intellectual Property
and CIMA Trademarks shall remain with CIMA and ownership of
AVENTIS Proprietary Information, AVENTIS Intellectual Property
and AVENTIS Trademarks shall remain with AVENTIS. Nothing
herein is intended to transfer the ownership of any party's
confidential information, know-how, or patent rights to the
other party. In addition, each party to this Agreement
maintains the right to use its own confidential information,
know-how, or patent rights, for any purpose, except as
16
specifically restricted herein.
(b) Inventorship of inventions arising from the Activities in
the development process contemplated by this Agreement shall
be determined in accordance with the patent laws of the United
States. All employees of either Party who shall be deemed
inventors under such law shall be named as inventors on the
relevant patent applications. Each Party shall ensure that its
employees are under an obligation to properly assign any such
invention to the respective Party.
(c) AVENTIS and CIMA agree that all right, title and interest
to any improvements made to a respective originating party's
know-how and/or patent rights by either party under this
Agreement shall reside with the originating party of such
know-how and/or patent rights. As such, if such improvements
are made, conceived, or reduced to practice by such
non-originating party, such non-originating party shall assist
the originating party in perfecting, where applicable, all
right, title and interest, including, but not limited to the
prosecution and assignment of any patentable intellectual
property rights thereto to such improvements, at the
originating party's expense.
(d) The parties further agree and acknowledge that any and all
data and information generated under the Activities set forth
in Schedule A or under the Formulation Agreement shall belong
to AVENTIS.
SECTION 9
INDEMNIFICATION
9.1 Indemnification.
(a) CIMA shall indemnify, defend and hold AVENTIS (and its
directors, officers, employees, and Affiliates) harmless from and
against any and all Damages incurred or suffered by AVENTIS (and its
directors, officers, employees, and Affiliates) as a consequence of:
(i) any breach of any representation or warranty made
by CIMA in this Agreement;
(ii) any failure to perform duly and punctually any
covenant, agreement or undertaking on the part of CIMA
contained in this Agreement; or
(iii) any act or omission of CIMA with respect to the
operation of CIMA's business or the handling, manufacturing,
or use of the Product by CIMA.
(b) AVENTIS shall indemnify, defend and hold CIMA (and its
directors, officers, employees, and Affiliates) harmless from and
against any and all Damages incurred or suffered by CIMA (and its
directors, officers, employees, and Affiliates) as a consequence of:
17
(i) any breach of any representation or warranty made
by AVENTIS in this Agreement;
(ii) any failure to perform duly and punctually any
covenant, agreement or undertaking on the part of AVENTIS
contained in this Agreement; or
(iii) any act or omission of AVENTIS with respect to
the operation of AVENTIS' business or the handling,
manufacturing, sale, consumption or use of the Product by
AVENTIS.
9.2 Notice and Opportunity To Defend. Promptly after receipt by a party
hereto of notice of any claim which could give rise to a right to
indemnification pursuant to Section 9.1, such party (the "Indemnified Party")
shall give the other party (the "Indemnifying Party") written notice describing
the claim in reasonable detail. The failure of an Indemnified Party to give
notice in the manner provided herein shall not relieve the Indemnifying Party of
its obligations under this Section, except to the extent that such failure to
give notice materially prejudices the Indemnifying Party's ability to defend
such claim. The Indemnifying Party shall have the right, at its option, to
compromise or defend, at its own expense and by its own counsel, any such matter
involving the asserted liability of the party seeking such indemnification. If
the Indemnifying Party shall undertake to compromise or defend any such asserted
liability, it shall promptly (and in any event not less than 10 days after
receipt of the Indemnified Party's original notice) notify the Indemnified Party
in writing of its intention to do so, and the Indemnified Party agrees to
cooperate fully with the Indemnifying Party and its counsel in the compromise or
defense against any such asserted liability. All reasonable costs and expenses
incurred in connection with such cooperation shall be borne by the Indemnifying
Party. If the Indemnifying Party elects not to compromise or defend the asserted
liability, fails to notify the Indemnified Party of its election to compromise
or defend as herein provided, fails to admit its obligation to indemnify under
this Agreement with respect to the claim, or, if in the reasonable opinion of
the Indemnified Party, the claim could result in the Indemnified Party becoming
subject to injunctive relief or relief other than the payment of money damages
that could materially adversely affect the ongoing business of the Indemnified
Party in any manner, the Indemnified Party shall have the right, at its option,
to pay, compromise or defend such asserted liability by its own counsel and its
reasonable costs and expenses shall be included as part of the indemnification
obligation of the Indemnifying Party hereunder. Notwithstanding the foregoing,
neither the Indemnifying Party nor the Indemnified Party may settle or
compromise any claim over the objection of the other; provided, however, that
consent to settlement or compromise shall not be unreasonably withheld. In any
event, the Indemnified Party and the Indemnifying Party may participate, at
their own expense, in the defense of such asserted liability. If the
Indemnifying Party chooses to defend any claim, the Indemnified Party shall make
available to the Indemnifying Party any books, records or other documents within
its control that are necessary or appropriate for such defense. Notwithstanding
anything to the contrary in this Section 9.2, (i) the party conducting the
defense of a claim shall (A) keep the other party informed on a reasonable and
timely basis as to the status of the defense of such claim (but only to the
extent such other party is not participating jointly in the defense of such
claim), and (B) conduct the defense of such claim in a prudent manner, and (ii)
the Indemnifying Party shall not cease to defend, settle or otherwise dispose of
any claim without the prior written consent of the Indemnified Party (which
consent shall not be unreasonably withheld).
18
9.3 Indemnification Payment. Upon the final determination of liability
and the amount of the indemnification payment under this Section 9, the
appropriate party shall pay to the other, as the case may be, within twenty (20)
business days after such determination, the amount of any claim for
indemnification made hereunder.
9.4 Survival. The provisions of Section 9 shall survive any termination
of this Agreement. Each Indemnified Party's rights under Section 9 shall not be
deemed to have been waived or otherwise affected by such Indemnified Party's
waiver of the breach of any representation, warranty, agreement or covenant
contained in or made pursuant to this Agreement, unless such waiver expressly
and in writing also waives any or all of the Indemnified Party's rights under
Section 9.
SECTION 10
TERMINATION
10.1 Term; Termination. The term of this Agreement shall begin on the
Effective Date and, unless sooner terminated as hereinafter provided, shall
continue until the later of (i) the expiration date of the last to expire CIMA
Patent containing a Valid Claim or (ii) for a period of ten (10) years from the
first commercial sale by Aventis of a Product to an independent third party.
Upon expiration of this Agreement in accordance with the preceding sentence, or
pursuant to Section 4.4. AVENTIS shall have the royalty-free right to continue
using the CIMA Technology furnished hereunder. Notwithstanding the foregoing,
this Agreement may be terminated as follows:
(a) Termination for Insolvency. If either AVENTIS or CIMA (i)
makes a general assignment for the benefit of creditors or becomes
insolvent; (ii) files an insolvency petition in bankruptcy; (iii)
petitions for or acquiesces in the appointment of any receiver, trustee
or similar officer to liquidate or conserve its business or any
substantial part of its assets; (iv) commences under the laws of any
jurisdiction any proceeding involving its insolvency, bankruptcy,
reorganization, adjustment of debt, dissolution, liquidation or any
other similar proceeding for the release of financially distressed
debtors; or (v) becomes a party to any proceeding or action of the type
described above in (iii) or (iv) and such proceeding or action remains
undismissed or unstayed for a period of more than 60 days, then the
other party may by written notice terminate this Agreement in its
entirety with immediate effect.
(b) Termination for Default. AVENTIS and CIMA each shall have
the right to terminate this Agreement for default upon the other's
failure to comply in any material respect with the terms and conditions
of this Agreement. At least 60 days prior to any such termination for
default, the party seeking to so terminate shall give the other written
notice of its intention to terminate this Agreement in accordance with
the provisions of this Section 10.1(b), which notice shall set forth
the default(s) which form the basis for such termination. If the
defaulting party fails to correct such default(s) within 60 days after
receipt of notification, then such party immediately may terminate this
Agreement. This Section 10.1(b) shall not be exclusive and shall not be
in lieu of any other remedies available to a party hereto for any
default hereunder on the part of the other party.
19
(c) Termination by AVENTIS. AVENTIS shall have the right to
terminate this Agreement for any reason, upon sixty (60) days written
notice to CIMA, provided, however that in the event that CIMA is
manufacturing the Product, AVENTIS shall have the right to terminate
this Agreement for any reason upon six (6) months written notice to
CIMA. In the event that AVENTIS terminates this Agreement under this
Section 10.1 (c) after the payment of the entire Technology Development
Fee contemplated by Schedule C but prior to Launch of the Product,
AVENTIS shall pay CIMA [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***], provided that CIMA is in compliance with of its
obligations under this Agreement at the time of termination. In the
event that AVENTIS terminates this Agreement under this Section 10.1
(c), then on the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] of the
Effective Date or upon termination if such termination takes place
after the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] of the
Effective Date, AVENTIS shall ▇▇▇▇▇ ▇▇▇▇ [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION***] related to the [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION***] of the Product [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION***] by CIMA under this Agreement to CIMA. AVENTIS
shall assist CIMA, at CIMA's expense and on CIMA's behalf, in the
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION***], including but not
limited to the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] of any
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION***] relating thereto. For
greater certainty, AVENTIS shall [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***] by CIMA or AVENTIS related to the Product and shall be a
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION***] with CIMA
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION***].
10.2 Continuing Obligations. Termination of this Agreement for any
reason shall not relieve the parties of any obligation accruing prior thereto
with respect to the Product and shall be without prejudice to the rights and
remedies of either party with respect to any antecedent breach of the provisions
of this Agreement. Without limiting the generality of the foregoing, no
termination of this Agreement, whether by lapse of time or otherwise, shall
serve to terminate the obligations of the parties hereto under Sections 8.3,
8.4, 8.5, 8.6, 8.12, 9, 10.2 and 11 hereof, and such obligations shall survive
any such termination.
20
SECTION 11
MISCELLANEOUS
11.1 Successors and Assigns. This Agreement shall be binding upon and
shall inure to the benefit of the parties hereto and their respective successors
and permitted assigns; provided, however, that neither CIMA nor AVENTIS may
assign any of its rights, duties or obligations hereunder without the prior
written consent of the other, which consent shall not be unreasonably withheld,
except that no prior written consent shall be required for (i) assignment to any
Affiliate who shall be substituted directly in whole or in part for it
hereunder; provided, however, that the assignor shall guarantee the performance
of its Affiliate assignee hereunder, or (ii) the successor or assignee of all or
substantially all of the Party's business or assets related to the subject
matter of this Agreement.
11.2 Notices. All notices or other communications required or permitted
to be given hereunder shall be in writing and shall be deemed to have been duly
given if delivered by hand or facsimile and confirmed in writing, or mailed
first class, postage prepaid, by registered or certified mail, return receipt
requested (mailed notices and notices sent by facsimile shall be deemed to have
been given on the date received) as follows:
If to CIMA, as follows:
CIMA LABS INC.
▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇
▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Facsimile: ▇▇▇-▇▇▇-▇▇▇▇
Attention: President and CEO
If to AVENTIS, as follows:
Aventis Pharmaceuticals Inc.
▇▇▇▇▇ ▇▇▇-▇▇▇
▇▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Facsimile: ▇▇▇-▇▇▇-▇▇▇▇
Attention: Senior Vice President Corporate Development
With a copy to Vice President, Legal Corporate Development
or in any case to such other address or addresses as hereafter shall be
furnished as provided in this Section 11.2 by any party hereto to the other
party.
11.3 Waiver; Remedies. Any term or provision of this Agreement may be
waived at any time by the party entitled to the benefit thereof by a written
instrument executed by such party. No delay on the part of CIMA or AVENTIS in
exercising any right, power or privilege hereunder shall operate as a waiver
thereof, nor shall any waiver on the part of either CIMA or AVENTIS of any
right, power or privilege hereunder operate as a waiver of any other right,
power or privilege hereunder nor shall any single or partial exercise of any
right, power or
21
privilege hereunder preclude any other or further exercise thereof or the
exercise of any other right, power or privilege hereunder.
11.4 Independent Contractors. The parties hereto are independent
contractors and nothing contained in this Agreement shall be deemed to create
the relationship of partners, joint venturers, or of principal and agent,
franchisor and franchisee, or of any association or relationship between the
parties other than as expressly provided in this Agreement. AVENTIS acknowledges
that it does not have, and AVENTIS shall not make representations to any third
party, either directly or indirectly, indicating that AVENTIS has any authority
to act for or on behalf of CIMA or to obligate CIMA in any way whatsoever. CIMA
acknowledges that it does not have, and it shall not make any representations to
any third party, either directly or indirectly, indicating that it has any
authority to act for or on behalf of AVENTIS or to obligate AVENTIS in any way
whatsoever.
11.5 Entire Agreement. This Agreement constitutes the entire agreement
between the parties with respect to the subject matter hereof and supersedes all
prior agreements, including but not limited to a certain Formulation Agreement
dated July 31, 2000 ,or understandings of the parties relating thereto.
11.6 Amendment. This Agreement may be modified or amended only by
written agreement of the parties hereto.
11.7 Counterparts. This Agreement may be executed in any number of
counterparts, each of which shall be deemed an original but all of which
together shall constitute a single instrument.
11.8 Governing Law. This Agreement shall be governed and construed in
accordance with the laws of the State of New York excluding any choice of law
rules which may direct the application of the law of another state.
11.9 Dispute Resolution. To the extent that a dispute arises with
respect to a term or provision of this Agreement which is not subject to a
specific time period or remedy, the parties will use all reasonable efforts to
resolve in an amicable fashion any dispute, claim or controversy that may arise
relating to the terms or performance of this Agreement. If the parties are
unable to resolve such dispute within thirty (30) days after initial notice,
either party, by notice to the other, may have such dispute referred to a senior
officer of each company. Such officers shall attempt to resolve the dispute by
good faith negotiation within thirty (30) days after receipt of such notice.
Except where clearly prevented by the area in dispute, both parties agree to
continue performing their respective obligations under this Agreement while the
dispute is being resolved.
11.10 Captions. All section titles or captions contained in this
Agreement, in any Schedule referred to herein or in any Exhibit annexed hereto,
and the table of contents, if any, to this Agreement are for convenience only,
shall not be deemed a part of this Agreement and shall not affect the meaning or
interpretation of this Agreement.
11.11 No Third-Party Rights. Except as contemplated by Section 2.2, no
provision of this Agreement shall be deemed or construed in any way to result in
the creation of any rights or obligation in any Person not a party or not
affiliated with a party to this Agreement.
22
11.12 Severability. If any provision of this Agreement is found or
declared to be invalid or unenforceable by any court or other competent
authority having jurisdiction, such finding or declaration shall not invalidate
any other provision hereof, and this Agreement shall thereafter continue in full
force and effect.
11.13 Attachments. All Schedules, Exhibits and other attachments to
this Agreement are by this reference incorporated herein and made a part of this
Agreement.
11.14 Force Majeure. In the event that a party is prevented from
carrying out its obligations under this Agreement by an event of Force Majeure,
then such party's performance of its obligations under this Agreement shall be
excused during the period of such event and for a subsequent reasonable period
of recovery; provided, however, that the party whose performance is excused
shall promptly notify the other party of the existence of such cause and shall
at all times use commercially reasonable efforts to promptly resume and complete
performance.
IN WITNESS WHEREOF, the parties have caused this Agreement to be duly
executed and delivered on the day and year first above written.
CIMA LABS INC.
By: /s/ ▇▇▇▇ ▇▇▇▇▇▇▇, Ph.D.
-----------------------------
Name: ▇▇▇▇ ▇▇▇▇▇▇▇ Ph.D.
Title: President and CEO
AVENTIS PHARMACEUTICALS, INC.
By: /s/ Sol Rajfer
-----------------------------
Name: Sol Rajfer
Title: Senior Vice President
23
SCHEDULE A TO
DEVELOPMENT AND LICENSE
AGREEMENT
DEVELOPMENT SCHEDULE
OraSolv(R) Fexofenadine Hydrochloride [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]
ANTICIPATED PRODUCT ATTRIBUTES:
o Active ingredient and potency
Fexofenadine Hydrochloride [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]
DEVELOPMENT ACTIVITIES, COSTS AND TIMING
--------------------------------------------------------------------------------
PHASE ACTIVITY TIMING COSTS($)
----- -------- ------ --------
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. FIVE PAGES
OMITTED***]
--------------------------------------------------------------------------------
24
SCHEDULE B TO
DEVELOPMENT AND LICENSE
AGREEMENT
ROYALTY RATES
Pursuant to Sections 4.3 and 4.4, AVENTIS shall pay to CIMA a
percentage of Annual Net Sales, if any, actually recorded during such Year, as
indicated on the following schedules:
All of the Territory except [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]
Net Sales of Product in the Territory Except Royalty Rate*
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION***]
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION***] of Net Sales
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION***] of Net Sales
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION***] of Net Sales
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION***]
The parties shall discuss and agree upon the royalty rate for
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***]as soon as practicable after the Effective
Date but no later than [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] prior to the
expected launch of the Product in [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]. The
agreed upon royalty rate for [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] shall
take
25
into consideration Aventis' [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]. The
parties agree that the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] as set forth
above.
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***]
26
SCHEDULE C TO
DEVELOPMENT, LICENSE
AND SUPPLY AGREEMENT
TECHNOLOGY DEVELOPMENT AND MILESTONE PAYMENTS
Pursuant to Section 4.1 (b), AVENTIS shall pay CIMA: [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION***] of the Technology Development Fee upon signature of this
Agreement and the remaining [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] within
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***] of successful completion of AVENTIS'
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***] Product. In the event, that (i) this
Agreement is terminated under 10.1 (c) or (ii) AVENTIS notifies CIMA that the
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***] were unsuccessful and AVENTIS
nevertheless desires CIMA to continue the Activities in Schedule A (which the
Parties shall amend as appropriate) Aventis shall pay CIMA the [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION***] of the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] no
later than [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***].
Pursuant to Section 4.1 (b), AVENTIS shall pay CIMA the milestone
payments set forth below (each a "Milestone Payment") within [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION***] days of completion of the research and development
milestones (each a "Milestone") set forth opposite such Milestone Payment:
Technology Development Fee: [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE
COMMISSION***]
MILESTONE ACTIVITY MILESTONE PAYMENT
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]
27
SCHEDULE D TO
DEVELOPMENT AND LICENSE
AGREEMENT
COST OF GOODS
Formulation Cost per Tablet [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION***]
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***]
*Assumptions:
1) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION***] of [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***] campaigns.
2) No costs related to the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***] are included, other than [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION***] and its release by CIMA for use in tablets.
3) AVENTIS' Packaging uses CIMA's standard [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION***] tablets per card and [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION***] cards per carton format.
28
AMENDMENT
This Amendment dated November 30, 2001 is to amend the
Development and License
Agreement between
Cima Labs Inc. ("Cima") and Aventis Pharmaceuticals Inc.
("Aventis") dated August 1, 2001 (the "
Development and License Agreement"). The
terms used in this Amendment, which are defined in the
Development and License
Agreement, shall have the same meanings as set forth therein.
Cima and Aventis hereby agree to make the following amendment to the
Development
and License Agreement:
1. In the second sentence of the first paragraph of Schedule C, the
words [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] shall
be deleted and the words [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***] shall be inserted in their place.
IN WITNESS WHEREOF, the parties have caused this Amendment to be executed by
their duly authorized representatives, effective as of the day and year first
written above.
CIMA LABS INC. AVENTIS PHARMACEUTICALS INC.
By: /s/ ▇▇▇▇ ▇. ▇▇▇▇▇▇▇ By: /s/ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇
--------------------- ---------------------------------
Name: ▇▇▇▇ ▇. ▇▇▇▇▇▇▇ Name: ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇
------------------- -------------------------------
Title: President & CEO Title: SR. VP, CORPORATE DEVELOPMENT
----------------- ------------------------------
29
AMENDMENT #2
This Amendment #2 dated December 20, 2001 is to further amend the Development
and License Agreement between
Cima Labs Inc. ("Cima") and Aventis
Pharmaceuticals Inc. ("Aventis") dated August 1, 2001, as amended by the
November 30, 2001 Amendment (the "Development and License Agreement"). The terms
used in this Amendment, which are defined in the Development and License
Agreement, shall have the same meanings as set forth therein.
Cima and Aventis hereby agree to make the following amendment to the Development
and License Agreement:
In Schedule C in the second sentence of the first paragraph the words
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION***] shall be deleted and
the words [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] shall be
inserted in their place.
In all other respects, the terms and conditions of the Development and License
Agreement shall remain in full force and effect.
IN WITNESS WHEREOF, the parties have cause this Amendment #2 to be executed by
their duly authorized representatives, effective as of the day and year first
written above.
CIMA LABS INC. AVENTIS PHARMACEUTICALS INC.
By: /s/ ▇▇▇▇ ▇▇▇▇▇ By: /s/ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
--------------- ---------------------
Name: ▇▇▇▇ ▇▇▇▇▇ Name: ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
Title: Chief Operating Officer Title: V.P., Global Business Development
30
AMENDMENT #3
This Amendment #3 dated January 18, 2002 is to further amend the Development and
License Agreement between
Cima Labs Inc. ("Cima") and Aventis Pharmaceuticals
Inc. ("Aventis") dated August 1, 2001, as amended by the November 30, 2001 and
December 19, 2001 Amendments (the "Development and License Agreement"). The
terms used in this Amendment, which are defined in the Development and License
Agreement, shall have the same meanings as set forth therein.
Cima and Aventis hereby agree to make the following amendment to the Development
and License Agreement:
1. In Schedule C in the second sentence of the first paragraph the words
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION***] shall be deleted and
the words [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] shall be
inserted in their place.
In all other respects, the terms and conditions of the Development and License
Agreement shall remain in full force and effect.
IN WITNESS WHEREOF, the parties have caused this Amendment #3 to be executed by
their duly authorized representatives, effective as of the day and year first
written above.
CIMA LABS INC. AVENTIS PHARMACEUTICALS INC.
By: /s/ ▇▇▇▇ ▇. ▇▇▇▇▇▇▇ By: /s/ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
------------------------------- --------------------------------------
18 Jan 2002 18 Jan 2002
Name: ▇▇▇▇ ▇▇▇▇▇▇▇ Name: ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
Title: Chief Executive Officer Title: V.P., Global Business Development
31
AMENDMENT #4
This Amendment #4 dated February 15, 2002 is to further amend the Development
and License Agreement between Cima Labs Inc. ("Cima") and Aventis
Pharmaceuticals Inc. ("Aventis") dated August 1, 2001 (the "Development and
License Agreement"), as amended. The terms used in this Amendment, which are
defined in the Development and License Agreement, shall have the same meanings
as set forth therein.
Cima and Aventis hereby agree to make the following amendments to the
Development and License Agreement:
1. Schedule A shall be deleted in its entirety and replaced with
Exhibit 1 attached hereto;
2. In Schedule C in the first sentence of the first paragraph the
words [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***] shall be deleted and the words [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***] shall be inserted in
their place;
3. In Schedule C in the second sentence of the first paragraph
the words [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***] no later than [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***] shall be deleted and
the words "[***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***] no later than [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***] shall be inserted in
their place; and
4. In Schedule C in the fourth line of the second paragraph the
words "Technology Development Fee: [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***]" shall be deleted and
the words "Technology Development Fee: [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***]" shall be inserted in
their place;
In all other respects, the terms and conditions of the Development and License
Agreement remain in full force and effect.
32
IN WITNESS WHEREOF, the parties have caused this Amendment #4 to be executed by
their duly authorized representatives, effective as of the day and year first
written above.
CIMA LABS INC. AVENTIS PHARMACEUTICALS INC.
By: /s/ ▇▇▇▇ ▇. ▇▇▇▇▇▇▇ By: /s/ ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
--------------------------------- ------------------------------------
15 Feb 2002 15-Feb-2002
Name: ▇▇▇▇ ▇. ▇▇▇▇▇▇▇ Name: ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
------------------------------- ----------------------------------
Title: President & CEO Title: Head, Technology Outsourcing Mgmt.
33
EXHIBIT 1
OraSolv(R)Fexofenadine Hydrochloride [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]
ANTICIPATED PRODUCT ATTRIBUTES:
o Active ingredient and potency
Fexofenadine Hydrochloride [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]
EXHIBIT 1 (Cont'd)
DEVELOPMENT ACTIVITIES, COSTS AND TIMING
------------- ------------------------------------------------------- ---------------------- ---------------------------
PHASE ACTIVITY TIMING COSTS ($)
------------- ------------------------------------------------------- ---------------------- ---------------------------
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]
------------------------------------------------------------------------------------------------------------------------