EXHIBIT 10.25
EXECUTION COPY
MASTER DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT
by and between
CIMA LABS INC.
and
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
dated as of December 18, 2001
EXHIBIT 10.25
MASTER DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT
This MASTER DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT (this "Agreement"),
dated as of December 18, 2001, is by and between CIMA LABS INC., a Delaware
corporation ("CIMA"), and [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***].
W I T N E S S E T H
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, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] is engaged, among
other things, in the business of marketing and selling of pharmaceutical
products;
WHEREAS, subject to the terms and conditions set forth in this Agreement,
CIMA and [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] wish to collaborate in the
development, registration, marketing and sale of certain prescription products;
and
WHEREAS, subject to the terms and conditions set forth in this Agreement,
CIMA wishes to license to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] and
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] wishes to license from CIMA rights to
CIMA's DuraSolv(TM), PakSolv(TM) and OraSolv(TM) technologies for use with such
prescription products.
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, manufacturing, marketing, selling
and distributing of the Products in the Territory as contemplated by this
Agreement.
EXHIBIT 10.25
"Affiliates" shall mean, with respect to any Person, any Persons 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.
"API" for each Product shall mean the active ingredient specified on
Schedule 3.1 hereto with respect to such Product.
"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, (i) the CIMA
Patents, (ii) the CIMA Technology, (iii) the CIMA Trademarks, and (iv) the CIMA
Marketing Materials.
"CIMA Marketing and Market Research Data" shall mean, with respect to the
Products, all CIMA marketing data, studies, market research data and reports
that pertain to the Products, and any further market research data that pertains
to the Products whose disclosure to [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] is not prohibited by confidentiality obligations under
agreements, dated prior to the date hereof, between CIMA and Persons who are not
Affiliates of CIMA.
"CIMA Marketing Materials" shall mean all labeling, marketing and
promotional materials and inserts currently used by CIMA that are useful in
connection with the Activities.
"CIMA Patents" shall mean United States patent nos. 6,024,981 and
6,221,392 (Rapidly Dissolving Robust Dosage Form) and any patents and patent
applications resulting therefrom, including any extension, reissue, renewal,
reexamination or continuation-in-part of such patent or patent application. To
the extent that the OraSolv(R) and PakSolv(TM) technology is used with respect
to any Product pursuant to Schedule 3.1, the term "CIMA Patents" shall, with
respect to such Product, be deemed to include United States patent nos.
5,178,878, 6,155,423, 6,269,615 and 6,311,462 and any patents and patent
applications resulting therefrom, including any extension, reissue, renewal,
reexamination or continuation-in-part of such patent or patent application.
"CIMA Technology" shall mean all of the CIMA Patents and all of CIMA's
trade secrets, technology, know-how and all other information necessary for the
manufacture of the Products including, without limitation, that relate to CIMA's
DuraSolv(R), PakSolv(TM) and OraSolv(R) technologies.
"CIMA Trademarks" shall mean the CIMA(R), DuraSolv(R), PakSolv(TM) ,
OraSolv(R) and Meltabs(R) trademarks.
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EXHIBIT 10.25
"Closing Date" shall have the meaning given in Section 6.3 hereof.
"Completion Date" shall mean, [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***].
"Cost of Goods" shall have the meaning set forth on Schedule 5.3 hereto.
"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 excluding any punitive, exemplary or consequential
damages.
"Defective" shall mean, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***].
"Development Schedule" shall mean the schedule of development activities
set forth on Schedule 3.1 hereto.
"FDA" shall mean the United States Food and Drug Administration.
"FFDCA" the United State Federal Food, Drug and Cosmetic Act, as amended
from time to time, together with any rules or regulations promulgated
thereunder.
"Force Majeure" shall mean acts of God, explosion, fire, flood, tornadoes,
thunderstorms, earthquake or tremor, war whether declared or not, terrorism,
civil strife, riots, embargo, losses or shortages of power, labor stoppage,
substance shortages, damage to or loss of product in transit, 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.
"GAAP" shall mean generally accepted accounting practices in the United
States as in effect from time to time.
"Indemnified Party" shall have the meaning given in Section 10.2 hereof.
"Indemnifying Party" shall have the meaning given in Section 10.2 hereof.
"Latent Defect" shall mean a defect that results in a recall under Section
9.3.
"Launch or Launched" shall mean, with respect to each Product, the date
when such Product is first made commercially available by [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***].
"Licensed Assets" shall have the meaning set forth in Section 2.1 hereof.
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EXHIBIT 10.25
"Net Sales" shall mean, with respect to the Products, the gross amount
invoiced to unrelated third parties for the Products in the Territory, less:
(a) trade and reasonable and customary cash discounts allowed;
(b) refunds, rebates, chargebacks, retroactive price adjustments and
any other allowances which effectively reduce the net selling price;
(c) returns, credits and allowances; and
(d) freight, taxes and insurance.
Such amounts shall be determined from books and records maintained in accordance
with GAAP, consistently applied.
"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 any of the pharmaceutical products described on
Schedule 3.1, it being understood that additional products may be added to
Schedule 3.1 after the date hereof in accordance with Section 3.4.
"Promotional Materials" shall mean any advertising and promotional
labeling bearing a name (trade name or generic name) used in the promotion of
any of the Products, including, without limitation, promotional materials
produced by or on behalf of (examples include, but are not limited to, journal
ads, brochures, service items, managed care pull through sheets, formulary
presentations, price lists, monographs, Internet pages and telephone or
television advertisements) and materials produced by outside sources (examples
include, but are not limited to, medical reprints, textbooks and CME materials)
to the extent funded by, created in cooperation with, reviewed, or distributed
by [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.***]. The definition of Promotional
Materials shall also include press releases and other releases of information to
the media regarding the Products.
"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.
"Satisfactory Completion" shall mean, [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***].
"Specifications" shall mean with respect to any Product, at any time, the
specifications for such Product that are included in the Quality Assurance
Addendum set forth on Schedule 5.4(d).
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EXHIBIT 10.25
"Territory" shall mean [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***].
"Year" shall mean a calendar year during the term of this Agreement.
SECTION 2
GRANT OF LICENSES; LICENSE OPTION
2.1 Grant of Licenses.
(a) CIMA hereby grants to [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] an exclusive license for the term of this Agreement under
the following assets to market, distribute and sell the Products, for all
indications and for all agreed upon Product line extensions, in the
Territory (such assets are referred to herein collectively as the
"Licensed Assets"):
(i) all current and future regulatory filings, approvals,
registrations and governmental authorizations that relate to the
Products in the Territory;
(ii) the CIMA Intellectual Property; and
(iii) the CIMA Marketing and Market Research Data.
(b) CIMA grants to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
an exclusive, royalty bearing license to use the CIMA Trademarks to
market, distribute and sell the Products, during the term of this
Agreement, for all indications and for all agreed upon Product line
extensions in the Territory.
(c) The license to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
will be exclusive in that CIMA will not grant any licenses of the Licensed
Assets or the CIMA Trademarks (i) in the Territory to any other Person
with respect to the Products or any other products containing the same
active ingredient [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] as any
Product or (ii) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***].
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EXHIBIT 10.25
2.2 Sublicenses. [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] shall have the
right to extend the licenses granted pursuant to this Section 2 in whole or in
part to any Affiliate of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], provided that
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] 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 [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***], and the operations of the Affiliate shall be deemed to be the
operations of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] and [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] shall account therefor and be responsible for the
performance of such Affiliate of all of its obligations hereunder. In addition,
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] 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 [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] with the prior
written consent of CIMA, which consent shall not unreasonably be withheld or
delayed.
2.3 Marketing, Distribution and Sale. After each Launch, [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] shall use its commercially reasonable efforts to
market, distribute and sell the launched 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.
SECTION 3
PRODUCT DEVELOPMENT
3.1 Obligations of CIMA. CIMA shall be responsible for the satisfactory
performance of each of the development activities set forth on Schedule 3.1 at
least by the times set forth on Schedule 3.1.
3.2 Obligations of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] shall, in a
timely fashion, supply CIMA or cause CIMA to be supplied with sufficient
quantities of API for CIMA to perform the development activities described on
Schedule 3.1 and the supply activities described in Sections 5.1 and 5.5.
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EXHIBIT 10.25
3.3 License of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Technology.
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] hereby grants to CIMA a non-exclusive
license under the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Technology so that
CIMA may carry out its obligations under Section 3.1. Such license may not be
sublicensed without the prior written consent of [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***].
3.4 Additional Products. [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] may,
with the prior written consent of CIMA, such consent not to be unreasonably
withheld, supplement Schedule 3.1 after the date hereof by adding additional
products thereto in order to increase the number of Products subject to this
Agreement or to replace any Product previously terminated under Section 11.1 (c)
or (d), in which case each such additional product(s) shall be deemed a
"Product" within the meaning hereof, provided that any Product added pursuant to
this Section 3.4 shall be subject to terms, including development schedules,
comparable to then existing Products. This Agreement shall be amended as
necessary to accommodate such additional or replacement Products and terms
related thereto.
3.5 Regulatory Matters. All Product, other than Prototypes, supplied to
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] shall be produced under cGMP and in
accordance with the Specifications. CIMA shall furnish [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] with a Certificate of Analysis with a cGMP statement to
demonstrate that each shipment of Product has been manufactured under cGMP and
other FDA guidelines and in accordance with the Specifications. In addition,
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] 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 [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] to
audit all manufacturing and processing operations at reasonable times with a
prior appointment. The right to audit shall commence with the effective date of
this Agreement. 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.
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EXHIBIT 10.25
SECTION 4
ROYALTY, COST OF GOODS AND MILESTONE PAYMENTS
4.1 Royalty and Milestone Payments.
(a) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] shall make royalty payments to
CIMA, at the times, in the amounts and subject to the conditions set forth on
Schedule 4.1(a).
(b) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] shall make Milestone Payments
and Development Fee Payments to CIMA as set forth on Schedule 4.1(b).
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***].
4.2 Records and Audit.
(a) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] and its Affiliates shall keep
full, 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 of account shall be kept at [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
principal place of business or the principal place of business of the
appropriate Affiliate of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] to which this
Agreement relates. 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 2 years after its termination, to the inspection by a firm of certified
public accountants selected by CIMA and reasonably acceptable to
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***], for the limited purpose of verifying
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] 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 3 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, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] shall promptly pay
CIMA the deficiency, plus interest at the rate of
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EXHIBIT 10.25
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] per annum, and shall reimburse CIMA for
the 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, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] 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. 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 3
Years.
(b) CIMA shall keep full, true and accurate books and records that may be
necessary for the purpose of determining the actual Costs of Goods incurred by
CIMA as contemplated hereunder. Such books and records shall be kept at CIMA's
principal place of business. Such books and records and the supporting data
shall be open, at all reasonable times and upon reasonable notice during the
term of this Agreement and for 2 years after its termination, to inspection by a
firm of certified public accountants selected by [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] and reasonably acceptable to CIMA, for the limited purpose of
verifying CIMA's Costs of Goods; provided, however, that such examination shall
not take place more often than once each Year and shall not cover more than the
preceding 3 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 [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***]. In the event that any such
inspection reveals a discrepancy between CIMA's actual Costs of Goods and that
invoiced to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], in favor of CIMA,
in excess of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of the reported
Costs of Goods for the period covered by the inspection, CIMA shall promptly pay
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] the amount of such discrepancy, plus
interest at the rate of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] per annum, and
shall reimburse [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] for the fees and
expenses paid to such accountants in connection with their inspection. In the
event that any such inspection reveals a discrepancy between CIMA's actual Costs
of Goods and that invoiced to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], in
favor of CIMA, that is less than [***CONFIDENTIAL TREATMENT
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EXHIBIT 10.25
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] of the reported Cost of Goods for the period covered by the
inspection, CIMA shall promptly pay [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] the amount of such discrepancy, plus interest at the rate of
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] per annum. 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 3 Years.
4.3 Quarterly Reports of Royalties. In any Year, [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] shall, within sixty (60) days after the end of each
Quarter, deliver to CIMA true and accurate reports, certified by an authorized
official of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], setting forth the
actual Annual Net Sales and total royalties due under Section 4.1(a) for such
Year. If no royalties are due, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] shall
so report.
4.4 Annual Reports of Costs of Goods. CIMA shall, not later than 60 days
prior to the Launch of each Product and, thereafter, not later than 60 days
after January 1 of each Year, deliver to [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] true and accurate reports, certified by an authorized official
of CIMA, setting forth in reasonable detail the information necessary to
calculate the Cost of Goods for each Product in accordance with Schedule 5.3.
Product delivered to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] between January 1
and February 28 each year shall be invoiced to [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] at the price applicable to Product delivered to [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] during the immediately preceding calendar year. Then on
or about February 28 of each year CIMA shall transmit to [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] a corrected invoice for Product delivered between
January 1 and February 28 of each year taking into account the final amount of
any such price increase or decrease, and setting forth the applicable additional
charges or credits.
4.5 Sales and Marketing Estimates. [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] shall provide CIMA with a non-binding estimate of its Annual Net
Sales by quarter for each Product [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND
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EXHIBIT 10.25
EXCHANGE COMMISSION.***] prior to the Launch of each Product. Thereafter, prior
to September 30th in any year following the Launch of such Product,
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] shall provide CIMA with non-binding
estimate of its Annual Net Sales of such Product by quarter for the following
year.
SECTION 5
SUPPLY OF PRODUCT
5.1 Supply of Product.
(a) For the term of this Agreement, or for as long as CIMA manufactures
any of the Products hereunder, whichever is shorter, [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] agrees to purchase from CIMA and CIMA agrees to supply
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] with all of [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] requirements for the Products, Product samples and Product
placebos for their subsequent use, sale, lease or transfer by [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***].
(b) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] agrees to initiate purchases of
the Products, Product samples and Product placebos hereunder by issuing CIMA
binding purchase orders not less than [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] prior to the required shipping date set forth therein. CIMA
agrees to accept any order issued in accordance with this Section 5.1(b) and to
meet the delivery dates specified thereon. All purchase orders hereunder shall
be on [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] standard purchase order form (a
copy of which is attached as Schedule 5.1(b) hereto and which shall not, for
purposes of this Agreement only, be modified in any material respect without
CIMA's prior written consent, such consent not to be unreasonably withheld or
delayed) and shall be directed to CIMA at the address set forth below. The terms
and conditions of purchase enumerated on the reverse side of such standard
purchase order form shall prevail over any inconsistent or conflicting language
as may exist on invoices, confirmation or order acknowledgment forms of CIMA,
provided, however, that in the event any terms thereof are in conflict, or are
inconsistent with any terms of this Agreement, the terms and conditions hereof
shall prevail. No Product delivered by CIMA shall have a shelf life that is more
than [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE
-11-
EXHIBIT 10.25
COMMISSION.***] less than the maximum shelf life of such Product (other than
batches that were under investigation and batches for validation which shall
have not more than [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] less than the
maximum shelf life of such Product upon delivery to [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***]).
(c) Purchase order quantities shall be in full batch sizes that are
mutually agreed by the parties.
(d) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] shall cause the amount of API
that CIMA requires to perform its obligations pursuant to Schedule 3.1 and
Sections 5.1 and 5.5 to be provided at no charge to CIMA [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] prior to date of tablet manufacture, as well as
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] of safety stock. API must conform to
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] then current raw materials
specifications. CIMA shall not be accountable for production or shipment delays
due to lack of API.
(e) EXCEPT AS SPECIFICALLY PROVIDED HEREIN, INCLUDING, WITHOUT LIMITATION,
SECTION 7.8, THE PRODUCT WILL BE SUPPLIED BY CIMA WITH NO WARRANTIES OF ANY
KIND, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE.
5.2 Identification. [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] may market the
Products under its name, with its packaging and logo; [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] will, however, identify CIMA as the supplier in a fair manner,
reasonably acceptable to CIMA. CIMA will bear all the costs of labeling the
Product so as to appropriately display the [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] name provided [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
supplies all the appropriate graphics, designs, logos and related and
appropriate artwork at least a reasonable amount of time in advance of any
Product being manufactured. [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] shall
reimburse CIMA for any reasonable and documented costs incurred by CIMA in
making changes to the packaging required to manufacture the Products in
accordance with changes to the
-12-
EXHIBIT 10.25
PDMA or other applicable law or changes required by [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***], including, but not limited to plate and die charges due to
label changes and product identification requirements, and for any packaging
components rendered obsolete by the changes. In addition, CIMA shall pay for all
initial one-time set-up charges incurred by CIMA in respect of packaging each
Product. [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] may use CIMA's name and
derivations thereof in promoting, marketing and selling the Products in the
Territory; provided, however, that the particular formulation of any reference
to CIMA's name in any Promotional Material shall be subject to CIMA's review and
consent; and provided, further, that once the formulation of any such reference
has been reviewed and consented to by CIMA, any subsequent reference to CIMA's
name using such formulation shall not be subject to the further review or
consent of CIMA. All samples shall be clearly marked "for sample use only" or
some similar phrasing suggested by [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***].
5.3 Trade, Sample and Placebo Product Price. CIMA shall supply Products,
Product samples and Product placebos to [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] at the price set forth on Schedule 5.3.
5.4 Forecasts, Delivery and Quality.
(a) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] shall provide CIMA with
12-month non-binding forecasts within 15 days after the end of each Quarter.
Such forecasts shall be revised and extended in each succeeding Quarter.
(b) Delivery of the Products, Product samples and Product placebos shall
be in accordance with the means of transportation, destination and dates set
forth in [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] purchase order. Delivery shall
be EXW (Incoterms 2000) CIMA and CIMA shall load Products on to collecting
vehicle at CIMA's risk.
(c) All deliveries of the Products hereunder shall include a Certificate
of Analysis provided by the quality control manager of CIMA attesting to the
fact that such Products (i) have been manufactured by a process which complies
with cGMP and (ii) are of quality which is in accordance with criteria
established in the Specifications and all FDA requirements.
(d) The Products, Product samples and Product placebos supplied hereunder
shall have been manufactured by a process which complies with the quality
assurance addendum set forth on Schedule 5.4(d).
-13-
EXHIBIT 10.25
5.5 Rejection and Replacement.
(a) In the event [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] determines
that any Products, Product samples or Product placebos as manufactured and/or
packaged by CIMA is Defective, then, within [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] after delivery of such Products, Product samples or Product
placebos to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] shall provide to
CIMA a written notice of rejection, specifying in reasonable detail the manner
in which the Products are Defective (the "Notice of Rejection"). If no written
Notice of Rejection is given to CIMA by [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] within such [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
period, such Products, Product samples or Product placebos shall be deemed to
have been accepted by [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***].
(b) Upon receipt of a Notice of Rejection from [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] and in order to minimize any hardship to [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] customers, CIMA shall use its reasonable best efforts
to promptly supply to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] a quantity of
replacement Products, Product samples or Product placebos meeting the
Specifications equal to the size of the lot or lots which [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] claims was Defective so that such replacement Products
shall be received by [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] within 30 days
following CIMA's receipt of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Notice
of Rejection. If CIMA agrees with [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] that
such Product is Defective then CIMA shall either replace the Defective Product
at no cost to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], or refund or
credit, as designated by [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], the price
paid for such Product plus any applicable delivery charges, including, without
limitation, shipping, insurance and taxes, and any reasonable and documented
out-of-pocket expense that [***CONFIDENTIAL TREATMENT
-14-
EXHIBIT 10.25
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] may have incurred, within thirty (30) days after written notice
from [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.***]. If CIMA disagrees with
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] as to whether such Product is Defective,
the parties shall cooperate to have the Product in dispute analyzed by an
independent testing laboratory of recognized repute jointly selected by
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] and CIMA. If the Product is determined
by such laboratory to meet the Specifications, then [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] shall bear the cost of the independent laboratory testing and
pay for the Product in accordance with this Agreement. If the Licensed Product
is determined not to have met the Specifications at time of delivery, then CIMA
shall bear the cost of the independent laboratory testing. In addition, CIMA
shall either replace the Defective Product within thirty (30) days after the
date of such determination, at no cost to [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***], or refund or credit, as designated by [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***], the price paid for such Product plus any applicable
delivery charges, including, without limitation, shipping, insurance and taxes,
and any reasonable and documented out-of-pocket expense that [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] may have incurred, within thirty (30) days after
written notice from [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]. If CIMA is unable
to replace any such Product within thirty (30) days (or at any time that CIMA
fails to deliver the replacement Product at an agreed upon date),
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] shall have the right, at its sole
discretion, to extend the timeframe for delivery of replacement Product to a
mutually agreed upon date, or, in the alternative, to require CIMA to reimburse
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] for the price paid for such Product plus
any applicable delivery charges, including, without limitation, shipping,
insurance and taxes and any reasonable and documented out-of-pocket expense
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] may have incurred. Such reimbursement
shall be made within thirty (30) days of such notice.
5.6 Invoice and Payment. Upon shipment of any Products, Product samples or
Product placebos, CIMA shall be entitled to submit invoices therefor to
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***], and [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
-15-
EXHIBIT 10.25
SECURITIES AND EXCHANGE COMMISSION.***] agrees to remit payment within thirty
(30) days from CIMA's invoice date.
5.7 Supply Disruption; Alternate Manufacturing Site.
(a) CIMA shall use its best efforts to supply [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.***] with the Products in a timely manner in
accordance with the orders and forecasts received by CIMA pursuant to
Sections 5.1(b) and 5.4(a), respectively. In any consecutive
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] period, should CIMA fail
to supply [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] with a Product
ordered for such [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] period
pursuant to Section 5.1(b) (other than for reason of Force Majeure),
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] shall have the right to
require CIMA to transfer the manufacture of such Product(s) to
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] facility or other
designated [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] facility.
Should CIMA cure its failure to supply any Product so transferred, CIMA
shall have the right to resume the manufacture of such Product and
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] and CIMA shall transfer
the manufacture of such Product back to CIMA within a commercially
reasonable amount of time.
(b) CIMA shall, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***],
establish a second manufacturing plant as an alternate FDA-approved
manufacturing site for the Products however, the second manufacturing
plant is not required to contain a bottling capability
5.8 CIMA's Obligation to Continue Manufacture. If this Agreement
terminates or expires through no breach of [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] and CIMA shall continue to supply the Products to
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] pursuant to the terms of this Agreement
until [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] from the date this Agreement is
terminated or expires pursuant to Section 11.1.
-16-
EXHIBIT 10.25
SECTION 6
CONDITIONS PRECEDENT TO THE CLOSING;
CLOSING DATE
6.1 Conditions Precedent to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
Obligations. Subject to waiver as set forth in Section 12.3, all obligations of
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] to close the transactions contemplated
under this Agreement are subject to the fulfillment or satisfaction of each of
the following conditions precedent:
(a) Representations and Warranties True as of the Closing Date. The
representations and warranties of CIMA contained in this Agreement or in
any schedule, certificate or document delivered by CIMA to
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] pursuant to the
provisions hereof shall have been true on the date hereof and shall be
true on the Closing Date with the same effect as though such
representations and warranties were made as of such date.
(b) Compliance with this Agreement. CIMA shall have performed and
complied with all agreements and conditions required by this Agreement to
be performed or complied with by it prior to or by the Closing Date.
(c) Closing Certificate. [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] shall have received a certificate from CIMA, executed by
an officer of CIMA, certifying in such detail as [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.***] may reasonably request that the conditions
specified in Sections 6.1(a) and 6.1(b), above, have been fulfilled and
certifying that CIMA has obtained all consents and approvals required
hereunder.
(d) No Threatened or Pending Litigation. On the Closing Date, no
suit, action or other proceeding, or injunction or final judgment relating
thereto, shall, to the best of CIMA's knowledge, be threatened or be
pending before any court or governmental or regulatory official, body or
authority in which it is sought to restrain or prohibit or to obtain
damages or other relief in connection with this Agreement or the
consummation of the transactions contemplated hereby, and no investigation
that might result in any such suit, action or proceeding shall be pending
or, to the best of CIMA's knowledge, threatened.
6.2 Conditions Precedent to CIMA's Obligations. Subject to waiver as set
forth in Section 12.3, all obligations of CIMA to close the transactions
contemplated under this
-17-
EXHIBIT 10.25
Agreement are subject to the fulfillment or satisfaction of each of the
following conditions precedent:
(a) Representations and Warranties True as of the Closing Date. The
representations and warranties of [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] contained in this Agreement or in any schedule,
certificate or document delivered by [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] to CIMA pursuant to the provisions hereof shall have been
true on the date hereof and shall be true on the Closing Date with the
same effect as though such representations and warranties were made as of
such date.
(b) Compliance with this Agreement. [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] shall have performed and complied with all
agreements and conditions required by this Agreement to be performed or
complied with by it prior to or by the Closing Date.
(c) Closing Certificate. CIMA shall have received a certificate from
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***], executed by an officer
of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***], certifying in such
detail as CIMA may reasonably request that the conditions specified in
Sections 6.2(a) and 6.2(b), above, have been fulfilled and certifying that
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] has obtained all consents
and approvals required hereunder.
(d) No Threatened or Pending Litigation. On the Closing Date, no
suit, action or other proceeding, or injunction or final judgment relating
thereto, shall, to the best of [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] knowledge, be threatened or be pending before any court or
governmental or regulatory official, body or authority in which it is
sought to restrain or prohibit or to obtain damages or other relief in
connection with this Agreement or the consummation of the transactions
contemplated hereby, and no investigation that might result in any such
suit, action or proceeding shall be pending or, to the best of
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] knowledge, threatened.
-18-
EXHIBIT 10.25
6.3 Closing Date.
(a) Subject to Section 6.3(b), below, the closing of the
transactions contemplated by this Agreement shall take place at 10:00
a.m., local time, on December 18, 2001, or on such other date as may be
mutually agreed upon in writing by the parties (the "Closing Date"), at
the offices of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***].
(b) Each party hereby agrees to use its best efforts to consummate
the transactions contemplated herein, as modified, on or before December
18, 2001; provided, however, that if the parties are unable to close the
transactions contemplated hereby by January 31, 2002, or such later date
as shall be mutually agreed to in writing by CIMA and [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.***], then all of the rights and obligations of
the parties under this Agreement shall terminate without liability.
SECTION 7
REPRESENTATIONS AND WARRANTIES OF CIMA
CIMA hereby represents and warrants to [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] that:
7.1 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 and
the CIMA Trademarks to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] pursuant
hereto.
7.2 Due Authority; No Breach. The execution, delivery and performance by
CIMA of this Agreement and each agreement or instrument contemplated by this
Agreement, and the performance of the transactions contemplated hereby and
thereby, have been duly authorized by all necessary corporate action by CIMA.
This Agreement is, and each agreement or instrument contemplated by this
Agreement, when executed and delivered by CIMA in accordance with the provisions
hereof, will be (assuming the due execution and delivery hereof and thereof by
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***]) the legal, valid and binding obligation
of CIMA, in each case enforceable against CIMA in accordance with its terms,
except as such enforceability may be limited by applicable bankruptcy,
insolvency, moratorium, reorganization, or similar laws from time to time in
effect which affect the enforcement of creditors' rights generally and by legal
and equitable limitations on the availability of specific performance and other
equitable remedies against CIMA. All persons
-19-
EXHIBIT 10.25
who have executed this Agreement on behalf of CIMA, or who will execute on
behalf of CIMA any agreement or instrument contemplated by this Agreement, have
been duly authorized to do so by all necessary corporate action. Neither the
execution and delivery of this Agreement or any such other agreement or
instrument by CIMA, nor the performance of the obligations contemplated hereby
or thereby, 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
or under any agreement or instrument contemplated hereby.
7.3 Intellectual Property. CIMA is the lawful owner of the Licensed Assets
and CIMA Trademarks, CIMA can license the Licensed Assets and CIMA Trademarks
without the consent of any third party in the Territory, there is no pending or
overtly threatened claim against CIMA asserting that any of the Licensed Assets
or CIMA Trademarks infringes or violates the rights of third parties in the
Territory or that [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], by practicing under
the Licensed Assets and CIMA Trademarks in performing the Activities, would
violate any of the intellectual property rights of any third party in the
Territory, 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 and
CIMA Trademarks infringes or violates the right of third parties in the
Territory. CIMA has not given any notice to any third parties asserting
infringement by such third parties upon any of the Licensed Assets and CIMA
Trademarks. CIMA is not aware of and has not received any communications
challenging the ownership, validity or effectiveness of any of the Licensed
Assets and CIMA Trademarks. 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 [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] pursuant to this
Agreement.
7.4 Technology Rights. The CIMA Technology, to the best of CIMA's
knowledge, when combined with the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
Technology, includes all the technology, patents, know-how, trade secrets and
other intellectual property necessary to manufacture the Products.
7.5 Litigation. There are no pending or, to the best of CIMA's knowledge,
threatened judicial, administrative or arbitral actions, claims, suits or
proceedings pending as of the date hereof against CIMA relating to the
Activities, the Licensed Assets or the CIMA Trademarks which, either
individually or together with any other, would have a material adverse effect on
the
-20-
EXHIBIT 10.25
Activities, the Licensed Assets, the CIMA Trademarks or the ability of CIMA to
perform its obligations under this Agreement or any agreement or instrument
contemplated hereby. There are no pending, and CIMA does not presently
contemplate bringing, any actions or suits relating to the Activities, the
Licensed Assets or the CIMA Trademarks against others.
7.6 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, delivery and performance
of this Agreement, or any agreement or instrument contemplated by this
Agreement, by CIMA or the performance by CIMA of its obligations contemplated
hereby and thereby.
7.7 Brokerage. No broker, finder or similar agent has been employed by or
on behalf of CIMA, and no Person with which CIMA has had any dealings or
communications of any kind is entitled to any brokerage commission, finder's fee
or any similar compensation, in connection with this Agreement or the
transactions contemplated hereby.
7.8 Supply. All finished Products supplied by CIMA under Section 5 shall
(i) have been manufactured by a process which complies with cGMP and the Quality
Assurance Addendum set forth on Schedule 5.4(d) and (ii) be of a quality which
is in accordance with criteria established by the specifications established by
the Specifications and all FDA requirements.
SECTION 8
REPRESENTATIONS AND WARRANTIES OF [***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.***] represents and warrants to CIMA
that:
8.1 Organization, Power and Authority. [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] is a corporation duly organized, validly existing and in good
standing under the laws of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] has all
necessary corporate power and authority to enter into, and be bound by the terms
and conditions of, this Agreement, to license the Licensed Assets, the Patents
and the CIMA Technology from CIMA, and to license the [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] Technology to CIMA pursuant hereto.
8.2 Due Authority; No Breach. The execution, delivery and performance by
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] of this
-21-
EXHIBIT 10.25
Agreement, and each agreement or instrument contemplated by this Agreement, and
the performance of the transactions contemplated hereby and thereby, have been
duly authorized by all necessary corporate action by [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***]. This Agreement is, and each agreement or instrument
contemplated by this Agreement, when executed and delivered by [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] in accordance with the provisions hereof, will be
(assuming due execution and delivery hereof and thereof by CIMA) the legal,
valid and binding obligation of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], in
each case enforceable against [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] in
accordance with its terms, except as such enforceability may be limited by
applicable bankruptcy, insolvency, moratorium, reorganization, or similar laws
from time to time in effect which affect the enforcement of creditors' rights
generally and by legal and equitable limitations on the availability of specific
performance and other equitable remedies against [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***]. All persons who have executed this Agreement on behalf of
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***], or who will execute on behalf of
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] any agreement or instrument contemplated
by this Agreement, have been duly authorized to do so by all necessary corporate
action. Neither the execution and delivery of this Agreement by [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***], or any such other agreement or instrument by
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***], nor the performance of the obligations
contemplated hereby and thereby, 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 [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] 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,
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] or upon the securities, property or
business of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], or (iii) constitute
a violation by [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of any applicable
law or regulation of any jurisdiction as such law or regulation relates to
[***CONFIDENTIAL TREATMENT
-22-
EXHIBIT 10.25
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] or to the property or business of [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***], except for such conflict, acceleration, default, breach or
violation that is not reasonably likely to have a material adverse effect on
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***]'s ability to perform its obligations
under this Agreement or any agreement or instrument contemplated hereby.
8.3 Brokerage. No broker, finder or similar agent has been employed by or
on behalf of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] and no Person with
which [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] has had any dealings or
communications of any kind is entitled to any brokerage commission, finder's fee
or any similar compensation, in connection with this Agreement or the
transactions contemplated hereby.
8.4 Litigation. There are no pending or, to the best of [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***]'s knowledge, threatened judicial, administrative or
arbitral actions, claims, suits or proceedings pending as of the date hereof
against [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] which, either individually or
together with any other, will have a material adverse effect on the ability of
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] to perform its obligations under this
Agreement or any agreement or instrument contemplated hereby or affect adversely
the grant to CIMA of the non-exclusive license of the [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] Technology pursuant to Section 3.3.
8.5 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, delivery and performance
of this Agreement, or any agreement or instrument contemplated by this
Agreement, by [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] or the performance
by [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.***] of its obligations contemplated
hereby and thereby.
-23-
EXHIBIT 10.25
SECTION 9
ADDITIONAL COVENANTS AND AGREEMENTS OF THE PARTIES
9.1 Governmental Filings. CIMA and [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] 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 Products and to cooperate
with one another as reasonably necessary to accomplish the foregoing.
9.2 Compliance with Law. [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] and
CIMA shall each comply with all federal, state and local laws and regulations
applicable to developing, approving, manufacturing, marketing and selling the
Products in the Territory, the Licensed Assets, the Patents and the Technology
or the performance of their respective obligations hereunder. CIMA and
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] 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 [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] 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 any Product.
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] 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. [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] 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 [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] shall be responsible for deciding the appropriate form
and content of any response with respect to any of its cited activities.
9.3 Recall. [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] and CIMA shall
consult with one another as to all decisions concerning recall or withdrawal of
any Product from the market, including, but not limited to, determining
-24-
EXHIBIT 10.25
whether or not to make any such recall or withdrawal, the timing and scope
thereof, and the means of conducting any recall or withdrawal. The party
requesting any recall or withdrawal must receive the prior written consent of
the other party, such consent not to be unreasonably withheld, prior to
initiating such recall or withdrawal. No consent shall be necessary if the
recall or withdrawal is requested by the FDA or other governmental authority.
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***]. The costs for any other recall or
withdrawal shall be the responsibility of [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***].
9.4 Confidentiality. [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] shall treat as
confidential the Licensed Assets, the Patents, the CIMA Technology, and all
other information of CIMA of which [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
becomes aware in connection with this Agreement (collectively, "CIMA Proprietary
Information"). [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] 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 the [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] Technology and all other information of [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] of which CIMA becomes aware in connection with this
Agreement (collectively, "[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Proprietary
Information"). CIMA shall neither disclose [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] Proprietary Information to any third party nor use
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] 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;
-25-
EXHIBIT 10.25
(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;
(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.
Nothing in the foregoing, however, shall prohibit a party from making such
disclosures to the extent deemed necessary under applicable federal or state
securities laws or any applicable rule or regulation of any nationally
recognized securities exchange including, without limitation, NASDAQ. In such
event, however, the disclosing party shall use good faith efforts to consult
with the other party prior to such disclosure and, where applicable, shall
request confidential treatment to the extent available. [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] 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 [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] Proprietary Information except as set forth in this Agreement.
9.5 Expenses. CIMA and [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] 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.
9.6 Reasonable Efforts. CIMA and [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] each hereby agrees to use all reasonable efforts to take, or
cause to be taken, all actions and to do, or cause to be done all things
necessary or proper to make effective the transactions contemplated by this
Agreement, including such actions as may be reasonably necessary to obtain
approvals and consents of governmental Persons and other Persons.
9.7 Publicity. Each of the parties agrees 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, 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.
-26-
EXHIBIT 10.25
9.8 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 Products or any of the Licensed
Assets, the Patents or the Technology, 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, provided that, for purposes of this provision,
reasonable efforts to make available any employee shall be deemed to mean
providing a party with reasonable access to any such employee at no cost for a
period of time not to exceed 24 hours (e.g., three 8-hour business days).
Thereafter, any such employee shall be made available for such time and upon
such terms and conditions (including, but not limited to, compensation) as the
parties may mutually agree.
9.9 Competition; No Sale for Resale.
(a) CIMA agrees that, commencing on the Closing Date and continuing
for the period ending [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
after the term of this Agreement, it shall not directly or indirectly,
develop or manufacture for sale within the Territory any Product described
on Schedule 3.1 on the date hereof or engage in the marketing, selling or
distributing of any such Product in the Territory except as contemplated
by this Agreement. It is further understood that the remedies at law are
inadequate in the case of any breach of this covenant and that
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] shall be entitled to
equitable relief, including the remedy of specific performance, with
respect to any breach of such covenant.
(b) Neither [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] nor any
sublicensee of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] shall
knowingly directly or indirectly sell any Product to anyone in the
Territory for subsequent distribution or resale outside the Territory and
each shall take all reasonable precautions to prevent such distribution or
resale outside the Territory. Neither CIMA nor any of its Affiliates shall
knowingly directly or indirectly sell any Product to anyone in the
Territory or outside the Territory for subsequent distribution or resale
in the Territory and each shall take all reasonable precautions to prevent
such distribution or resale in the Territory.
9.10 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 [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] pursuant to this
Agreement.
-27-
EXHIBIT 10.25
9.11 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. [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***].
(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, [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] shall have no rights to use the CIMA Trademarks.
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] will not use in its
business, in or outside of the Territory, any other xxxx or name which is
similar to or nearly resembles any of the CIMA Trademarks in use by CIMA
to indicate the source and origin of the CIMA Technology as to be likely
to cause deception or confusion. [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] recognizes that CIMA is the owner of all CIMA Trademarks
used in commerce to indicate the source of the CIMA Technology and agrees
that the CIMA Trademarks shall remain vested in CIMA both during the term
of this Agreement and thereafter. [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] shall not contest the validity of the CIMA Trademarks or
CIMA's ownership of the CIMA Trademarks. Use of the CIMA Trademarks by
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] in conjunction with the
manufacture, use, and sale 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) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] shall be
solely responsible for filing, prosecuting, and maintaining all trademarks
it develops or owns for the Products (the "[***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] Trademarks"), and [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] shall pay the costs associated therewith. All
registrations, variations, logos, goodwill and other rights under or
acquired through use of the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
Trademarks shall accrue and belong to [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED
-28-
EXHIBIT 10.25
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]. CIMA
shall have no rights to use the [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] Trademarks, including, without limitation, in connection
with any product subsequently developed by CIMA. CIMA will not use in its
business, in or outside of the Territory, any other xxxx or name which is
similar to or nearly resembles the [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] Trademarks in use by [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] in a manner that is likely to cause deception or
confusion. CIMA recognizes that [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] is the owner of all of the [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] Trademarks used in commerce to indicate the
source of the Product and agrees that the [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] Trademarks shall remain vested in
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] both during the term of
this Agreement and thereafter. CIMA shall not contest the validity of the
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Trademarks or
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] ownership of the
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Trademarks. Use of the
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Trademarks by
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] in conjunction with the
manufacture, use, and sale of the Product and all goodwill related thereto
shall inure to the benefit of [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] for purposes of building the longevity and extent of use
of the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Trademarks.
(d) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] and CIMA agree
that, where applicable, all packaging of the Products shall identify (i)
the number of the CIMA Patents and CIMA as the owner thereof and (ii)
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION
-29-
EXHIBIT 10.25
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
as the owner of the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
Trademarks.
(e) Any improvements to the CIMA Technology (whether or not
patentable) shall be owned solely by CIMA.
(f) Any improvements to the [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] Technology (whether or not patentable) shall be owned
solely by [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***].
(g) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] shall have
full ownership rights to the Products with the exception of any
improvements to the CIMA Technology as contemplated by Section 9.11(e).
(h) Any provisions in this Agreement to the contrary
notwithstanding, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
acknowledges that, for all purposes, CIMA is the owner of the CIMA
Technology and CIMA acknowledges that, for all purposes, [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.***] is the owner of the [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.***] Technology.
9.12 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. [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***].
In the event that CIMA does not bring suit against such third party
infringer, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] 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 9.12(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
-30-
EXHIBIT 10.25
such suit. In the event of any infringement suit against a third party
brought by either party pursuant to this Section 9.12, 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.
(c) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***].
9.13 Supply of Products. CIMA shall maintain sufficient capacity
throughout the term of this Agreement to meet the requirements of
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] for the supply of Products hereunder.
9.14 Liability Insurance. At and after each Launch, CIMA shall use its
best efforts to obtain and carry in full force and effect product liability
insurance in respect of the applicable Product in the amount of $1,000,000 per
occurrence and in the aggregate and policies of $10,000,000 of excess coverage
in the aggregate. At and after each Launch, [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] shall use its best efforts to obtain and carry in full force and
effect product liability insurance in respect of the applicable Product in the
amount of $1,000,000 per occurrence and in the aggregate and policies of
$10,000,000 of excess coverage in the aggregate.
9.15 Referral of Orders and Inquiries. CIMA shall refer all Persons
sending orders or making inquiries regarding the Products within the Territory
to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.***] and shall promptly notify
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] of the name of each such Person and the
nature of the inquiry of such Person.
9.16 Deemed Breach of Covenant. Neither CIMA nor [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] shall be deemed to be in breach of any covenant
contained in this Section 9 if such party's deemed breach is the result of any
action or inaction on the part of the other party.
-31-
EXHIBIT 10.25
SECTION 10
INDEMNIFICATION
10.1 Indemnification.
(a) CIMA shall indemnify, defend and hold [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] (and its directors, officers, employees, and Affiliates)
harmless from and against any and all Damages incurred or suffered by
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] (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 or any agreement, instrument or document delivered
by CIMA pursuant to the terms of this Agreement;
(ii) any failure to perform duly and punctually any covenant,
agreement or undertaking on the part of CIMA contained in this
Agreement;
(iii) any act or omission of CIMA with respect to the
operation of CIMA's business, or the handling, manufacturing or
development of the Products by CIMA; or
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***].
(b) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] 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:
(i) any breach of any representation or warranty made by
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] in this
Agreement or any agreement, instrument or document delivered by
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] pursuant
to the terms of this Agreement;
(ii) any failure to perform duly and punctually any covenant,
agreement or undertaking on the part of [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] contained in this Agreement; or
-32-
EXHIBIT 10.25
(iii) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
with respect to the operation of [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] business or the handling, marketing or sale
of the Products by [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***], including [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] supply of API hereunder.
10.2 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 10.1. 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 10.2, (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
-33-
EXHIBIT 10.25
dispose of any claim without the prior written consent of the Indemnified Party
(which consent shall not be unreasonably withheld).
10.3 [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***].
10.5 Indemnification Payment. Upon the final determination of liability
and the amount of the indemnification payment under this Section 10, the
appropriate party shall pay to the other, as the case may be, within 10 business
days after such determination, the amount of any claim for indemnification made
hereunder.
10.6 Survival. The provisions of Section 10 shall survive any termination
of this Agreement. [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***].
SECTION 11
TERMINATION
11.1 Termination. The term of this Agreement shall begin upon the Closing
Date and, unless sooner terminated as hereinafter provided, shall end with
respect to each Product upon the expiration of the last CIMA Patent applicable
to such Product to expire or, if later, the expiration of any other patent
resulting from the development process contemplated hereby. Notwithstanding the
foregoing, this Agreement may be terminated as follows:
(a) Termination for Insolvency. If either [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] 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. [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] 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
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
-34-
EXHIBIT 10.25
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
11.1(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 [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] after
receipt of notification, then such party immediately may terminate this
Agreement. This Section 11.1(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.
(c) Unilateral Termination by [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] Prior to Launch. Prior to the Launch of any Product,
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] will have the right to
unilaterally terminate this Agreement either in its entirety or with
respect to one or more specific Products at any time and in its sole
discretion upon the delivery of written notice to CIMA. Any provision
herein notwithstanding, in the event that [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] terminates this Agreement pursuant to this
Section 11.1(c), [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] sole
obligation under this Agreement shall be to reimburse CIMA for the costs
and expenses actually incurred by CIMA (i) in performing the development
activities set forth on Schedule 4.1(b) hereto in respect of such
terminated Product(s) prior to CIMA's receipt of such notice of
termination and (ii) in connection with the orderly close out of such
development activities; provided, however, that [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] reimbursement obligations pursuant to this
Section 11.1(c) in respect of any terminated Product(s) shall exclude the
costs and expenses incurred by CIMA in connection with any Development
Phase for which [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] has made
a Development Fee Payment and shall in no event exceed the Development Fee
Payment associated with the Development Phase on which CIMA is then
working, as set forth on Schedule 4.1(b).
(d) Unilateral Termination by [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] After Launch. Following the Launch of any Product,
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] will have the right to
unilaterally terminate this Agreement either in its entirety or with
respect to one or more specific Products and in its sole discretion upon
the delivery of written notice to CIMA. Termination of the
-35-
EXHIBIT 10.25
Agreement either in its entirety or with respect to one or more specific
Products will be effective with respect to such Product or Products
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] following such written
notice to CIMA.
(e) Continuing Obligations. Termination of this Agreement for any
reason shall not relieve the parties of any obligation accruing prior
thereto with respect to any Product and any ongoing obligations hereunder
with respect to the remaining Products 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 5.8, 9.3, 9.4, 9.5, 9.7, 9.9(a), 10,
11.1(c), 11.1(d), 11.1(e) and 12 hereof, and such obligations shall
survive any such termination.
SECTION 12
MISCELLANEOUS
12.1 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 [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] 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 in the event that a third party acquires substantially all of the
assets or outstanding shares of, or merges with, [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] or CIMA, as the case may be.
12.2 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
00000 Xxxxxx Xxxx Xxxx
Xxxx Xxxxxxx, XX 00000
Facsimile: 000-000-0000
Attention: Chief Executive Officer
-36-
EXHIBIT 10.25
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
or in any case to such other address or addresses as hereafter shall be
furnished as provided in this Section 12.2 by any party hereto to the other
party.
12.3 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
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] 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 [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] 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 privilege hereunder preclude any other or further exercise thereof or the
exercise of any other right, power or privilege hereunder. The indemnification
provided in Section 10 shall be the sole remedy available for any Damages
arising out of or in connection with this Agreement except for any rights or
remedies which the parties hereto may otherwise have in equity.
12.4 Survival of Representations. Each of the representations and
warranties made in this Agreement shall continue for the term of this Agreement
and shall thereafter be extinguished.
12.5 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. [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] acknowledges that it does not have, and
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] shall not make representations to any
third party, either directly or indirectly, indicating that [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] 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
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] or to obligate [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] in any way whatsoever.
12.6 Entire Agreement. This Agreement constitutes the entire agreement
between the parties with respect to the subject matter hereof and supersedes all
prior agreements including,
-37-
EXHIBIT 10.25
without limitation the Feasibility Agreement entered by CIMA and
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] on November 30, 2001, or understandings
of the parties relating thereto.
12.7 Amendment. This Agreement may be modified or amended only by written
agreement of the parties hereto.
12.8 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.
12.9 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.
12.10 Arbitration. Any dispute, controversy or claim arising out of or in
connection with this Agreement shall be determined and settled by arbitration in
New York, New York, pursuant to the Rules of Arbitration then in effect of the
American Arbitration Association. Any award rendered shall be final and
conclusive upon the parties and a judgment thereon may be entered in a court
having competent jurisdiction. Any arbitration hereunder shall be (i) submitted
to an arbitration tribunal comprised of three (3) independent members
knowledgeable in the pharmaceutical industry, one of whom shall be selected by
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***], one of whom shall be selected by CIMA,
and one of whom shall be selected by the other two arbitrators; (ii) allow for
the parties to request discovery pursuant to the rules then in effect under the
Federal Rules of Civil Procedure for a period not to exceed 90 days; and (iii)
require the award to be accompanied by findings of fact and a statement of
reasons for the decision. Each party shall bear its own costs and expenses,
including attorney's fees incurred in any dispute which is determined and/or
settled by arbitration pursuant to this Section. 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.
Arbitration shall not prevent any party from seeking injunctive relief where
such remedy is an appropriate form of remedy under the circumstances.
12.11 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.
12.12 No Third-Party Rights. 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.
12.13 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
-38-
EXHIBIT 10.25
declaration shall not invalidate any other provision hereof, and this Agreement
shall thereafter continue in full force and effect.
12.14 Attachments. All Schedules, Exhibits and other attachments to this
Agreement are by this reference incorporated herein and made a part of this
Agreement.
12.15 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.
12.16 Consents. Where this Agreement requires the consent of any party and
specifies that such consent is not to be unreasonably withheld, the
determination of whether such consent may be withheld shall be based upon the
facts and circumstances of the business of the party whose consent is requested,
it being understood that it is reasonable to withhold the requested consent if
granting the requested consent would have an adverse impact on such party's
business activities.
-39-
EXHIBIT 10.25
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:
----------------------------------------
Name:
Title:
[***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***]
By: [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***]
EXHIBIT 10.25
Schedule 3.1 to
Master Development,
License and Supply Agreement
Master Development Schedule
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***]
EXHIBIT 10.25
Schedule 4.1(a) to
Master Development,
License and Supply Agreement
Royalty Rates
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***].
EXHIBIT 10.25
Schedule 4.1(b) to
Master Development,
License and Supply Agreement
Development Fee And Milestone Payments
(a) Subject to paragraph (b) of this Schedule 4.1(b), [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] shall pay to CIMA any of the milestone payments set
forth below (each a "Milestone Payment") promptly after CIMA demonstrates the
Satisfactory Completion (as defined below) of the research and development
phases (each a "Development Phase") set forth opposite such Milestone Payment:
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***]
(b) Promptly after the completion of each Development Phase, CIMA shall
notify [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of such completion and shall
provide [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] sufficient written materials (a
"Development Phase Notice") to allow [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] to evaluate whether or not such Development Phase has been
Satisfactorily Completed. [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***].
(c) In addition to the Milestone Payments described above, in connection
with each Product, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] shall pay CIMA an
amount equal to (i) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] in the event the
actual Completion Date for such Product precedes the target Completion Date
therefor set forth on Schedule 3.1 by at least [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] or (ii) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] in the event
the actual Completion Date for such Product precedes the target Completion Date
therefor set forth on Schedule 3.1 by at least [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***].
(d) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
EXHIBIT 10.25
shall also pay to CIMA the development fee payments set forth below (each a
"Development Fee Payment") within thirty (30) days of CIMA's invoice for
development work performed in accordance with this Agreement during the
applicable Quarter.
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
EXHIBIT 10.25
Schedule 5.1(b) to
Master Development
License and Supply Agreement
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
Purchase Order
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
EXHIBIT 10.25
Schedule 5.3 to
Master Development,
License and Supply Agreement
Cost of Goods
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***]
EXHIBIT 10.25
Schedule 5.4(d) to
Master Development
License and Supply Agreement
Quality Assurance Addendum
[To be mutually agreed by parties on
or prior to each Launch]
EXHIBIT 10.25
TABLE OF CONTENTS
PAGE
SECTION 1 DEFINITIONS................................................. 1
SECTION 2 GRANT OF LICENSES; LICENSE OPTION........................... 5
2.1 Grant of Licenses.............................................. 5
2.2 Sublicenses.................................................... 6
2.3 Marketing, Distribution and Sale............................... 6
SECTION 3 PRODUCT DEVELOPMENT......................................... 6
3.1 Obligations of CIMA............................................ 6
3.2 Obligations of [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.***] 7
3.3 License of [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.***] Technology 7
3.4 Additional Products............................................ 7
3.5 Regulatory Matters............................................. 7
SECTION 4 ROYALTY, COST OF GOODS AND MILESTONE PAYMENTS............... 7
4.1 Royalty and Milestone Payments................................. 7
4.2 Records and Audit.............................................. 8
4.3 Quarterly Reports of Royalties................................. 9
4.4 Annual Reports of Costs of Goods............................... 9
4.5 Sales and Marketing Estimates.................................. 9
SECTION 5 SUPPLY OF PRODUCT........................................... 9
5.1 Supply of Product.............................................. 9
5.2 Identification................................................. 10
5.3 Trade, Sample and Placebo Product Price........................ 11
5.4 Forecasts, Delivery and Quality................................ 11
5.5 Rejection and Replacement...................................... 11
5.6 Invoice and Payment............................................ 12
5.7 Supply Disruption; Alternate Manufacturing Site................ 12
5.8 CIMA's Obligation to Continue Manufacture...................... 12
SECTION 6 CONDITIONS PRECEDENT TO THE CLOSING; CLOSING DATE........... 13
-i-
EXHIBIT 10.25
TABLE OF CONTENTS
(continued)
PAGE
6.1 Conditions Precedent to [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.***] Obligations 13
6.2 Conditions Precedent to CIMA's Obligations..................... 13
6.3 Closing Date................................................... 14
SECTION 7 REPRESENTATIONS AND WARRANTIES OF CIMA...................... 14
7.1 Organization, Power and Authority.............................. 14
7.2 Due Authority; No Breach....................................... 15
7.3 Intellectual Property.......................................... 15
7.4 Technology Rights.............................................. 15
7.5 Litigation..................................................... 16
7.6 Governmental Approval.......................................... 16
7.7 Brokerage...................................................... 16
7.8 Supply......................................................... 16
SECTION 8 REPRESENTATIONS AND WARRANTIES OF [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] 16
8.1 Organization, Power and Authority.............................. 16
8.2 Due Authority; No Breach....................................... 16
8.3 Brokerage...................................................... 17
8.4 Litigation..................................................... 17
8.5 Governmental Approval.......................................... 17
SECTION 9 ADDITIONAL COVENANTS AND AGREEMENTS OF THE PARTIES.......... 17
9.1 Governmental Filings........................................... 17
9.2 Compliance with Law............................................ 18
9.3 Recall......................................................... 18
9.4 Confidentiality................................................ 18
9.5 Expenses....................................................... 19
9.6 Reasonable Efforts............................................. 19
9.7 Publicity...................................................... 19
-ii-
EXHIBIT 10.25
TABLE OF CONTENTS
(continued)
PAGE
9.8 Cooperation.................................................... 19
9.9 Competition; No Sale for Resale................................ 20
9.10 Conflicting Rights............................................. 20
9.11 Patent and Trademark Maintenance............................... 20
9.12 Infringement; Enforcement of Proprietary Rights................ 22
9.13 Supply of Products............................................. 22
9.14 Liability Insurance............................................ 22
9.15 Referral of Orders and Inquiries............................... 22
9.16 Deemed Breach of Covenant...................................... 23
SECTION 10 INDEMNIFICATION............................................. 23
10.1 Indemnification................................................ 23
10.2 Notice and Opportunity To Defend............................... 23
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
10.5 Indemnification Payment........................................ 25
10.6 Survival....................................................... 25
SECTION 11 TERMINATION................................................. 25
11.1 Termination.................................................... 25
SECTION 12 MISCELLANEOUS............................................... 27
12.1 Successors and Assigns......................................... 27
12.2 Notices........................................................ 27
12.3 Waiver; Remedies............................................... 28
12.4 Survival of Representations.................................... 28
12.5 Independent Contractors........................................ 28
12.6 Entire Agreement............................................... 28
12.7 Amendment...................................................... 28
12.8 Counterparts................................................... 28
12.9 Governing Law.................................................. 28
12.10 Arbitration.................................................... 28
12.11 Captions....................................................... 29
-iii-
EXHIBIT 10.25
TABLE OF CONTENTS
(continued)
PAGE
12.12 No Third-Party Rights.......................................... 29
12.13 Severability................................................... 29
12.14 Attachments.................................................... 29
12.15 Force Majeure.................................................. 29
12.16 Consents....................................................... 29
SCHEDULES
Schedule 3.1 Master Development Schedule
Schedule 4.1(a) Royalty Rates
Schedule 4.1(b) Development Fee and Milestone Payments
Schedule 5.1(b) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
Purchase Order
Schedule 5.3 Cost of Goods
Schedule 5.4(d) Quality Assurance Addendum
-iv-
