EXHIBIT 10.1
DEVELOPMENT, COMMERCIALIZATION AND LICENSE AGREEMENT
BETWEEN
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
AND
CIMA LABS INC.
This DEVELOPMENT, COMMERCIALIZATION AND LICENSE AGREEMENT (the
"Agreement"), effective as of June 26, 2003 (the "Effective Date"), by and
between [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***], a Delaware corporation and
wholly owned subsidiary of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], maintaining
its offices at [***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.***]"), and CIMA LABS INC., a Delaware Corporation,
maintaining offices at 00000 Xxxxxx Xxxx Xxxx, Xxxx Xxxxxxx, XX 00000-0000
("CIMA").
In consideration of the rights conferred and the obligations assumed herein, and
intending to be legally bound, the parties agree as follows:
1. DEFINITIONS
As used in this Agreement, the following capitalized terms shall have
the meanings set out below:
1.1. "Affiliate(s)" shall mean, in relation to either party hereto,
any entity or person which directly or indirectly controls, is
controlled by, or is under common control by a party. The term
"control" for purposes of this definition shall mean the right
to exercise more than fifty percent (50%) of the voting rights
of an entity, or the power to direct or cause the direction of
the management or policies, or to direct, select, or appoint
officers or directors of the entity.
1.2. "[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
Confidential Information" has the meaning ascribed to it in
Section 9.1
1.3. "CIMA Competitor" shall mean any entity or person principally
engaged in the business of licensing, formulation, development
and manufacturing of fast Oral Disintegrating Tablets and
listed on Schedule 1.3 hereto and as such schedule may be
amended by mutual agreement from time to time.
1.4. "CIMA Confidential Information" has the meaning ascribed to it
in Section 9.2.
1.5. "CIMA Licensed Patents" shall mean the patents and patent
applications owned or Controlled by CIMA and/or its Affiliates
that claim Licensed Product, the DuraSolv(R) Technology, the
PakSolv(R) Technology and/or the OraSolv(R) Technology as
related to Licensed Product, and its manufacture, its
packaging, or its use, its import or its sale and including
any extension, reissue, renewal, reexamination or
continuation-in-part of such patents or patent applications.
CIMA Licensed Patents shall include Developed Intellectual
Property. CIMA Licensed Patents shall not include any Work
Product. The initial list of CIMA Licensed Patents is set
forth on Schedule 1.5.
1.6. "CIMA Technical Information" shall mean (a) techniques and
data, including ideas, inventions (including patentable
inventions, but excluding inventions covered by CIMA Licensed
Patents), practices methods, knowledge, know-how, trade
secrets, skill, experience, documents, apparatus, test data,
including pharmacological, toxicological and clinical test
data, analytical and quality control data, manufacturing,
patent data or descriptions relating to Licensed Product,
including, but not limited to, those that relate to
DuraSolv(R)Technology, PakSolv(R)Technology and/or
OraSolv(R)Technology, owned or Controlled by CIMA and/or its
Affiliates and (b) chemical formulations, compositions of
matter, product samples and assays relating to Licensed
Product, including, but not limited to, those that relate to
DuraSolv(R)Technology, PakSolv(R)Technology and/or
OraSolv(R)Technology, owned or Controlled by CIMA and/or its
Affiliates. CIMA Technical Information shall include Developed
Intellectual Property. CIMA Technical Information shall not
include any Work Product.
1.7. "CIMA Licensed Technology" shall mean CIMA Licensed Patents
and CIMA Technical Information.
1.8. "Control or Controlled" in the context of intellectual
property rights shall mean rights sufficient to allow a grant
of such rights to a party, including by license.
1.9. "Developed Intellectual Property" shall mean any and all
intellectual property rights, including but not limited to,
inventions, whether patentable or not, and know-how arising
out of the performance of the Work Plan. Developed
Intellectual Property shall not include any party's
intellectual property existing as of the Effective Date.
1.10. "Development Specifications" shall mean the development goals
for the sensory, physical and functional parameters for the
Licensed Product as set forth in Schedule 1.10.
1.11. "DuraSolv(R)Technology" shall mean the fast-dissolving drug
delivery system generally described in U.S. Patents 6,024,981
and 6,221,392 and PCT Published Application No. WO 98/46215.
1.12. "Exclusive Field" shall mean any product containing
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***].
1.13. "FDA" shall mean the United States Food and Drug
Administration, or any successor thereto.
1.14. "Field" shall mean the treatment of all human conditions.
1.15. "Good Clinical Practice" shall mean the then current standards
for clinical trials for pharmaceuticals, as set forth in the
United States Federal Food, Drug and Cosmetic Act and
applicable regulations promulgated thereunder, as amended from
time to time.
1.16. "Good Laboratory Practice" shall mean the then current
standards for laboratory activities for pharmaceuticals, as
set forth in the United States Federal, Food, Drug and
Cosmetic Act and applicable regulations promulgated
thereunder, as amended from time to time.
1.17. "Good Manufacturing Practice" shall mean the then current
standards for manufacture of pharmaceuticals, as set forth in
the United States Federal, Food, Drug and Cosmetic Act and
applicable regulations promulgated thereunder, as amended from
time to time.
1.18. "Licensed Product" shall mean oral disintegrating tablets
containing [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] and all improvements and line extensions
thereof.
1.19. "Net Sales" shall mean, for the applicable period, the gross
amount invoiced by [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] or its sublicensees for the sale or
other disposition of Licensed Product, less customary
adjustments from gross sales to net sales as determined in
accordance with U. S. Generally Accepted Accounting Principles
as consistently applied by [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***], including but not
limited to: (a) customary quantity, trade and/or cash
discounts, allowances, chargebacks, rebates and price
adjustments or reductions consistently applied by
[***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***]; (b) actual credits,
rebates, or refunds for Licensed Product that are rejected,
returned or destroyed by customers; (c) freight, postage, and
shipping expenses (including insurance relating thereto)
absorbed by [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] or its Affiliates and (d) sales and other
excise taxes and duties directly related to the sale, to the
extent included in the gross invoiced amount. Net Sales shall
not include any sales of Licensed Product to Affiliates and
permitted sublicensees if such Affiliates and permitted
sublicensees are not end-users, but Net Sales shall include
the subsequent final sales to third parties by any such
Affiliates or sublicensees.
1.20. "Oral Disintegrating Tablets" shall mean a solid tablet dosage
form containing medicinal substances which disintegrates
rapidly, usually within a matter of seconds when taken orally.
1.21. "OraSolv(R)Technology" shall mean the fast-dissolving drug
delivery system generally described in U.S. Patent 5,178,878
and U.S. Patent Application 08/468,913.
1.22. "PakSolv(R)Technology" shall mean the packaging system
generally described in U.S. Patents 6,155,423; 6,269,615 and
6,311,462.
1.23. "Pass-Through Costs" shall mean all costs incurred and paid by
CIMA to third parties for services, expenses and equipment
relating solely to CIMA's performance under the Work Plan.
1.24. "Royalty Period" shall mean the period commencing on the
Effective Date and ending with the last-to-expire issued CIMA
Licensed Patent in the country of sale which has at least one
valid claim covering any Licensed Product in the country of
sale and in the Field.
1.25. "Territory" shall mean the entire world.
1.26. "Trademarks" shall mean the trademarks, tradenames (and
registrations and applications therefor) controlled by each of
the parties and used on Licensed Product, including, initially
the applicable CIMA Trademarks listed on Schedule 1.26(a)
hereto and the applicable [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] Trademarks listed on
Schedule 1.26(b) hereto.
1.27. "Work Plan" shall mean the activities to be conducted by the
parties and their agents and Affiliates to develop Licensed
Products using DuraSolv(R)
Technology, PakSolv(R) Technology and/or OraSolv(R)
Technology, including the activities, budget and timeline as
set forth on Schedule 1.27 hereof.
1.28. "Work Product" shall mean any and all results, including
technical data and documentation arising from the performance
of the Work Plan as performed by or for the parties, including
but not limited to the formulation, formulation development,
analytical development, manufacturing process development,
scale up activities, clinical manufacturing, regulatory
services, stability studies, toxicology studies, clinical
trials and other activities outlined in or arising from the
Work Plan. Work Product shall not include any Developed
Intellectual Property.
2. PERFORMANCE OF THE WORK PLAN
2.1. Development Steering Committee; Project Coordinators.
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
shall appoint three (3) members and CIMA shall appoint two (2)
members to a Development Steering Committee ("DSC"). The
objective of the DSC is to coordinate efforts under the this
Agreement and the Work Plan. The DSC shall meet no less
frequently than once per calendar quarter to review the Work
Plan, including but not limited to the budget and timeline.
This meeting may be telephonic upon mutual agreement of the
parties. CIMA and [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] shall each appoint a project
coordinator. CIMA's project coordinator shall provide a
monthly report to [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] project coordinator in sufficient
detail to allow [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] project coordinator to comprehend in all
material respects the status of the Work Plan. The project
coordinators may, but shall not necessarily be, members of the
DSC. In accordance with Section 2.1, the DSC shall be
responsible for reviewing and determining if the measurable
criteria for successful completion of each task for each
License Milestone Fee has been met.
2.2. Budget and Payment. A budget and payment Schedule (a "Budget
and Payment Schedule") for the services to be performed by
CIMA under the Work Plan shall be specifically set forth in
the Work Plan. In consideration for performance of such
services under the Work Plan, CIMA will receive payment for
(i) each completed task and (ii) the purchase of
equipment/instruments needed for the completion of the Work
Plan that
CIMA does not currently own that will be used exclusively in
the Work Plan and manufacture of Licensed Product, each as set
forth and identified in the Work Plan and as specified in the
Budget and Payment Schedule. All Pass-Through Costs shall be
billed at CIMA's actual incurred costs, without xxxx-up. No
expenditure in excess of an individual estimated budgeted item
shall be made unless approved in writing in advance by the
DSC. In the event the DSC removes in whole or in part any
tasks from the Work Plan, [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] shall only be
responsible for the actual expenses incurred by CIMA to the
date the DSC removed such task(s) for the removed items, as
supported by reasonable documentation accompanying any invoice
related thereto. In the event that the DSC adds in whole or in
part any tasks to the Work Plan, [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] shall be responsible
for the agreed DSC budgeted costs therefor. CIMA shall invoice
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] on
a quarterly basis. [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] shall own all equipment itemized in
the Work Plan and purchased with funds provided by
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
hereunder. Following completion of the Work Plan or
termination of the Supply Agreement, as applicable, CIMA shall
deliver such equipment to [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] in such a manner as
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
shall reasonably request at [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] expense.
2.3. Variances in the Work Plan.
2.3.1. The DSC shall have the authority to amend the
Development Specifications with the consent of all
the members of the DSC. Once approved by the DSC,
such written amendments to the Development
Specifications shall constitute an amendment to
Schedule 1.9 hereto.
2.3.2. In the event an amendment to the Development
Specifications or any other request by
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] requires CIMA to perform services
beyond the scope of work set forth in the Work Plan,
CIMA shall, in the case of an amendment to the
Developmental Specifications or if it is willing to
perform the requested services beyond the scope of
work set forth in the Work Plan, proceed as follows:
consistent with the desire of both parties not to
disrupt the ongoing progress of the Work Plan, CIMA
shall use commercially reasonable efforts to (i)
submit a proposed Budget and Payment Schedule for
such out of scope work prior to commencing such work
and (ii) obtain written authorization from
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] to proceed with such work, which
consent shall not be unreasonably withheld. In either
case, both parties agree to use good faith efforts to
negotiate and agree upon a revised Budget and Payment
Schedule as soon as practicable. Any requests to vary
the Work Plan, including changes to the Developmental
Specifications, shall be made in writing and
submitted to the DSC for approval.
2.4. CIMA Performance. CIMA shall use commercially reasonable
efforts to diligently undertake its obligations under the Work
Plan, including but not limited to product development,
manufacturing, preparation of the CMC section of the NDA
filing, and pre-approval Inspection. Further, CIMA agrees:
2.4.1. to conform to all applicable laws and regulations,
including but not limited to current Good Laboratory
Practices, Good Manufacturing Practices and Good
Clinical Practices in effect at the time that the
obligations are performed; and
2.4.2. to provide to [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.***] a complete disclosure of
the Work Product, including all documents reasonably
requested by [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.***], including all of CIMA's
technical data, information and expertise relating to
formulation and manufacture of Licensed Products.
Such disclosure shall be made no less frequently than
quarterly. CIMA shall also execute such documents and
take such steps as [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] may
reasonably request, at [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] expense, in
order to vest [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.***] with full record
ownership of the Work Product.
2.5. [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
Performance. [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] shall use commercially reasonable efforts to
diligently undertake the following activities relating to the
Licensed Product according to the Work Plan: (1)
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***],
(2) providing assistance in developing the product development
strategy, (3) conducting or having a CRO conduct the
bioequivalencey and other clinical studies, (4) filing and
maintaining the NDA with CIMA as the approved manufacturer as
required pursuant to the Manufacturing Agreement in
substantially the form as set forth in Schedule 2.11
("Manufacturing Agreement"), (5) undertaking market
development, launch, and sales and marketing activities in the
Territory, and (6) execute such documents and take such steps
as CIMA may reasonably request, at CIMA's expense, in order to
vest CIMA with full record ownership of the Developed
Intellectual Property. Further, [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] agrees:
2.5.1. to make payments under this Agreement when due and
payable; and
2.5.2. to conform to all applicable laws and regulations,
including but not limited to current Good Laboratory
Practices, Good Manufacturing Practices and Good
Clinical Practices in effect at the time that the
obligations are performed.
2.6. Safety. Each party shall be responsible for the safety of its
own employees and agents with respect to the handling, use, or
storage of materials involved in performance of the Work Plan.
2.7. Regulatory Approvals. [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] shall own all right, title and
interest in and to the regulatory approvals for the Licensed
Products. [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] shall have the right, in its sole and absolute
discretion, to submit any regulatory submissions with respect
to Licensed Product outside of the United States. During the
Royalty Period, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] (i) shall keep CIMA reasonably informed of
material issues affecting regulatory filings concerning
Licensed Product; (ii) shall be responsible for all
communications with the FDA and other governmental or
regulatory authorities in the Territory and (iii) shall be
responsible for all post-regulatory approval regulatory
requirements in the Territory, including pharmacovigilance and
adverse drug experience reporting.
2.8. Subcontractors. In the event that CIMA desires to use the
services of third parties to perform any of its obligations
under this Agreement, CIMA shall first obtain the written
approval, which shall not be unreasonably withheld, of
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
with respect to each such subcontractor and, prior to such
approval and thereafter, shall provide [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] with any information
reasonably requested by [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] or any governmental or regulatory
authority with respect to each such subcontractor. With
respect to each subcontractor approved by [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***], CIMA shall ensure
that each such subcontractor complies with the applicable
obligations of CIMA under this Agreement and shall enter into
a written agreement with each such subcontractor that:
2.8.1. contains obligations of confidentiality on such
subcontractor no less protective of [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
Confidential Information than the obligations of CIMA
under this Agreement (written evidence of such to be
provided to [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] upon
written request);
2.8.2. shall include substantially the same terms as those
appearing in Section 7 Ownership of Intellectual
Property to ensure that [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] obtains the
same rights in the intellectual property generated
under such subcontractor agreement as those set forth
in this Agreement;
2.8.3. permits [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] to exercise its inspection
and audit rights pursuant to Section 7;
2.8.4. permits CIMA to assign the agreement to
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] upon [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] request; and
2.8.5. does not impose any payment obligations and/or
liability on [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.***].
2.9. Storage of Original Records. Records related to or arising out
of the performance of the Work Plan shall be stored by CIMA in
accordance with applicable FDA archival guidelines. At least
ninety (90) days prior to the expiration of the storage period
required by the FDA, CIMA shall notify [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] in writing of such
expiration, and at the end of such period, shall transfer such
records to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] in a manner designated by [***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.***] shall be responsible for the cost of the
transfer of such records.
2.10. Insurance. Each party shall maintain comprehensive general
liability insurance, including blanket contractual liability
insurance covering its obligations under this Agreement while
the Agreement is in effect, which insurance shall afford
limits of not less than five million dollars ($5,000,000.00)
for each occurrence and five million dollars ($5,000,000.00)
in total for bodily injury liability, personal injury
liability, products, liability, property damage liability,
contractual liability and completed operations liability. The
parties shall provide each other with certificates of
insurance evidencing the above and showing the name of the
issuing company, the policy number, the effective date, the
expiration date and the limits of liability. The insurance
certificate shall further provide for a minimum of thirty (30)
days written notice to the other party of a cancellation of or
material change in the insurance. Each party's comprehensive
general liability insurance policy shall contain a waiver of
subrogation rights which the other party's insurer(s) may have
against it.
2.11. Manufacturing Agreement. Concurrently with the execution of
this Agreement the parties shall enter into the Manufacturing
Agreement in substantially the form set forth in Schedule 2.11
hereto.
3. LICENSE GRANT
In consideration of the development and license fees and royalties,
specified in paragraphs 4.1, 4.2 and 4.3, CIMA grants to
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] the following rights
during the term of this Agreement:
3.1. Grant of License. CIMA hereby grants to [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] an exclusive license,
even as to CIMA subject to Sections 3.2, 3.4 and 7 below, with
the right to grant sublicenses, under the CIMA Licensed
Technology to use, make, have made, develop, have developed,
offer to sell, sell, have sold, distribute, import or
otherwise dispose of Licensed Products in the Field in the
Territory.
3.2. Manufacturing. [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] rights to make or have made Licensed Products
shall be restricted pursuant to the terms of the Manufacturing
Agreement.
3.3. Non-Compete. From the Effective Date and until the later of:
a) ten (10) years from the date of the first commercial sale
by [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] or
its sublicensees of the first Licensed Product under this
Agreement, and b) the end of the Royalty Period, CIMA and its
Affiliates shall not, directly or indirectly, or assist a
third party to, compete with or develop a product, which
product contains [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***].
3.4. Right to Sublicense. [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] shall be entitled to grant
sublicenses under the license granted in Section 3.1 (a) to
any third party for consideration and in an arm's-length
transaction, or (b) to an Affiliate of [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***], provided that (i)
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
shall promptly notify CIMA upon the execution of any such
third-party sublicense, including such sublicensee's name,
(ii) the terms and conditions of such grant of sublicense
rights (x) are consistent with and do not violate the terms
and conditions of this Agreement, and (y) provide
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
with the right and obligation to enforce such terms and
conditions; and (iii) [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] remains primarily liable and
responsible for the performance of any such sublicensee
according to the terms of this Agreement. Notwithstanding the
foregoing, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] shall not grant a sublicense to a CIMA
Competitor.
4. PAYMENTS
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] shall make payments to
CIMA, in United States dollars by wire transfer of immediately
available funds, as follows:
4.1. Development Fees. [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] shall pay CIMA for the work invoiced
by CIMA upon completion of the tasks identified in the Work
Plan. CIMA shall provide [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] a reasonably detailed invoice for
completed services on a quarterly basis in writing. Invoices
shall describe the services performed and shall be accompanied
by supporting documentation. All Pass-Through Costs must be
itemized and supported by third-party invoices.
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
will pay such invoices within [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] following receipt
thereof.
4.2. License Milestone Fee(s).
4.2.1. A license milestone fee ("License Milestone Fee")
shall be payable by [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] within
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] of completion of the following
milestones: [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.***]
4.2.2. Under no circumstances shall CIMA be entitled to more
than one of each License Milestone Fee, unless the
scope of this Agreement is expanded and this
Agreement is amended to reflect such expanded scope.
4.3. Royalties.
4.3.1. Royalty Amount: In consideration for the grant of the
license set forth in Section 3.1 above, during the
Royalty Period, [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.***] shall pay to CIMA a
royalty on combined Net Sales of Licensed Product as
follows:
Annual Net Sales Royalty Rate
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
For example, if annual Net Sales of Licensed Products in a given year
are [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***].
4.3.2. Royalties shall be payable on a quarterly basis,
within [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] after the end of each
calendar quarter, based upon the Net Sales during
each calendar quarter, commencing with the calendar
quarter in which the first commercial sale of such
Licensed Product is made.
4.3.3. [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] shall furnish to CIMA a non-binding
royalty estimate, with in ten (10) calendar days
after the close of the quarter.
4.3.4. [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] shall furnish to CIMA at the same
time as each royalty payment is made, a written
report showing (i) the gross sales of Licensed
Product by [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.***] and its Affiliates and
permitted sublicensees during the reporting period
and the calculation of the Net Sales from such gross
sales, (ii) the calculation of the royalty due and
payable for the calendar quarter upon which the
royalty payment is based; (iii) the launch date(s) of
Licensed Products in any country(ies) during the
reporting period; and (iv) the exchange rates used in
determining the amount of payment hereunder.
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] shall not be required to provide a
reconciliation between the royalty payments and the
non-binding estimate provided in Section 4.3.3 above.
4.3.5. [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] shall keep, or cause to be kept,
full, complete and proper records and accounts of Net
Sales of Licensed Product in sufficient detail to
enable the royalties payable hereunder to be
determined. CIMA shall have the right at its own
expense to appoint an independent certified public
accounting firm to audit the records which are
necessary to verify the royalties payable pursuant to
this Agreement; provided, however, that if the audit
discloses that CIMA was underpaid royalties by at
least [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] for any calendar year, then
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] shall reimburse to CIMA any
documented and reasonable costs of such audit and
CIMA shall refund to [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] an amount
equal to any overpayment of royalties as disclosed by
the audit. In any event, [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] shall pay to
CIMA an amount equal to the additional royalties to
which CIMA is entitled as disclosed by the audit.
CIMA may exercise its right of audit no more
frequently than once in any calendar year. The
accounting firm shall disclose to CIMA only
information relating solely to the accuracy of the
royalty payments and reports. [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
shall preserve and maintain all such records required
for audit for a period of three (3) years after the
calendar quarter to which the record applies.
5. TERM AND TERMINATION
5.1. Term. This Agreement shall commence on the Effective Date and
shall remain in full force and effect until agreed to in
writing or terminated pursuant to this Agreement.
5.2. Termination. This Agreement may be terminated as follows:
5.2.1. By mutual agreement of the parties;
5.2.2. By [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***]:
5.2.2.1. without cause, provided that CIMA is given
thirty (30) days advance written notice of
termination;
5.2.2.2. if CIMA is in material breach of this
Agreement and fails to cure such breach
within sixty (60) days after receipt of
written notice from [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] identifying the breach; or
5.2.2.3. if CIMA enters into bankruptcy, whether
voluntary or involuntary, has a receiver
appointed, becomes insolvent, enters into
any arrangement with its creditors, takes or
suffers any similar action in consequence of
debt, or ceases or threatens to cease to
carry on its business as usual.
5.2.3. By CIMA:
5.2.3.1. if [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] is
in material breach of this Agreement and
fails to cure such breach within sixty (60)
days (or in the event or case of a
non-disputed payment due, thirty (30) days)
after receipt of written notice from CIMA
identifying the breach;
5.2.3.2. a) if [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] does
not submit the initial orders for Licensed
Product within six (6) months of the FDA NDA
approval for the first Licensed Product as
set forth in Section 4.2.1.5; b) if the
first commercial sale by [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] or its sublicensees of the
first approved Licensed Product by the FDA
does not occur within six (6) months after
receipt of commercial supply (including
samples) of Licensed Product in conformity
with orders placed by [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] with CIMA under the terms of
the Manufacturing Agreement as set forth in
Schedule 2.11 due to causes other than force
majeure or an
act or omission on the part of CIMA or its
subcontractors or Affiliates; or c) if
[***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***]
permanently discontinues the sale of all
Licensed Products ("permanently" for
purposes of this subsection shall be deemed
to be for a period of twelve (12)
consecutive months or more, other than by
reason a breach of this Agreement or the
Supply Agreement by CIMA, force majeure or
the reorganization in bankruptcy of
[***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***]);
for purposes of determining if c) above is
in effect, CIMA may send a written request
to [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] at
any time requesting verification
[***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] most
recent sale or promotion of the Licensed
Products and [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] shall respond to CIMA within
fifteen (15) business days following CIMA's
written request; or
5.2.3.3. [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***]
enters into bankruptcy, whether voluntary or
involuntary, has a receiver appointed,
becomes insolvent, enters into any
arrangement with its creditors, takes or
suffers any similar action in consequence of
debt, or ceases or threatens to cease to
carry on its business as usual.
5.3. Effect of Termination. Upon termination of this Agreement, the
parties shall have the following rights and obligations:
5.3.1. If terminated by both parties pursuant to paragraphs
5.2.1 or by [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.***] pursuant to paragraph
0.0.0.0:
(a) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] shall be obligated to pay
any earned but unpaid amount, as provided for under
the Work Plan pursuant to Section 4.1 and License
Milestones pursuant to Section 4.2, and any costs and
expenses reasonably incurred by CIMA in anticipation
of performance of its obligations under this
Agreement and not otherwise covered by payments under
Section 4.1; provided, however, that CIMA shall
immediately cease activities on the Work Plan and
take all reasonable steps to minimize such costs and
expenses referred to above; (b) [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
shall retain all right, title and interest in the
Work Product, regardless of the status of the Work
Plan and CIMA shall retain all right, title and
interest in the Developed Intellectual Property in
accordance with Section 7.4.3; (c) CIMA shall provide
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] with a complete disclosure of all
Work Product not yet disclosed to [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***]; (d)
the provisions of Sections 3.2 and 3.3 shall
terminate; and (e) the license granted in Section 3.1
shall immediately terminate with any license grant
reverting back to CIMA.
5.3.2. If terminated by [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] pursuant to
paragraph 0.0.0.0: (a) [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] shall not be
obligated to pay any non-invoiced unpaid deliverable
payment, provided that CIMA's material breach for
which this Agreement is being terminated by
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] is not directly related to
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] failure to make payments due to CIMA,
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] in accordance with this Agreement
or provide accurate records of sales of Licensed
Products, as provided for under the Work Plan
pursuant to Section 4.1 or License Milestones
pursuant to Section 4.2; (b) [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
shall retain all right, title and interest in the
Work Product, regardless of the status of Work Plan
and CIMA shall retain all right, title and interest
in the Developed Intellectual Property in accordance
with Section 7.4.3; (c) CIMA shall provide
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] with a complete disclosure of all
Work Product not yet disclosed to [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] in
the manner set forth in paragraph 2.4.2; (d) the
provisions of Sections 3.2 and 3.3 shall survive; (e)
all rights granted to CIMA pursuant to Section 7.4.2
shall immediately terminate and (f) the license
granted in Section 3.1 and [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] rights to pay
royalties pursuant to Section 4.3 shall survive.
5.3.3. If terminated by [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] pursuant to
paragraph 0.0.0.0: (a) [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] shall be
obligated to pay any earned but unpaid amount, as
provided for under the Work Plan pursuant to Section
4.1 and License Milestones pursuant to Section 4.2,
and any costs and expenses reasonably incurred by
CIMA in anticipation of performance of its
obligations under this Agreement and not otherwise
covered by payments under Section 4.1; provided,
however, that CIMA shall immediately cease activities
on the Work Plan and take all reasonable steps to
minimize such costs and expenses referred to above;
(b) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] shall retain all right,
title and interest in the Work Product, regardless of
the status of Work Plan and CIMA shall retain all
right, title and interest in the Developed
Intellectual Property in accordance with Section
7.4.3; (c) CIMA shall provide [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] with a
complete disclosure of all Work Product not yet
disclosed to [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.***] in the manner set forth
in paragraph 2.4.2; (d) the provisions of Sections
3.2 and 3.3 shall survive and (e) the license granted
in Section 3.1 and [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] rights to pay
royalties pursuant to Section 4.3 shall survive.
5.3.4. If terminated by CIMA pursuant to paragraph 5.2.3.1
or 0.0.0.0: (a) [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.***] shall be obligated to
pay any unpaid amount, and costs and expenses as
provided for in Section 5.3.1(a); (b)
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] shall retain all right, title and
interest in the Work Product, regardless of the
status of Work Plan and CIMA shall retain all right,
title and interest in the Developed Intellectual
Property in accordance with Section 7.4.3; (c) CIMA
shall provide [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.***] with a complete
disclosure of all Work Product not yet disclosed to
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] in the manner set forth in paragraph
2.4.2; and (d) the provisions of Section 3
immediately terminate.
5.3.5. If terminated by CIMA pursuant to paragraph 0.0.0.0:
(a) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] shall be obligated to pay
any unpaid amount, and costs and expenses as provided
for in Section 5.3.1(a); (b) [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
shall retain all right, title and interest in the
Work Product, regardless of the status of Work Plan
and CIMA shall retain all right, title and interest
in the Developed Intellectual Property in accordance
with Section 7.4.3; (c) CIMA shall provide
[***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] with
a complete disclosure of all Work Product not yet
disclosed to [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.***] in the manner set forth
in paragraph 2.4.2; (d) the provisions of Sections
3.2 and 3.3 shall survive and (e) the license granted
in Section 3.1 and [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] obligations
to pay royalties pursuant to Section 4.3 shall
survive.
5.4. Survival. Except as may be modified pursuant to Section 5.3,
the rights and obligations set forth in Sections 2.4.2,
2.5(6), 3.4, 5, 7, 8, 9, 10, 13 and 14 shall survive the
termination of this Agreement for any reason. If the Agreement
is terminated by [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] pursuant to paragraph 5.2.2 or by CIMA
pursuant to paragraph 5.2.3, such termination shall not
extinguish any claim that either may have against the other
party for damages, injunction or other remedies arising out of
a breach or nonperformance.
6. INSPECTIONS AND AUDITS
6.1. [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
and its authorized representatives shall have the right to
inspect the manufacturing and testing facilities of CIMA and
its subcontractors or agents, and to discuss and review in
reasonable detail the process and quality control procedures
used (and the records created) by CIMA during the term of this
Agreement with any employees or consultants familiar with the
Work Plan; provided, however, that such inspections shall be
during normal business hours and shall not unreasonably
interrupt the operations of CIMA, and cannot infringe the
confidentiality of other CIMA partners or agreements. Such
inspections shall be made no more frequently than once each
calendar year unless consented to by CIMA in writing, such
consent not to be unreasonably withheld.
6.2. [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
and its authorized representatives shall have the right to
audit the financial records of CIMA using an independent
certified public accountant, at [***CONFIDENTIAL TREATMENT
REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] cost and discretion, during CIMA's
normal business hours during the terms of this Agreement to
verify CIMA's charges billed to the Work Plan pursuant to the
terms of Section 2 hereof. This audit right shall be exercised
no more than once during any calendar year. If the audit
discloses that [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] was overcharged by at least [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] for any calendar year,
then CIMA shall reimburse to [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] any documented and
reasonable costs of such audit and CIMA shall refund to
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] an
amount equal to any overcharge as disclosed by the audit. In
any event, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] shall pay to CIMA an amount equal to any
undercharge to which CIMA is entitled as disclosed by the
audit.
6.3. CIMA shall cooperate with the FDA or any other governmental
agency with respect to any inspections it may require of
CIMA's facilities and procedures as a result of the Work Plan.
CIMA shall promptly notify in writing and provide copies to
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of
any communications CIMA may send or receive to or from the FDA
or any other governmental agency if such communications relate
in any way to the Work Plan or Licensed Product.
[***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 CIMA shall give
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] 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 manufacturing activities.
7. OWNERSHIP OF INTELLECTUAL PROPERTY
7.1. CIMA Licensed Technology. CIMA Licensed Technology is and
shall remain the sole property of CIMA.
7.2. Ownership of Products. [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] shall solely own any and all Licensed
Products developed under this Agreement.
7.3. Ownership of Regulatory Filings. [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] shall file, own and
control all regulatory fillings, including but not limited to
filings with the FDA.
7.4. Ownership of Work Product and Developed Intellectual Property.
7.4.1. Each party shall retain ownership to its existing
intellectual property and intellectual property
developed outside of the Work Plan. CIMA shall have a
license to use any intellectual property Controlled
by [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] solely for the purpose of
performing its obligations under this Agreement.
7.4.2. Any and all Work Product, whether or not jointly
developed, including but not limited to data and
reports generated by CIMA and/or CIMA's agents, shall
be the sole and exclusive property of
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***]; provided, however, CIMA shall have
an exclusive worldwide, fully-paid, royalty-free
license to use Work Product in support of obtaining
patent protection with respect to the Developed
Intellectual Property.
7.4.3. Any and all Developed Intellectual Property shall be
owned by CIMA and shall be considered part of CIMA
Licensed Technology, subject to the rights granted to
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] hereunder and subject to a mutually
agreed upon license for the Developed Intellectual
Property that utilized [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] proprietary
technology.
7.5. Ownership and Use of Trademarks.
7.5.1. Each party shall own and control their own Trademarks
and the goodwill associated therewith and shall be
solely responsible for prosecuting and maintaining
any trademarks, trademark applications and/or
trademark registrations. CIMA shall not use any
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] Trademark.
7.5.2. Neither party may use the other party's name except
as required by law or regulation or as agreed to in
writing by the parties; provided, however,
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] shall include the applicable CIMA
Trademarks identified in Schedule 1.26(a) (the "CIMA
Trademarks") and the applicable CIMA Licensed Patent
markings on the packaging of Licensed Product and, at
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] sole discretion, in marketing and
promotional materials.
7.5.2.1. [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] will
use CIMA Trademarks in labeling of License
Product as requested in writing by CIMA, in
a frequency, size, format and location as
reasonably requested by CIMA and as
reasonably agreed to by [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***], prior to the required time
for [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***]
submissions of artwork as set forth in the
Manufacturing Agreement in substantially the
form of Schedule 2.11 hereto.
7.5.2.2. [***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 of Licensed
Product in the Territory in accordance with
Section 7.5.2; provided, however that the
particular formulation of any reference to
CIMA's name and CIMA Trademarks 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 and CIMA's
Trademarks using such formulation shall not
be subject to the further review or consent
of CIMA.
7.5.3. For the purpose of this Section 7.5, CIMA grants to
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] and its permitted sublicensees and
Affiliates a non-exclusive license to the CIMA
Trademarks identified in Schedule 1.26(a) during the
term of this Agreement for the purpose of performing
its obligations under this Agreement. Following the
Effective Date, CIMA shall provide to
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] its policies and procedures with
respect to third party use of its trademarks, and
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] shall use commercially reasonable
efforts to conform to such procedures.
7.6. Protection of Intellectual Property. At CIMA's sole discretion
and expense, CIMA may file for worldwide patent protection for
any Licensed Products that embodies Developed Intellectual
Property. CIMA shall have full control over the prosecution
and maintenance of any such patent applications filed that
claim inventions that embodies CIMA License Technology and
Developed Intellectual Property that does not utilize any
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
proprietary technology. [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] and its Affiliates shall cooperate
with CIMA, at CIMA's expense, in any such applications filed
by CIMA anywhere in the world. [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] shall have the right
to comment on any correspondence or filing relating to
Licensed Product and to review and approve any proposed
response(s) prior to their submission. CIMA shall provide a
reasonable amount of time for [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] to
review and comment on such correspondence, filings and
response(s) and shall reasonably act upon any reasonable
comments made by [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] concerning the file or prosecution of such
applications. If CIMA desires to allow any application or
patent claiming Licensed Product to lapse, [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] shall have the right
to control such application or patent at [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] expense.
7.7. Notice of Actual or Threatened Infringement or Third Party
Claims.
7.7.1. Each party shall give notice to the other party
promptly, completely and in writing of any known or
suspected infringement or threatened infringement of
any CIMA Licensed Patents in the Exclusive Field
("Infringement"), and any claim that a CIMA Licensed
Patent is invalid. CIMA shall enforce and defend the
CIMA Licensed Patent, including, without limitation,
prosecute any Infringement and to defend against any
claim that the CIMA Licensed Patent is invalid, at
its own expense. CIMA shall commence, maintain and
direct such enforcement or defense as promptly as is
reasonably necessary, but in no event later than
ninety (90) days after the receipt of the notice of
the Infringement or claim of invalidity.
7.7.2. Any damages or settlement recovered in connection
with such enforcement or defense by CIMA shall be
retained solely by the CIMA.
7.7.3. [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] shall reasonably cooperate with and
assist CIMA in such enforcement or defense. CIMA
shall reimburse [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.***] its reasonable expenses
(excluding attorneys' fees) in providing such
cooperation and assistance and will hold
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] harmless from all liability and all
costs or
expenses associated with or arising out of its
truthful and good faith actions in providing such
cooperation and assistance.
7.7.4. CIMA shall keep [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.***] reasonably informed
regarding the status of actions taken by or on behalf
of CIMA pursuant to this Section 7.7, including
prompt notice of CIMA's commencement of enforcement
or defense and its determination that it will not
undertake or has completed such enforcement or
defense.
7.7.5. In the event either party gives notice of
Infringement or a claim of invalidity and CIMA has
not commenced enforcement or defense within ninety
(90) days of receipt of such notice, [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] may,
in its sole discretion, commence, maintain and direct
such enforcement or defense, at its own expense. CIMA
shall join any action initiated by [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***] as a
party if [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.***] so requests.
7.7.6. [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***]
7.7.7. CIMA shall reasonably cooperate with and assist
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] in such enforcement or defense.
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] shall reimburse CIMA's reasonable
expenses (excluding attorneys' fees) in providing
such cooperation and assistance and will hold CIMA
harmless from all liability and all costs or expenses
associated with or arising out of the truthful and
good faith actions of CIMA in providing such
cooperation and assistance.
7.7.8. [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] shall keep CIMA reasonably informed
regarding the status of actions taken by or on behalf
of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] pursuant to this Section
7.7, including prompt notice of its commencement of
enforcement or defense and its determination that it
will not undertake or has completed such enforcement
or defense.
7.7.9. Any settlement of any action for Infringement or
defense of any claim that the CIMA Licensed Patent is
invalid must be approved in writing by both parties.
Such approval may not be unreasonably withheld,
delayed or conditioned.
7.7.10. Any settlement shall be consistent with the terms of
this Agreement.
7.7.11. Each party shall give notice to the other party
promptly, completely and in writing of any claim of
infringement or threatened infringement of third
party intellectual property rights by use of the CIMA
Licensed Technology in accordance with this Agreement
or any related agreements ("Third Party
Infringement"). Except as provided pursuant to
Section 8 hereof, should an action be brought against
either party regarding such Third Party Infringement,
the other party shall reasonably cooperate with and
assist in such defense of use of the CIMA Licensed
Technology. Except as provided pursuant to Section 8
hereof, each party shall keep the other reasonably
informed regarding the status of actions taken
pursuant to this Section 7.11, including prompt
notice of its commencement of defense and its
determination that it will not undertake or has
completed such defense.
7.7.12. Except as provided pursuant to Section 8 hereof, CIMA
shall join any Third Party Infringement action as a
party, if [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.***] so requests.
7.7.13. Except as provided pursuant to Section 8 hereof, any
settlement of any action for Third Party Infringement
must be approved in writing by both parties. Such
approval may not be unreasonably withheld, delayed or
conditioned.
8. INDEMNIFICATION
8.1. Indemnification by [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***]. Subject to the terms of Section 8.3,
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
shall indemnify, defend and hold CIMA, its Affiliates and
their respective directors, officers, shareholders, employees,
representatives, agents, successors and permitted assigns
("CIMA Indemnified Parties") harmless from and against any and
all third party liabilities, losses, claims, demands,
obligations, judgments, causes of action, assessments, fines,
damages, costs and expenses (including, without limitation,
reasonable attorneys' fees) (collectively, "Claims"), in each
case to the extent such Claims arise out of: (a) a breach or
inaccuracy of any representation or warranty made by
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] in
Section 11 or 12.2 of this Agreement; (b) a material breach of
this Agreement by [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***]; (c) any negligence or willful or
reckless actions or misconduct of [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] or its employees,
agents and/or subcontractors; (d) [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***]; (e) any allegation of
infringement or misappropriation of copyright or trademark
rights of any party resulting from [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] instructions for
labeling or packaging of Licensed Products; and (f) the
manufacture, promotion, distribution, use, testing, marketing
and sale of Licensed Products by [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***], its Affiliates or
sublicensees. Notwithstanding the foregoing, [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] shall not be liable
for any Claims to the extent caused by any of the CIMA
Indemnified Parties as determined in a final, non-appealable
order of a court of competent jurisdiction.
8.2. Indemnification by CIMA. Subject to the terms of Section 8.3,
CIMA shall indemnify, defend and hold [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***], its Affiliates and
their respective directors, officers, shareholders, employees,
representatives, agents, successors and permitted assigns
("[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
Indemnified Parties") harmless from and against any and all
Claims, in each case to the extent such Claims arise out of:
(a) a breach or inaccuracy of any representation or warranty
made by CIMA in Sections 11 and 12.1 of this Agreement; (b) a
material breach of this Agreement by CIMA; (c) any negligence
or willful or reckless actions or misconduct of CIMA or its
Affiliates, employees, agents and/or subcontractors; (d) the
manufacture, use, testing, disposal or development of Licensed
Product by CIMA, its Affiliates or subcontractors; and (e)
third party claims against [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] for alleged
infringement of such party's trademark rights due to
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
use of CIMA Trademarks in the United States. [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] agrees to give CIMA
prompt notice of any claim by a third party for which
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] is
seeking indemnification under section (e) herein.
Notwithstanding the foregoing, CIMA shall not be liable for
any Claims to the extent caused by any of the [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] Indemnified Parties as
determined in a final, non-appealable order of a court of
competent jurisdiction.
8.3. Procedures for Indemnification.
8.3.1. General. Promptly after becoming aware of same, the
party seeking indemnification (the "Indemnified
Party") shall notify the other party (the
"Indemnifying Party") of any Claims covered under the
terms of Sections 8.1 or 8.2, as applicable, for
which the Indemnified Party seeks indemnification;
provided, however, that any delay in giving such
notice shall not relieve the Indemnifying Party
hereunder except to the extent such delay materially
prejudices the Indemnifying Party's ability to defend
against such Claim or materially increases the amount
of damages awarded or paid in settlement of such
Claim. For a period that shall not exceed ten (10)
business days following any such notification, the
Indemnified Party and Indemnifying Party shall
investigate and discuss in good faith whether such
claim is subject to indemnification under Sections
8.1 or 8.2, as applicable. During such discussions,
the Indemnified Party shall give the Indemnifying
Party full access to all records, data and personnel
of the Indemnified Party as may be reasonably
necessary to make such determination. If the parties
are unable to agree on whether the Indemnifying Party
is required to indemnify the Indemnified Party under
the terms of Sections 8.1 or 8.2, as applicable, the
Indemnifying Party, at its option, shall either
assume or decline defense of the Claims, including
negotiations for its settlement or compromise.
8.3.2. Defense Assumed. If the Indemnifying Party assumes
defense of a Claim as described herein, the
Indemnified Party shall reasonably cooperate with the
Indemnifying Party in the defense of such Claim and
may be represented, at the Indemnified Party's
expense, by counsel of its choice, provided that,
where the Indemnifying Party has assumed defense of a
Claim, the Indemnifying Party shall have sole control
over such defense. The Indemnifying Party shall not
be responsible for defending any claims other than
those described in Sections 8.1 or 8.2, as
applicable, even if brought in the same suit. In
addition to the foregoing, if a court of competent
jurisdiction later determines that a Claim for which
the Indemnifying Party assumed defense was not
eligible for indemnification under Sections 8.1 or
8.2, as applicable, within thirty (30) calendar days
following such determination, the Indemnified Party
shall reimburse the Indemnifying Party in full for
all judgments, costs and expenses (including without
limitation reasonable attorneys' fees) incurred in
connection with such Claim.
8.3.3. Defense Declined. If the Indemnifying Party declines
to assume defense of any Claim, and it is later
determined by a court of competent jurisdiction that
such Claim was eligible for indemnification under
Sections 8.1 or 8.2, as applicable, with thirty (30)
calendar days following such determination, the
Indemnifying Party shall reimburse the Indemnified
Party in full for all judgments, costs and expenses
(including without limitation reasonable attorneys'
fees) incurred in connection with such Claim.
8.3.4. Settlement of Claims. The Indemnifying Party shall
not settle any Claim without the prior written
consent of the Indemnified Parties if such
settlement: (a) materially diminishes any of the
Indemnified Party's rights under this Agreement or
seeks to impose additional obligations on the
Indemnified Party; or (b) arises out of or is a part
of any criminal action, suit or proceeding or
contains a stipulation or admission or
acknowledgement of any liability or wrongdoing
(whether in contract, tort or otherwise) on the part
of the Indemnified Party.
8.3.5. Contributory Negligence; Right of Contribution.
Nothing contained herein shall bar a claim for
contributory negligence or a party's right of
contribution.
9. CONFIDENTIAL INFORMATION
9.1. [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
Confidential Information. CIMA acknowledges and agrees (a)
that (i) Work Product, (ii) any plans, specifications,
designs, data, results, information, works in progress and any
other documents or material related to the Work Plan, and
(iii) any information, works in progress, trade secrets, data
or other secret, sensitive or confidential material related to
the business technology, products, systems, formulas,
practices, processes, customers or projects of
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
that are disclosed to or become known by CIMA during the term
of this Agreement and which are not generally known to the
public constitute the confidential information of
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
(collectively the "[***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] Confidential Information"); (b) to
hold such [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] Confidential Information in strict confidence
and disclose such [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] Confidential Information only to such
Affiliates, officers and employees as are necessary to carry
out the provisions of this Agreement and who are likewise
bound by provisions equivalent to this Section 9.1; (c) not to
disclose such [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] Confidential Information to any third party;
(d) to use such [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] Confidential Information only as necessary to
perform the services related to the Work Plan; and (e) upon
termination of this Agreement, to destroy or return all
tangible
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
Confidential Information (including tangible media containing
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
Confidential Information) to [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***]. This provision shall
supersede and replace any previous confidentiality and/or
non-disclosure agreements between the parties.
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
Confidential Information shall not include those portions of
Work Product to the extent such portions of Work Product
embody any trade secret within the Developed Intellectual
Property for which [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] has received prior written notice and
reasonable identification thereof from CIMA.
9.2. CIMA Confidential Information. [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] acknowledges and
agrees (a) that any information, work in progress, trade
secrets, data or other secret, sensitive or confidential
material related to the business technology, products,
systems, formulas, practices, processes, customers or projects
of CIMA that are disclosed to or become known by
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
during the term of this Agreement and which are not generally
known to the public constitute the confidential information of
CIMA (collectively the "CIMA Confidential Information") (b) to
hold such CIMA Confidential Information in strict confidence
and disclose such CIMA Confidential Information only to such
Affiliates, officers and employees as are necessary to carry
out the provisions of this Agreement and who are likewise
bound by provisions equivalent to this Section 9.2; (c) not to
disclose such CIMA Confidential Information to any third
party; (d) to use such CIMA Confidential Information only as
reasonably useful to further develop, manufacture, and/or
commercialize any Licensed Product or any formulation based on
Licensed Product and (e) upon termination of this Agreement,
to destroy or return all tangible CIMA Confidential
Information (including tangible media containing CIMA
Confidential Information) to CIMA. This provision shall
supersede and replace any previous confidentiality and/or
non-disclosure agreements between the parties.
9.3. Notwithstanding the provisions of Sections 9.1 and 9.2, the
aforesaid secrecy obligations shall not apply to any
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
Confidential Information or CIMA Confidential Information that
is reasonably demonstrated by the receiving party to fall
within any of the following categories
9.3.1. information that is in the public domain at the time
of disclosure by the disclosing party, or that which
subsequently enters the public domain through no
breach of this Agreement;
9.3.2. information that is demonstrated by written records
to be in the possession of the receiving party prior
to disclosure hereunder;
9.3.3. information obtained by the receiving party from a
third party who is not under a restriction to
disclose such information;
9.3.4. information which is required by law or court order
to be disclosed, or;
9.3.5. information that is independently developed by the
receiving party after disclosure hereunder, without
the aid, application or use in any way of
Confidential Information received under this
Agreement.
Specific [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] Confidential Information or CIMA Confidential
Information shall not be deemed to be available to the public
or in the prior possession of the receiving party merely
because it is embodied in more general information available
to the public or in the receiving party's prior possession.
Any combination of known information shall be within any of
the foregoing exclusions only if the combination as such is
within such exclusion. Any information shown to fall within
the foregoing exceptions shall not be identified by the
receiving party as information, which was received from, is
used by, or considered proprietary by the disclosing party.
9.4. Notwithstanding Sections 9.1, 9.2 and 9.3.4, in the event that
the receiving party becomes legally compelled to disclose any
of the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] Confidential Information or CIMA Confidential
Information, as the case may be, the receiving party will give
the disclosing party prompt notice so that the disclosing
party may seek a protective order or other appropriate remedy.
The receiving party shall furnish only that portion of the
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] Confidential Information or CIMA
Confidential Information, as the case may be that is legally
required to be disclosed.
9.5. Notwithstanding Section 9.2, [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] may disclose any CIMA
Confidential Information, including without limitation any
plans, specifications, designs, processes, reports, papers,
formulas and any other information and material provided to
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
under this Agreement to third parties as reasonably useful to
further develop, enhance, improve, manufacture, or
commercialize any Licensed Products; provided, however, that
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
require any such third parties to execute a corresponding
confidentiality agreement. Under no circumstances may
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
disclose any CIMA Confidential Information to a CIMA
Competitor.
10. DISPUTE RESOLUTION
10.1. The parties, through their designated project coordinators and
the DSC, shall make a good faith effort to resolve any claims,
disputes, or controversies arising out of or relating to this
Agreement or the breach or alleged breach thereof.
10.2. In the event the parties do not or are unable to reach a
mutually agreeable resolution within ten (10) business days of
receipt of written notice of any claim, dispute, or
controversy, the DSC shall promptly elevate the dispute to
representative senior executives of each party in writing.
These senior executives from each party shall within twenty
(20) days thereafter meet for face-to-face negotiations. If
the senior executives are unable to reach a resolution within
ten 10) days after such meeting, the parties may agree in
writing to submit to voluntary, non-binding mediation. Said
mediation shall occur in Wilmington, Delaware within thirty
(30) business days after agreement to submit said dispute to
mediation and shall last for no more than two (2) business
days. In the event the parties do not agree on mediation,
either party may seek such other relief as may be available to
it in law or equity.
10.3. Notwithstanding the foregoing, either party may apply to any
court having jurisdiction over the parties and the subject
matter of the dispute for a temporary restraining order and/or
preliminary injunction to enjoin the other party from
misappropriating or infringing any intellectual property
rights of the moving party, or to enforce the termination or
confidentiality provisions of this Agreement.
11. MUTUAL REPRESENTATIONS, WARRANTIES AND COVENANTS
Each of the parties represents, warrants and covenants to the other
that:
11.1. It has not been debarred and is not subject to debarment and
will not use in any capacity, in connection with the services
to be performed under this Agreement, any person who has been
debarred pursuant to Section 306 of the FDCA, 21 U.S.C. 335a,
or who is the subject of a conviction described in such
Section or who undergoes any analogous proceeding under
foreign law.
11.2. It is validly existing and in good standing under the laws of
the state of its incorporation;
11.3. The execution of this Agreement and full and timely
performance of the covenants, duties and obligations described
herein have been duly authorized by all necessary corporate
action in accordance with all applicable laws.
11.4. It has the full power and authority to execute and deliver
this Agreement and perform its covenants, duties and
obligations described in this Agreement.
11.5. This Agreement is a valid, legal and binding obligation upon
such party, enforceable in accordance with its terms, except
as enforceability may be limited by applicable insolvency and
other laws affecting creditors' rights generally or by the
availability of equitable remedies.
11.6. Each party and their respective agents shall maintain all
records and reports as required to comply with appropriate
work regulations, to obtain FDA approval, and as further
required under the Work Plan.
12. INDIVIDUAL REPRESENTATIONS, WARRANTIES AND COVENANTS
12.1. CIMA represents, warrants and covenants to [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] as follows:
12.1.1. All studies performed by CIMA or its agents and all
materials supplied by CIMA or its agents under the
Work Plan shall conform to, and shall be performed or
manufactured in conformity with
current Good Manufacturing Practices, Good Clinical
Practices and all other applicable FDA regulations;
when shipped from CIMA, materials developed under the
Work Plan shall not be adulterated or misbranded
under the Federal Food, Drug, and Cosmetic Act (the
"FDCA"), or under any other applicable laws,
standards, rules, regulations, or requirements and
may be introduced into interstate commerce pursuant
to the FDCA.
12.1.2. All Licensed Product shall conform to the
specifications set forth in the Work Plan and in any
applicable regulatory filings.
12.1.3. All materials delivered by CIMA under the Work Plan,
including but not limited to Work Product, shall be
free and clear of all liens, security interests, or
other encumbrances.
12.1.4. CIMA shall make prompt payment to all of its
subcontractors under this Agreement.
12.1.5. CIMA owns or Controls the CIMA Licensed Technology
and the CIMA Trademarks and has the right to grant
the licenses granted pursuant to this Agreement.
12.1.6. CIMA has the right to use the CIMA Licensed
Technology in connection with the Work Plan.
12.1.7. CIMA has granted no license and entered into no
agreements that are inconsistent with or will impair
its ability to perform its obligations under this
Agreement, nor will it do so during the term of this
Agreement.
12.1.8. The Licensed Products will not infringe any patents,
trade secrets or other intellectual property rights
of third parties that are known to CIMA. The CIMA
Trademarks will not infringe any intellectual
property rights of third parties that are known to
CIMA.
12.1.9. To its knowledge, the rights that make up the CIMA
Licensed Technology are valid and enforceable.
12.1.10. CIMA has maintained the CIMA Licensed Technology in
full force and effect, including the payment of
maintenance fees and the protection of the
confidential status of all trade secrets and
confidential information. CIMA will continue to do so
during the term of this Agreement.
12.1.11. As of the Effective Date, CIMA has completely and
accurately responded to all due diligence requests
made by
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] with respect to the transactions
contemplated by this Agreement.
12.2. [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
represents, warrants and covenants to CIMA that
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
has granted no license and entered into no agreements that are
inconsistent with or will impair its ability to perform its
obligations under this Agreement, nor will it do so during the
term of this Agreement.
13. DISCLAIMER OF WARRANTIES AND LIMITATION OF LIABILITY
IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER FOR LOST PROFITS,
PUNITIVE OR OTHER INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES OF ANY
KIND ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT. THE
LIMITATION ON LIABILITY SET FORTH IN THIS SECTION SHALL NOT APPLY TO
THE OTHER PARTY'S INDEMNIFICATION OBLIGATIONS UNDER THIS AGREEMENT OR
DAMAGES ARISING OUT OF A PARTY'S INTENTIONAL BREACH OF, OR MISCONDUCT
UNDER, THIS AGREEMENT.
14. MISCELLANEOUS
14.1. Notices. All notices and consents required or permitted to be
given under this Agreement shall be in writing and shall be
deemed to have been duly given if and when (a) delivered
personally, (b) mailed by first class certified mail, return
receipt requested, postage prepaid, on the date certified by
the U.S. Postal Service to have been received by the
addressee, (c) by facsimile, provided the sender personally
calls the recipient and confirms receipt of such facsimile, or
(d) on the date certified by a nationally recognized overnight
express courier service to have been received by the
recipient, as follows:
If to CIMA:
CIMA Labs Inc.
President and Chief Executive Officer
00000 Xxxxxx Xxxx Xxxx
Xxxx Xxxxxxx, XX 00000-0000
Tel: 000-000-0000
Fax: 000-000-0000
If to [***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.***]
14.2. Public Disclosure/Media Releases. Neither party shall issue or
release any media release or public announcement (including
any announcements made via any posting on the World Wide Web
or Internet), or other similar publicity announcing the
existence of this Agreement or relating to any term or
condition of this Agreement in any country or the
relationships created by this Agreement without three (3)
Business Days' prior written notice, including by e-mail, to
the other party and the prior agreement of the other party on
the relevant wording relating to the Agreement or term or
condition of the Agreement. Notwithstanding the foregoing,
each party shall have the right to issue media releases,
immediately and without prior consent of the other party that
disclose any information required by the rules and regulations
of the Securities and Exchange Commission, the New York Stock
Exchange (NYSE), National Association of Securities Dealers
(NASD) or applicable law; provided that the disclosing party
shall notify, including by e-mail, the other party no later
than simultaneously with such issuance of such disclosure and
shall use commercially reasonable efforts to provide a copy of
the relevant wording relating to the Agreement, or any term or
condition thereof to the other party prior to the disclosure
thereof. As of the Effective Date, CIMA shall contact
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
Investor Relations Group for approval and [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] shall contact CIMA's
Chief Financial Officer for approval of such disclosure.
14.3. Relationship Between Parties. The relationship of CIMA to
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
shall be that of an independent contractor, and no provision
of this Agreement shall be construed to constitute any party
as a partner or joint venturer of the other party, or an
employer or employee of the other. Except as may be more
specifically set forth herein, (a) neither party shall be
liable in any manner for the debts and liabilities of the
other party, and (b) each party shall be solely responsible
for all costs and expenses incurred by it in performing its
obligations under this Agreement.
14.4. Force Majeure. Any delays in performance by either party under
this Agreement shall not be construed as a breach of this
Agreement if and to the extent such delay is caused by
occurrences beyond the reasonable control of the party
affected ("Force Majeure"), including but not limited to acts
of God, embargoes, governmental restrictions, strikes or other
concerted acts of workers, fire, flood, explosion, riots,
terrorism, wars, civil disorder, rebellion or sabotage. Delays
caused by events for which a party could have but failed to
take commercially reasonable steps to prevent or compensate
for (e.g. fire insurance, data backup) shall not be considered
to be caused by Force Majeure events. The non-performing party
shall, upon giving written notice to the other party of the
reason for delay, due to Force Majeure, be temporarily excused
from such performance to the extent of such prevention,
interference or delay, provided that the non-performing party
shall use its commercially reasonable efforts to avoid or
remove such causes of non-performance and shall continue
performance with the utmost dispatch whenever such causes are
removed.
14.5. Assignments. Neither party shall voluntarily, by operation of
law or otherwise, assign any of its rights or obligations
under this Agreement without the prior written consent of the
other party, which consent shall not be unreasonably withheld.
Notwithstanding the foregoing, this Agreement may be assigned
by [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***],
without CIMA's consent, as part of an assignment or sale of
all, or substantially all, of its assets to which this
Agreement relates, and [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] may assign its rights and obligations
under this Agreement to an Affiliate; provided, however, that
if an Affiliate that has been assigned any rights or
obligations hereunder, the terms of such assignment shall
contain provisions that if such Affiliate shall no longer be
an Affiliate of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***], such Affiliate shall promptly reconvey such
rights and/or obligations back to [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] or to another
Affiliate designated by [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] that is not a CIMA Competitor. In the
event of a permitted assignment hereunder, the assigning party
shall notify the other party in writing of such assignment. If
pursuant to any permitted assignment hereunder the assignee
does not agree to assume all of the obligations of the
assignor, the assignor shall be liable for all obligations to
the other party not so assumed by the assignee.
14.6. Entire Understanding. This Agreement, along with any other
attachments, appendixes, exhibits, or schedules, states the
entire understanding between the parties with respect to the
subject matter hereof, and supersedes all earlier and
contemporaneous oral and written communications and agreements
or promises made with respect to the same subject matter, and
any other previous agreements, promises, or representations of
any kind with respect to the relationship between the parties
hereto. This Agreement shall not be modified except as
provided in this Agreement or in a written document signed by
both parties. In the event of any differences in
interpretation between the Agreement and any of its
attachments, appendixes, exhibits or schedules, the language
of the Agreement shall govern. This Agreement expressly
supercedes and replaces that certain Startup Development
Agreement dated as of April ___, 2003 between the parties and
all sums paid as of the Effective Date by [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] to CIMA on account of
such Startup Development Agreement shall be credited in full
to the first payments due under this Agreement.
14.7. Controlling Document. In the event of any conflict between the
terms and conditions of this Agreement and any terms and
conditions set forth in any, order, invoice, verbal agreement,
or otherwise, the terms and conditions of this Agreement shall
govern.
14.8. Parties in Interest. This Agreement shall bind CIMA and
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
and their respective successors, agents and permitted assigns,
if any. There are no third party beneficiaries to this
Agreement.
14.9. No Waivers. No failure to exercise, delay in exercising, or
single or partial exercise of any right, power, or remedy by
either party shall constitute a waiver of, or shall preclude
any other or further exercise of, the same or any other right,
power, or remedy.
14.10. Severability. If any provision of this Agreement is construed
to be invalid, illegal, or unenforceable, then the remaining
provisions of this Agreement shall not be affected thereby and
shall be enforceable without regard thereto but construed and
reformed so as to conform as nearly as possible to the intent
of the parties in entering into this Agreement.
14.11. Counterparts. This Agreement may be executed in any number of
counterparts, each of which when so executed and delivered
shall be an
original hereof, and it shall not be necessary, in making
proof of this Agreement, to produce or account for more than
one counterpart hereof.
14.12. Controlling, Law. This Agreement is made under, and shall be
construed and enforced in accordance with, the laws of the
State of Delaware, without regard to that State's conflict of
law rules or principles.
14.13. Jurisdiction and Venue. The parties hereby submit to the
jurisdiction of, and waive any venue objections against, the
United States District Court for the District of Delaware and
the state courts of Delaware, in any litigation or dispute
arising out of this Agreement.
14.14. Headings and References. The headings and captions used in
this Agreement are used for convenience only and are not to be
construed or interpreting this Agreement.
14.15. Parties Represented by Counsel. Each of the parties has been
represented by counsel in the negotiation and drafting of this
Agreement. Both parties have participated in its drafting.
This Agreement shall not be construed against either party on
account of it having been drafted by the other party or by
lack of representation by counsel.
14.16. Costs and Attorney's Fees. The prevailing party in any suit
or proceeding arising out of or relating to this Agreement
shall be entitled to recover all of its reasonable costs and
expenses, including reasonable attorneys' fees.
IN WITNESS WHEREOF, each of the parties has caused this Agreement to be
executed by its duly authorized representative as of the Effective Date.
CIMA LABS INC. [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED
By: /s/ Xxxxxx X. Xxxxxx FILED SEPARATELY WITH THE
---------------------- SECURITIES AND EXCHANGE
Name: Xxxxxx X. Xxxxxx COMMISSION.***]
Title: Chairman & Interim CEO By: /s/ [***CONFIDENTIAL
----
TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE
COMMISSION.***]
Name: [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH
THE SECURITIES AND
EXCHANGE COMMISSION.***]
Title: [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE
COMMISSION.***]
LIST OF SCHEDULES
Schedule 1.3 CIMA Competitors
Schedule 1.5 CIMA Licensed Patents
Schedule 1.10 Developmental Specifications
Schedule 1.26(a) CIMA Trademarks
Schedule 1.26(b) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] Trademarks
Schedule 1.27 Work Plan
Schedule 2.11 Form of Manufacturing Agreement
SCHEDULE 1.3
CIMA COMPETITORS
- Xxxxxxx Company
- Phoqus Pharmaceuticals Ltd.
- Cardinal Health, Drug discovery and development division
- Yamanouchi Pharma Technologies
- Therics, Inc.
- Eurand
- Xx. Xxxxx'x Laboratories Ltd.
- Ethypharm
- Impax Labs, inc.
- Biovail Corporation
- KV Pharmaceutical Inc.
- Capricorn Pharma Inc.
- Intech Pharmaceuticals, Inc.
SCHEDULE 1.5
CIMA PATENTS
OraSolv(R) Technology
U.S. Xxx. No. 5,178,878
U.S. Xxx. App. No. 08/468,913
Australia Xxx. No. 646,232
Austria Xxx. No. E145551
Belgium Xxx. No. 0 494 972
Canada Xxx. No. 2,061,917
Switzerland Xxx. Xx. 0 000 000
Xxxxxxx Xxx. No. 69029273.2
Denmark Xxx. Xx. 0 000 000
Xxxxx Xxx. No. 0000000
Xxxxxx Xxx. Xx. 0 000 000
Xxxxx Xxxxxxx Xxx. Xx. 0 000 000
Xxxxx Xxx. Xx. 0 000 000
Xxxxxx Xxx. Xx. 0 000 000
Xxxxx Xxx. Xx. 0 000 000
Xxxxx Xxx. App. No. 15441/2003
PakSolv(R) Technology
U.S. Xxx. No. 6,155,423
Australia Xxx. No. 732,118
Canada Xxx. App. No. 2284132
Europe Xxx. App. No. 98913352.5 (European Publication No. 1,015,352)
Japan Xxx. App. No. 541960/1998
U.S. Xxx. No. 6,269,615
U.S. Xxx. No. 6,311,462
Australia Xxx. No. 734,383
Europe Xxx. App. No. 99914893.5 (European Publication No. 1,107,911)
Japan Xxx. App. No. 535554/2000
DuraSolv(R) Technology
U.S. Xxx. No. 6,024,981
U.S. Xxx. No. 6,221,392
Australia Xxx. No. 726,336
Canada Xxx. App. No. 2284663
Europe Xxx. App. No. 00000000.9
Japan Xxx. App. No. 544093/1998
SCHEDULE 1.10
DEVELOPMENTAL SPECIFICATIONS
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***]
SCHEDULE 1.26(a)
CIMA TRADEMARKS
CIMA
CIMA LABS INC.
OraSolv(R)
PakSolv(R)
DuraSolv(R)
CIMA
SCHEDULE 1.26(b)
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***]TRADEMARKS
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***]
SCHEDULE 1.27
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***]
